Pink Cir Expert Panel Meeting September 10-11, 2012

PINK

Safety Assessment of Alkyl Esters as Used in Cosmetics

CIR EXPERT PANEL MEETING SEPTEMBER 10-11, 2012 Memorandum

To: CIR Expert Panel Members and Liaisons From: Monice M. Fiume MMF Senior Scientific Analyst/Writer Date: August 17, 2012 Subject: Safety Assessment of Alkyl Esters as Used in Cosmetics; status: draft tentative amended report

Enclosed in the Safety Assessment of Alkyl Esters as Used in Cosmetics; the status of this document is draft tentative amended report for CIR Expert Panel Review.

This document was first considered in March. At that meeting, the Panel agreed to re-open the safety assessment on cetyl esters, a synthetic wax composed of a mixture of esters of saturated fatty acids and fatty alcohols with carbon chain lengths between 14 and 18. (In 1997, the Panel concluded that cetyl esters was safe as used in cosmetics). The review was re-opened not to add new data, but to expand the safety assessment to include similar ingredients. The Panel determined it was appropriate to incorporate all similar ingredients, even those reviewed recently. Thus, a safety assessment on a family of 254 similar ingredients, designated the Alkyl Esters, was created; 60 of the ingredients have been previously reviewed and 194 are “new” ingredients.

As has been done in the past, and is appropriate when a re-review is opened to add new ingredients, the Panel will rely primarily on data from past CIR safety assessments. For your convenience, Table 2 of the report provides summary data and conclusions from past CIR safety assessments on the alkyl esters that have been reviewed previously. You will also receive a Supplemental book that contains these past safety assessments. (Please don’t be confused; the cover is dated March 2012. We have recycled the supplemental book from that meeting).

It is also appropriate to consider the toxicity of the component acid and alcohol of each alkyl ester when assessing the safety of these esters, and the CIR has reviewed a number of the component acids and alcohols. Table 3 provides a breakout of the alkyl esters, indicating for which ingredients both the acid and the alcohol have been reviewed and found safe by the CIR, the acid or the alcohol have been reviewed and found safe by the CIR, or the CIR has not concluded on the safety of either component. (It should be noted that the first category in this table is the list of previously reviewed alkyl esters).

Table 4 provides that conclusions (year issued) for the safety assessments on the component alcohols and acids. Summary data from the safety assessments on the alcohols and acids are not included in this document. However, supplemental books with these safety assessments also are being provided to you. (Again, with a March 2012 cover date). Summary information on some alcohols was included in an appendix to the report on the Dicarboxylic Acid, and although there is no conclusion of safety on those alcohols, you may find that information useful. That summary information is included in the data tab of this Panel book.

Concentration of use data have been provided from industry and submitted by the Council in two submissions. These data, which have been incorporated in Table 8, are included in the data tab of this Panel book.

The data profile is being provided in two formats. First, to facilitate “read-across” of the data, the ingredients are ordered by chain length and chemical structure. Secondly, to facilitate locating an ingredient quickly, the profile is also arranged alphabetically. The data profile on the component alcohol and acids is included between the two.

As a final note, please be aware that the Supplemental books from the March meeting will be available on the CIR website. Also, those original safety assessments will be available in the meeting room at the September meeting, so please don’t think that you need to carry them with you to the meeting.

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Distributed for Comment Only -- Do Not Cite or Quote SAFETY ASSESSMENT FLOW CHART

Draft Priority

Draft Amended Report

Draft Amended 60 day public comment period Tentative Report

Tentative Amended Tentative Report Report

Draft Amended Final Report

Difft. Concl.

Final Report

*The CIRStaff notifies of the public of the decision not to re-open the report and prepares a draft statement for review by the Panel. After Panel review, the statement is issued to the Public. **lf Draft Amended Report (DAR)is available, the Panel may choose to review; if not, CIRstaff prepares DARfor Panel Review. Expert Panel Decision

I i Document for Panel Review Option for Re-review

CIR Panel Book Page 1 Distributed for Comment Only -- Do Not Cite or Quote Alkyl Esters Re-Review History

March 5-6, 2012: original consideration of re-review

The re-review of Cetyl Esters was presented for consideration to re-open. An additional 200 alkyl esters were presented as potential add-on ingredients.

The Panel stated that 52 ingredients (that were included for supporting data but not included for review in the safety assessment) that have been reviewed or re-reviewed previously should also be included in the safety assessment.

The Panel considered an additional 6 ingredients that might have been included, but determined that it was not appropriate. The ingredients that will not be included (for the following reasons) are: decyl hempseedate (hempseedate has not been reviewed); hexyldecyl ester of hydrolyzed collagen (lack of chemical similarity); lauryl Carpotroche brasiliensis seedate; lauryl Theobroma grandiflorum seedate; myristyl Carpotroche brasiliensis seedate; and myristyl Theobroma grandiflorum seedate (these four ingredients have reported function as skin bleaching agents).

A concern was expressed regarding the lack of data on biotransformation of branched fatty acids and branched alcohols in the skin.

September 10-11, 2012: Tentative Amended Report

The safety assessment was revised since the March meeting to include the additional 52 ingredients. Additionally, another unreviewed alkyl ester (Cetyl Myristoleate) was identified and added. The additions resulted in a family of 254 ingredients being evaluated in this safety assessment.

Concentration of use d data were received from industry and incorporated. Frequency of use data were updated using the May 2012 VCRP submission.

CIR Panel Book Page 2 Distributed for Comment Only -- Do Not Cite or Quote Alkyl Esters Data Profile –presented by chain length and structure – Sept 2012 – Writer, Monice Fiume

on-Human on-Human on-Human on_Animal Year Reviewed Composition/Con- stituents/Impurities Mfg of Methods Toxicokinetics Penetration Dermal Acute Tox-Derm Acute Tox-Oral Acute Tox-Inhal Rptd Dose-Derm Rpted Dose-Oral Rptd Dose-Inhal Tox Repro/Dev Genotoxicity Carcinogenicity Derm Irritation- N Derm Sensitization N N Derm Irritation- Human Derm Sensitization Human Human Phototox - Irritation Ocular Phototox- Phototox- Straight chain alkyl ingredients by total length Cetyl Esters 1997 X X X X Caprylyl Butyrate Caprylyl Caprylate Hexyl Laurate Butyl Myristate 2010 X X X X X X X X Decyl Laurate Butyl Stearate 1985* X X X X X X X X X X Arachidyl Propionate 1990* X X X X X X X X X X Stearyl Caprylate 2010 Decyl Myristate 2010 Lauryl Laurate Cetyl Caprylate Tridecyl Laurate Cetyl Caprate Decyl Palmitate Lauryl Myristate 2010 Myristyl Laurate X Tridecyl Myristate 2010 Myristyl Myristate 2010 X X X X X X Cetyl Laurate Lauryl Palmitate X Lauryl Stearate Cetyl Myristate 2010 Tridecyl Stearate Myristyl Stearate 1985* X X X X Cetyl Palmitate 1982* X X X X X X X X X X X Stearyl Palmitate 2010 Cetyl Stearate 1985* X X Lauryl Behenate X Stearyl Heptanoate 2010 X X X X X X X Tridecyl Behenate Stearyl Stearate 2010 Cetyl Behenate X Stearyl Behenate 2010 Arachidyl Behenate Behenyl Behenate Unsaturated, straight chain Heptyl Undecylenate Butyl Oleate X X X X Caprylyl Eicosenoate Decyl Oleate 1982* X X X X X X X Cetyl Myristoleate Lauryl Oleate X Oleyl Myristate 2010 Cetyl Oleate X X Tridecyl Erucate Oleyl Stearate X Stearyl Linoleate Oleyl Oleate X Oleyl Arachidate X Stearyl Erucate Erucyl Oleate Oleyl Erucate Arachidyl Erucate Behenyl Erucate Erucyl Arachidate Erucyl Erucate Lignoceryl Erucate Branched, by longest length Isohexyl Neopentanoate Isopropyl Sorbate Ethylhexyl Neopentanoate Isobutyl Pelargonate 2010 Isodecyl Neopentanoate Ethylhexyl Ethylhexanoate X X

CIR Panel Book Page 3 Distributed for Comment Only -- Do Not Cite or Quote Alkyl Esters Data Profile –presented by chain length and structure – Sept 2012 – Writer, Monice Fiume

on-Human on-Human on-Human on_Animal Year Reviewed Composition/Con- stituents/Impurities Mfg of Methods Toxicokinetics Penetration Dermal Acute Tox-Derm Acute Tox-Oral Acute Tox-Inhal Rptd Dose-Derm Rpted Dose-Oral Rptd Dose-Inhal Tox Repro/Dev Genotoxicity Carcinogenicity Derm Irritation- N Derm Sensitization N N Derm Irritation- Human Derm Sensitization Human Human Phototox - Irritation Ocular Phototox- Phototox- Ethylhexyl Isononanoate 2010 X X Isohexyl Caprate Isopropyl Laurate X Tridecyl Neopentanoate Octyldodecyl Neopentanoate Isodecyl Ethylhexanoate Isononyl Isononanoate 2010 X X X X X X X X Ethylhexyl Pelargonate 2010 X X X Propylheptyl Caprylate X X X X X X X X Isopropyl Myristate 2010 X X X X X X X X X X X X X Myristyl Neopentanoate Isobutyl Myristate 2010 Isohexyl Laurate Isoamyl Laurate Hexyldecyl Ethylhexanoate Isodecyl Isononanoate 2010 X X Lauryl Ethylhexanoate Isopropyl Palmitate 1982* X X X X X X X X X X Ethylhexyl Laurate X X X X X X X X X X Tridecyl Ethylhexanoate Isostearyl Neopentanoate 1985* X X X X X X X X X X Isotridecyl Isononanoate 2010 Ethylhexyl Myristate 2010 Octyldodecyl Ethylhexanoate Octyldodecyl Neodecanoate Isobutyl Palmitate Isopropyl Linoleate 1992 X X X X Isopropyl Oleate X Isopropyl Isostearate 1992* X X X Myristyl Ethylhexanoate Isopropyl Stearate 1985* X X X X Hexyldecyl Hexyldecanoate Decyltetradecyl Ethylhexanoate Isodecyl Laurate X X X X X X Isohexyl Palmitate Isobutyl Stearate 1985* X X X X X X Tridecyl Isononanoate 2010 Butyl Isostearate Ethylhexyl Isopalmitate Isocetyl Ethylhexanoate Ethylhexyl Palmitate 1982* X X X X X X X Cetyl Ethylhexanoate X X Isopropyl Arachidate X Hexyldecyl Laurate Isodecyl Myristate 2010 Isostearyl Ethylhexanoate Hexyl Isostearate Ethylhexyl Isostearate Cetyl Isononanoate 2010 X X X X Isotridecyl Laurate Stearyl Ethylhexanoate Ethylhexyl Stearate 1985* X X X X X X Octyldodecyl Octyldodecanoate Octyldodecyl Myristate 2010 X Butyloctyl Palmitate Ethylhexyl Oleate X Cetyl Dimethyloctanoate Isopropyl Behenate Isocetyl Isodecanoate Isostearyl Isononanoate 2010 Isodecyl Palmitate Isotridecyl Myristate 2010 X Butyloctyl Oleate Hexyldecyl Palmitate Isodecyl Stearate Hexyldecyl Isostearate

CIR Panel Book Page 4 Distributed for Comment Only -- Do Not Cite or Quote Alkyl Esters Data Profile –presented by chain length and structure – Sept 2012 – Writer, Monice Fiume

Stearate Isostearyl Myristate 2010 Isocetyl Palmitate Tetradecyloctadecyl Myristate 2010 Isocetyl Isostearate Myristyl Isostearate Isostearyl Palmitate Isocetyl Stearate 1985* X X X X X X X Isolauryl Behenate Octyldodecyl Behenate Isostearyl Isostearate Octyldodecyl Erucate Isostearyl Linoleate Tetradecyleicosyl Stearate Tetradecyloctadecyl Stearate Isocetyl Behenate Behenyl Isostearate Isostearyl Behenate Isostearyl Erucate Tetradecyloctadecyl Behenate Hydroxy-substituted, by longest length Isopropyl Hydroxystearate Isopropyl Ricinoleate 2007 Ethylhexyl Hydroxystearate Isodecyl Hydroxystearate Heptylundecyl Hydroxystearate Octyldodecyl Ricinoleate 2007 Octyldodecyl Hydroxystearate Cetyl Ricinoleate 2007 X X Hydroxycetyl Isostearate Isostearyl Hydroxystearate Chimyl Isostearate Chimyl Stearate Batyl Isostearate Batyl Stearate Hydroxyoctacosanyl Hydroxystearate Mixtures (alphabetical) Behenyl Beeswax Behenyl/Isostearyl Beeswax Behenyl Olivate Butyl Avocadate Butyl Babassuate Butyloctyl Beeswax Butyloctyl Candelillate Butyloctyl Cetearate C12-13 Alkyl Ethylhexanoate C12-15 Alkyl Ethylhexanoate C14-18 Alkyl Ethylhexanoate C14-30 Alkyl Beeswax C18-38 Alkyl Beeswax C30-50 Alkyl Beeswax C20-40 Alkyl Behenate

CIR Panel Book Page 5 Distributed for Comment Only -- Do Not Cite or Quote Alkyl Esters Data Profile –presented by chain length and structure – Sept 2012 – Writer, Monice Fiume

Esters C4-5 Isoalkyl Cocoate C32-36 Isoalkyl Stearate Coco-Caprylate Coco-Caprylate/Caprate Coco-Rapeseedate Decyl Castorate Decyl Cocoate 2011 Decyl Jojobate Decyl Olivate Decyltetradecyl Cetearate Ethylhexyl Adipate/Palmitate/Stearate Ethylhexyl C10-40 Isoalkyl Acidate Ethylhexyl Cocoate 2011 Ethylhexyl Olivate Hexyldodecyl/Octyldecyl

Hydroxystearate Hydrogenated Castor Oil Behenyl

Esters Hydrogenated Castor Oil Cetyl Esters Hydrogenated Castor Oil Stearyl

Esters Hydrogenated Ethylhexyl Olivate Hydrogenated Ethylhexyl Sesamate Hydrogenated Isocetyl Olivate Hydrogenated Isopropyl Jojobate Isobutyl Tallowate Isodecyl Cocoate 2011 Isooctyl Caprylate/Caprate Isooctyl Tallate Isopropyl Avocadate Isopropyl Babassuate Isopropyl Jojobate Isopropyl Tallowate Isostearyl Avocadate Lauryl Cocoate 2011 Octyldodecyl Avocadoate Octyldodecyl Beeswax Octyldodecyl Cocoate 2011 Octyldodecyl Meadowfoamate Octyldodecyl Olivate Octyldodecyl Safflowerate Stearyl Beeswax Stearyl Olivate 2010 Tetradecylpropionates Tridecyl Cocoate 2010

*indicates that the conclusion was reaffirmed at a later time

CIR Panel Book Page 6 Distributed for Comment Only -- Do Not Cite or Quote Alcohols and Acids Data Profile –presented by chain length or alphabetical – Sept 2012 – Writer, Monice Fiume

on-Human on-Human on-Human on_Animal Year Reviewed Composition/Con- stituents/Impurities Mfg of Methods Toxicokinetics Penetration Dermal Acute Tox-Derm Acute Tox-Oral Acute Tox-Inhal Rptd Dose-Derm Rpted Dose-Oral Rptd Dose-Inhal Tox Repro/Dev Genotoxicity Carcinogenicity Derm Irritation- N Derm Sensitization N N Derm Irritation- Human Derm Sensitization Human Human Phototox - Irritation Ocular Phototox- Phototox- Alcohols Batyl Alcohol 2011 X X X Behenyl Alcohol 1988* X X X Butyl Alcohol 2008 X X X X X X X X X X X X Cetearyl Alcohol 1988* X X X X X X Cetyl Alcohol 1988* X X X X X X X X X X X X X Cetyl Glycol 2011 Chimyl Alcohol 2011 X X X X X X X X Coconut Alcohol 2011 X Isopropyl Alcohol 2010 X X X X X X X Isostearyl Alcohol 1988 X X X X X X X Jojoba Alcohol 2008 X X X X X X X X X Myristyl Alcohol 1988 X X X X X X X X X Octyl Dodecanol 1985 X X X X X X X X Oleyl Alcohol 1985 X X X X X X X X X Stearyl Alcohol 1985 X X X X X X X X X X X Not Reviewed, but data were included in the Appendix to the Dicarboxylic Acid Rpt Caprylic Acid X X Decyl Alcohol X Ethylhexyl Alcohol X X X X Hexyl Alcohol X X Isobutyl Alcohol X Isodecyl Alcohol X Isooctyl Alcohol X X X X Propyl Alcohol X X Acids Adipic Acid 2010 X X X X X X X X X Babassu Acid 2011 Coconut Acid 2011 X X X Hydrolyzed Collagen 1985* X X X X X X X X X X Hydroxystearic Acid 1998 X X X X X X X X Isostearic Acid 1983* X X X X X X X X Lauric Acid 1987* X X X X X X X X Myristic Acid 2010 X X X X X X Oleic Acid 1987* X X X X X X X X X X X X X X Palm Acid 2011 Palmitic Acid 1987* X X X X X X X X X X X Rice Bran Acid 2011 Safflower Acid 2011 Sorbic Acid 1988* X X X X X X X X X X X X Stearic Acid 1987 X X X X X X X X X X X X X Tall Oil Acid 2009 X X X X X X X X

CIR Panel Book Page 7 Distributed for Comment Only -- Do Not Cite or Quote Alkyl Esters Data Profile –presented by chain length and structure – Sept 2012 – Writer, Monice Fiume

Esters C12-13 Alkyl Ethylhexanoate C12-15 Alkyl Ethylhexanoate C14-18 Alkyl Ethylhexanoate C14-30 Alkyl Beeswax C16-36 Alkyl Stearate C18 -38 Alkyl C24-54 Acid Ester C18-38 Alkyl Beeswax C20-40 Alkyl Behenate C20-40 Alkyl Stearate C30-50 Alkyl Beeswax C30-50 Alkyl Stearate C32-36 Isoalkyl Stearate C40-60 Alkyl Stearate C4-5 Isoalkyl Cocoate Caprylyl Butyrate Caprylyl Caprylate Caprylyl Eicosenoate Cetearyl Behenate Cetearyl Candelillate Cetearyl Ethylhexanoate 1982* X X X X X X X X X X X X X Cetearyl Isononanoate 2010 X X X Cetearyl Nonanoate 2010 X X X X X X X X Cetearyl Olivate Cetearyl Palmate Cetearyl Palmitate Cetearyl Rice Branate Cetearyl Stearate Cetyl Babassuate Cetyl Behenate X Cetyl Caprate Cetyl Caprylate Cetyl Dimethyloctanoate Cetyl Ethylhexanoate X X Cetyl Isononanoate 2010 X X X X Cetyl Laurate Cetyl Myristate 2010 Cetyl Myristoleate Cetyl Oleate X X Cetyl Palmitate 1982* X X X X X X X X X X X Cetyl Ricinoleate 2007 X X

CIR Panel Book Page 8 Distributed for Comment Only -- Do Not Cite or Quote Alkyl Esters Data Profile –presented by chain length and structure – Sept 2012 – Writer, Monice Fiume

on-Human on-Human on-Human on_Animal Year Reviewed Composition/Con- stituents/Impurities Mfg of Methods Toxicokinetics Penetration Dermal Acute Tox-Derm Acute Tox-Oral Acute Tox-Inhal Rptd Dose-Derm Rpted Dose-Oral Rptd Dose-Inhal Tox Repro/Dev Genotoxicity Carcinogenicity Derm Irritation- N Derm Sensitization N N Derm Irritation- Human Derm Sensitization Human Human Phototox - Irritation Ocular Phototox- Phototox- Cetyl Stearate 1985* X X Cetyl Tallowate Chimyl Isostearate Chimyl Stearate Coco-Caprylate Coco-Caprylate/Caprate Coco-Rapeseedate Decyl Castorate Decyl Cocoate 2011 Decyl Isostearate Decyl Jojobate Decyl Laurate Decyl Myristate 2010 Decyl Oleate 1982* X X X X X X X Decyl Olivate Decyl Palmitate Decyltetradecyl Cetearate Decyltetradecyl Ethylhexanoate Erucyl Arachidate Erucyl Erucate Erucyl Oleate Ethylhexyl Adipate/Palmitate/Stearate Ethylhexyl C10-40 Isoalkyl Acidate Ethylhexyl Cocoate 2011 Ethylhexyl Ethylhexanoate X X Ethylhexyl Hydroxystearate Ethylhexyl Isononanoate 2010 X X Ethylhexyl Isopalmitate Ethylhexyl Isostearate Ethylhexyl Laurate X X X X X X X X X X Ethylhexyl Myristate 2010 Ethylhexyl Neopentanoate Ethylhexyl Oleate X Ethylhexyl Olivate Ethylhexyl Palmitate 1982* X X X X X X X Ethylhexyl Pelargonate 2010 X X X Ethylhexyl Stearate 1985* X X X X X X Heptyl Undecylenate Heptylundecyl Hydroxystearate Hexyl Isostearate Hexyl Laurate Hexyldecyl Ethylhexanoate Hexyldecyl Hexyldecanoate Hexyldecyl Isostearate Hexyldecyl Laurate Hexyldecyl Oleate Hexyldecyl Palmitate Hexyldecyl Stearate Hexyldodecyl/Octyldecyl

Hydroxystearate Hydrogenated Castor Oil Behenyl

Esters Hydrogenated Castor Oil Cetyl Esters Hydrogenated Castor Oil Stearyl

Esters Hydrogenated Ethylhexyl Olivate Hydrogenated Ethylhexyl Sesamate Hydrogenated Isocetyl Olivate Hydrogenated Isopropyl Jojobate Hydroxycetyl Isostearate Hydroxyoctacosanyl Hydroxystearate Isoamyl Laurate Isobutyl Myristate 2010 Isobutyl Palmitate Isobutyl Pelargonate 2010 Isobutyl Stearate 1985* X X X X X X

CIR Panel Book Page 9 Distributed for Comment Only -- Do Not Cite or Quote Alkyl Esters Data Profile –presented by chain length and structure – Sept 2012 – Writer, Monice Fiume

on-Human on-Human on-Human on_Animal Year Reviewed Composition/Con- stituents/Impurities Mfg of Methods Toxicokinetics Penetration Dermal Acute Tox-Derm Acute Tox-Oral Acute Tox-Inhal Rptd Dose-Derm Rpted Dose-Oral Rptd Dose-Inhal Tox Repro/Dev Genotoxicity Carcinogenicity Derm Irritation- N Derm Sensitization N N Derm Irritation- Human Derm Sensitization Human Human Phototox - Irritation Ocular Phototox- Phototox- Isobutyl Tallowate Isocetyl Behenate Isocetyl Ethylhexanoate Isocetyl Isodecanoate Isocetyl Isostearate Isocetyl Laurate Isocetyl Myristate 2010 X Isocetyl Palmitate Isocetyl Stearate 1985* X X X X X X X Isodecyl Cocoate 2011 Isodecyl Ethylhexanoate Isodecyl Hydroxystearate Isodecyl Isononanoate 2010 X X Isodecyl Laurate X X X X X X Isodecyl Myristate 2010 Isodecyl Neopentanoate Isodecyl Oleate 1982* X X X X X X Isodecyl Palmitate Isodecyl Stearate Isohexyl Caprate Isohexyl Laurate Isohexyl Neopentanoate Isohexyl Palmitate Isolauryl Behenate Isononyl Isononanoate 2010 X X X X X X X X Isooctyl Caprylate/Caprate Isooctyl Tallate Isopropyl Isostearate 1992* X X X Isopropyl Arachidate X Isopropyl Avocadate Isopropyl Babassuate Isopropyl Behenate Isopropyl Hydroxystearate Isopropyl Jojobate Isopropyl Laurate X Isopropyl Linoleate 1992 X X X X Isopropyl Myristate 2010 X X X X X X X X X X X X X Isopropyl Oleate X Isopropyl Palmitate 1982* X X X X X X X X X X Isopropyl Ricinoleate 2007 Isopropyl Sorbate Isopropyl Stearate 1985* X X X X Isopropyl Tallowate Isostearyl Avocadate Isostearyl Behenate Isostearyl Erucate Isostearyl Ethylhexanoate Isostearyl Hydroxystearate Isostearyl Isononanoate 2010 Isostearyl Isostearate Isostearyl Laurate Isostearyl Linoleate Isostearyl Myristate 2010 Isostearyl Neopentanoate 1985* X X X X X X X X X X Isostearyl Palmitate Isotridecyl Isononanoate 2010 Isotridecyl Laurate Isotridecyl Myristate 2010 X Isotridecyl Stearate Lauryl Behenate X Lauryl Cocoate 2011 Lauryl Ethylhexanoate Lauryl Isostearate Lauryl Laurate Lauryl Myristate 2010 Lauryl Oleate X

CIR Panel Book Page 10 Distributed for Comment Only -- Do Not Cite or Quote Alkyl Esters Data Profile –presented by chain length and structure – Sept 2012 – Writer, Monice Fiume

Stearate Octyldodecyl Olivate Octyldodecyl Ricinoleate 2007 Octyldodecyl Safflowerate Oleyl Arachidate X Oleyl Erucate Oleyl Myristate 2010 Oleyl Oleate X Oleyl Stearate X Propylheptyl Caprylate X X X X X X X X Stearyl Beeswax Stearyl Behenate 2010 Stearyl Caprylate 2010 Stearyl Erucate Stearyl Ethylhexanoate Stearyl Heptanoate 2010 X X X X X X X Stearyl Linoleate Stearyl Olivate 2010 Stearyl Palmitate 2010 Stearyl Stearate 2010 Tetradecyleicosyl Stearate Tetradecyloctadecyl Behenate Tetradecyloctadecyl Hexyldecanoate Tetradecyloctadecyl Myristate 2010 Tetradecyloctadecyl Stearate Tetradecylpropionates Tridecyl Behenate Tridecyl Cocoate 2010 Tridecyl Erucate Tridecyl Ethylhexanoate Tridecyl Isononanoate 2010 Tridecyl Laurate Tridecyl Myristate 2010 Tridecyl Neopentanoate Tridecyl Stearate *indicates that the conclusion was reaffirmed at a later time

CIR Panel Book Page 11 Distributed for Comment Only -- Do Not Cite or Quote Search Strategy – Alkyl Esters Re-Review – Sci Finder Search

Keep Me Posted updates are received weekly

July 24, 2012 – Searched all 58 additional ingredients in SciFinder – used 2000 as a cut-off yr for data – 1922 references found for review using qualifiers – 10 papers ordered

Created Keep Me Posted alert in SciFinder for all 58 ingredients

Dec 2011/Jan 2012 – 1638 abstracts found for review using qualifiers; 54 papers ordered Created Keep Me Posted alert

The following were searched in SciFinder Cetyl Esters Caprylyl Butyrate Arachidyl Behenate 110-39-4 42233-14-7 Caprylyl Caprylate Arachidyl Erucate 2306-88-9 86601-86-7 Caprylyl Eicosenoate Arbutinyl Undecylenate Cetearyl Behenate Batyl Isostearate Cetearyl Candelillate Batyl Stearate Cetearyl Olivate 13232-26-3 Cetearyl Palmate Behenyl Beeswax Cetearyl Palmitate Behenyl Behenate 85341-79-3 17671-27-1 Cetearyl Rice Branate Behenyl Erucate Cetearyl Stearate 18312-32-8 93820-97-4 Behenyl Isostearate Cetyl Babassuate Behenyl/Isostearyl Beeswax Ceetyl Behenate Behenyl Olivate Cetyl Caprate Butyl Avocadate Cetyl Caprylate Butyl Babassuate 29710-31-4 Butyl Isostearate Cetyl Dimethyloctanoate 121336-68-3 Cetyl Ethylhexanoate Butyl Oleate 59130-69-7 142-77-8 Cetyl Laurate Butyloctyl Beeswax 20834-06-4 Butyloctyl Behenate Cetyl Oleate Butyloctyl Candelillate 22393-86-8 101227-08-1 Cetyl Tallowate Butyloctyl Cetearate Chimyl Isostearate 101227-08-1 Chimyl Stearate Butyloctyl Oleate 131932-18-8 Butyloctyl Palmitate C10-40 Isoalkyl Acid Octyldodecanol Esters C14-30 Alkyl Beeswax C4-5 Isoalkyl Cocoate C18-38 Alkyl Beeswax C32-36 Isoalkyl Stearate C30-50 Alkyl Beeswax 68201-22-9 C20-40 Alkyl Behenate Coco-Caprylate C18-38 Alkyl C24-54 Acid Ester Coco-Caprylate/Caprate C12-13 Alkyl Ethylhexanoate Coco-Rapeseedate 90411-66-8 Decyl Castorate C12-15 Alkyl Ethylhexanoate Decyl Hempseedate 90411-66-8 Decyl Isostearate C14-18 Alkyl Ethylhexanoate 84605-08-3 C16-36 Alkyl Stearate Decyl Jojobate C20-40 Alkyl Stearate Decyl Laurate C30-50 Alkyl Stearate 36528-28-6 C40-60 Alkyl Stearate Decyl Olivate

CIR Panel Book Page 12 Distributed for Comment Only -- Do Not Cite or Quote Decyl Palmitate Isoamyl Laurate 42232-27-9 6309-51-9 Decyltetradecyl Cetearate Isobutyl Palmitate 97404-34-7 110-34-9 Decyltetradecyl Ethylhexanoate Isobutyl Tallowate Ethylhexyl Adipate/Palmitate/Stearate 68526-50-1 Ethylhexyl C10-40 Isoalkyl Acidate Isocetyl Behenate Ethylhexyl Ethylhexanoate Isocetyl Ethylhexanoate 7425-14-1 125804-19-5 Ethylhexyl Hydroxystearate Isocetyl Isodecanoate 29383-26-4 129588-05-2 29710-25-6 Isocetyl Isostearate Ethylhexyl Isopalmitate 52006-45-8 93843-32-4 Isocetyl Laurate Ethylhexyl Isostearate 89527-28-6 81897-25-8 Isocetyl Palmitate 85186-76-1 127770-27-8 Ethylhexyl Laurate Isodecyl Ethylhexanoate 20292-08-4 89933-26-6 Ethylhexyl Neopentanoate Isodecyl Hydroxystearate Ethylhexyl Oleate 29383-27-5 Ethylhexyl Olivate Isodecyl Laurate Erucyl Arachidate 14779-93-2 Erucyl Erucate 94247-10-6 27640-89-7 Isodecyl Neopentanoate 84605-12-9 60209-82-7 Erucyl Oleate Isodecyl Palmitate 85617-81-8 14779-95-4 Heptyl Undecylenate 59231-33-3 68141-27-5 Isodecyl Stearate Heptylundecyl Hydroxystearate 31565-38-5 Hexyldecyl Ester of Hydrolyzed Collagen Isohexyl Caprate 169590-83-4 138208-67-0 Hexyldecyl Ethylhexanoate Isohexyl Laurate Hexyldecyl Hexyldecanoate 59219-73-7 Hexyldecyl Isostearate Isohexyl Neopentanoate Hexyldecyl Laurate 131141-70-3 34362-27-1 150588-62-8 Hexyldecyl Oleate Isohexyl Palmitate 94278-07-6 55194-91-7 Hexyldecyl Palmitate Isolauryl Behenate 69275-02-1 Isooctyl Caprylate/Caprate Hexyldecyl Stearate Isooctyl Tallate Hexyldodecyl/Octyldecyl Hydroxystearate Isopropyl Arachidate Hexyl Isostearate 26718-90-1 94247-25-3 Isopropyl Avocadate Hexyl Laurate 90990-05-9 34316-64-8 Isopropyl Babassuate Hydrogenated Castor Oil Behenyl Esters Isopropyl Behenate Hydrogenated Castor Oil Cetyl Esters 26718-95-6 438551-45-2 Isopropyl Hydroxystearate Hydrogenated Castor Oil Stearyl Esters Isopropyl Jojobate 438551-44-1 Isopropyl Laurate Hydrogenated Ethylhexyl Olivate 10233-13-3 Hydrogenated Ethylhexyl Sesamate Isopropyl Linoleate Hydrogenated Isocetyl Olivate 22882-95-7 Hydrogenated Isopropyl Jojobate Isopropyl Oleate Hydroxycetyl Isostearate Isopropyl Sorbe Hydroxyoctacosanyl Hydroxystearate 112-11-8 93840-71-2 17364-07-7 Isopropyl Sorbate

CIR Panel Book Page 13 Distributed for Comment Only -- Do Not Cite or Quote Isopropyl Tallowate 69275-04-3 Isostearyl Avocadate Octyldodecyl Hydroxystearate 90990-06-0 Octyldodecyl Isostearate Isostearyl Behenate 93803-87-3 125804-16-2 Octyldodecyl Meadowfoamate Isostearyl Erucate Octyldodecyl Neodecanoate 84605-10-7 Octyldodecyl Neopentanoate Isostearyl Ethylhexanoate Octyldodecyl Octyldodecanoate Isostearyl Hydroxystearate Octyldodecyl Oleate 162888-05-3 22801-45-2 Isostearyl Isostearate Octyldodecyl Olivate 41669-30-1 22801-45-2 Isostearyl Laurate Octyldodecyl Safflowerate 72576-79-5 Octyldodecyl Stearate Isostearyl Linoleate 22766-82-1 127358-80-9 Oleyl Arachidate Isostearyl Palmitate 22393-96-0 69247-83-2 156952-79-3 72576-80-8 Oleyl Erucate Isotridecyl Laurate 17673-56-2 94134-83-5 143485-69-2 Isotridecyl Stearate Oleyl Linoleate 31565-37-4 17673-59-5 Lauryl Behenate Oleyl Oleate 42233-07-8 3687-45-4 Lauryl Carpotroche Brasiliensis Seedate 17363-94-9 Lauryl Ethylhexanoate Oleyl Stearate 56078-38-7 17673-50-6 Lauryl Isostearate 33057-39-5 93803-85-1 Propylheptyl Caprylate Lauryl Laurate 868839-23-0 13945-76-1 Stearyl Beeswax Lauryl Oleate Stearyl Erucate 36078-10-1 86601-84-5 Lauryl Palmitate 96810-34-3 42232-29-1 Stearyl Ethylhexanoate Lauryl Stearate 59130-70-0 5303-25-3 Stearyl Linoleate Lauryl Theobroma Grandiflorum Seedate 17673-53-9 Lignoceryl Erucate Tetradecyleicosyl Stearate Myristyl Carpotroche Brasiliensis Seedate Tetradecyloctadecyl Behenate Myristyl Ethylhexanoate Tetradecyloctadecyl Hexyldecanoate Myristyl Isostearate 93982-00-4 94247-26-4 Tetradecyloctadecyl Stearate Myristyl Laurate Tetradecylpropionates 22412-97-1 Tridecyl Behenate Myristyl Neopentanoate 42233-08-9 144610-93-5 Tridecyl Erucate Myristyl Theobroma Grandiflorum Seedate 131154-74-0 Octyldecyl Oleate Tridecyl Ethylhexanoate Octyldodecyl Avocadoate Tridecyl Laurate Octyldodecyl Beeswax 36665-67-5 Octyldodecyl Behenate Tridecyl Neopentanoate 125804-08-2 106436-39-9 Octyldodecyl Erucate Tridecyl Stearate 88103-59-7 31556-45-3 Octyldodecyl Ethylhexanoate

Other search sites - Jan 2012 searched ChemPortal; NTP, IARC, EU, FDA – spme hjits in Chem Portal, 0 in NTP and IARC

CIR Panel Book Page 14 Transcript

Distributed for Comment Only -- Do Not Cite or Quote Full Panel – March 6, 2012

We'll move on then to the next ingredient, the alkyl esters, by Dr. Belsito. DR. BELSITO: Back in 1997 we issued a final report on cetyl esters with a safe as used conclusion so that this is coming back for a re review. The first question is is there any new information on cetyl esters that would cause us to open the report and our answer was no. Then the next question was are there other alkyl esters that could be brought into this report including isopropyl linoleic which we had previously found insufficient because we didn't have a concentration at which it was irritating. That was what was holding us up, and we now have realized that irritation is a very difficult thing to regulate. It's all with formulation. So we wanted to move ahead and reopen the report, bring all of the alkyl esters, even those that are not up for review currently, into one alkyl ester document. Then going over to Panel Book 54, the actual page 33 and Table 1 A of the potential add ons, we wanted to keep them all except for decyl hempseedate, hexyldecyl ester of hydrolyzed collagen, lauryl carpotroche brasiliensis seedate, lauryl theobroma grandiflorum seedate, myristyl carpotroche brasiliensis seedate and myristal theobroma grandiflorum seedate and eliminate those six, the last four because they were reported to have some bleaching activity and would not be a no brainer to add them in, the other two because of lack of data on the hempseed oil and also Dan felt the hydrolyzed collagen was the main mover in that ester. We also discussed on the following page, this is Table 1 B, where Monice had indicated ingredients for which none of the individual constituents have been reviewed. While that's true, for instance in the case of ethylhexanoate, we have reviewed hexanoates, we haven't reviewed hexanoic acid, but in reviewing hexanoates, and that was the cetyl octanoate which is now cetyl ethylhexanoate, we looked at in this instance specifically teratology that was supposedly associated with ethylhexanoic acid, it was due to zinc accumulation as was found not to be relevant to humans and we elected not to reopen that report. That table is a little misleading in the sense that while we haven't looked at the acid, we have looked at many of those sales and while we haven't looked at the specific alcohol, we've looked at the alcohol in other reports. With that in mind, we wanted to go ahead and open it for all on that list except the six I mentioned. DR. MARKS: We concern with the reopening of this report. We hadn't settled exactly on which ingredients. We discussed the issue of no brainers that Wilma had brought up earlier this morning. So if we go to Table 1 B which you referred to, Don, on page 54, clearly the top part in which all the constituents had been reviewed by the CIR was a no brainer. Some of the constituents in that middle portion would be no brainers like cetyl and decyl laurate which are quite simple. Some of that third category where none had been reviewed but actually there had been some alcohols and acids, so we were going to ask to have this re presented as to what would be suggested to be reviewed, eliminating the ones which are no brainers. You've obviously going through in more detail. Table 2 which is on page 55, alkyl esters previously reviewed in other safety assessments, we would include those too just to group it all together. That's at the top of the page. I think what we'll do is see that group that you suggested with those ones eliminated and then our team will go over that and react to it. DR. BERGFELD: What you're saying is that you're agreeing to reopen? DR. MARKS: Absolutely. DR. BERGFELD: We'll vote on that in a moment. As far as the constituents that will be reviewed, I'm not clear on that. DR. MARKS: I think we'll start with the Belsito team's ingredients and then as our team looks at them we may have some different opinion, but we would start with the ones suggested by Dr. Belsito's team. DR. BERGFELD: And the no brainers that you indicated as well? DR. MARKS: That would be included. DR. BERGFELD: Is that included? DR. BELSITO: We want to take all of the ingredients in Table 2 even though they're not up for current review and put them into a master alkyl esters. DR. BERGFELD: We'll call for the vote then. Ron? DR. HILL: I wanted to point out, and I'm just a lowly medicinal chemist, there are a number of the branched acids that have not been reviewed either as acids or as esters, and a few of the branched alcohols that have not been reviewed either as the alcohol themselves or as esters of that alcohol. I went through last night or yesterday afternoon and early this morning and marked the ones that I thought were excluded by gaps in toxicology data where there is no data on those compounds. So if there are interested parties, I think it's time to start looking at every branched fatty acid just because it has the same number of carbons as innocuous without information to that effect from my point of view. The discomfit level is primarily because if we knew the branching was in certain positions and we have biological capability of dealing with those, that's fine, but we're not getting specific structures on these isos. To me in this day and age where mass spectroscopy can easily fish apart what those exact structures are and tell us what the composition of those mixtures are, I think it's let me just use the word ridiculous that we don't know the exact components of them so that we can do the read across knowing exactly what compounds have been studied. That's the way I feel about it. DR. BERGFELD: The issue is to reopen or not.

CIR Panel Book Page 15 Distributed for Comment Only -- Do Not Cite or Quote DR. HILL: I'm okay with reopening. Jay made the comment that if we somehow cast aspersion on compounds that aren't in trouble and are in current use right now by reopening he was not happy with that consequence. DR. BERGFELD: Good. Is there any other comment? DR. BELSITO: I think again let's take a look. I think that there is a lot of homework that wasn't done and rightfully shouldn't have been until we decide exactly what we're going to look at. Why waste time if we've kicked out half of them right at the start? Let's take a look again. I'll ask Dan to comment on his concerns regarding what Ron just said. DR. LIEBLER: This is an old discussion and I think we'll continue to have it. Let's proceed as we talked about and I'm sure there will be plenty to talk about later. DR. HILL: One thing I might add is that I think most if not all of the ones that I X'd out don't seem to be in current use or at least by reporting. DR. BERGFELD: You did a lot of homework. There are a lot of ingredients there. I'll move the question then to reopen. All those in favor please indicate by raising your hand. Thank you. Unanimous. The numbers and what ingredients will be included will be discussed at a later date when this document is represented to us. Thank you. Go ahead, Alan. DR. ANDERSEN: I think for purposes though of taking the next step the list as described by Dr. Belsito is the operative list so that as the council moves forward to gather use concentration data at least we have a presumptive list established. That we might modify that later is always a possibility, but right now we have a target list. DR. BERGFELD: Well taken.

Belsito Team – March 5, 2012

DR. BELSITO: Oh, yes. Okay, so, alkyl esters, this is a re review. In 1997, we issued a final report on cetyl esters, which safe as used. And, so, the questions before us are whether we need to reopen the cetyl ester and if the answer to that is no, which I think it is, then the second question becomes: Do we reopen to add a whole bunch of other alkyl esters that we haven't reviewed before? And some that we have reviewed, do we make a family? And I think we should reopen it and include all the other alkyl esters, including isopropyl linoleic, which we previously went insufficient because at that mode, we were in the okay, if you can't give us a non irritating concentration, we'll go insufficient and now we've taken the approach when formulated to be non irritating. So, at least when I went back and re reviewed the isopropyl linoleic, which is the one alkyl ester that we found insufficient, that was the reasoning. So, if my team feels like we should reopen it, then the question goes to Dan. Are there any of these alkyl esters that you feel we should pick at? DR. LIEBLER: Yes, so, I agree with you on reopening and my initial survey here suggests that we would include all the ingredients except for the hydrolyzed collagen compound and the seedates and the seedates and the seedates, I'm provisionally recommending that they be excluded because I don't really know what they are. If someone can explain to me if they're highly enriched and purified for the ester components, then I'm okay with it, but if there's a less well defined mixture, then I would suggest the seedates not be included. Otherwise, collagen doesn't belong with this group. I also had a red flag on the isopropyl sorbate. The compound looks like a mikylreceptor so called chemically reactive species, and the sorbate sounds familiar to me and I'm not sure that there's precedent for it in other reviews that had been previously reviewed, any sorbate derivatives. DR. BELSITO: Well, we've done ascorbic acid, right? MS. FIUME: I think we have, yes. DR. LIEBLER: Okay, so, it must be okay. Anyway, the hydrolyzed collagen compound and the seedates, I would recommend not including. The others, I was okay with. DR. SNYDER: So, we have DR. BELSITO: And when you DR. SNYDER: I remember the seedates also being (inaudible). MS. FIUME: Ascorbic acid (inaudible). DR. SNYDER: Okay, thank you. DR. BELSITO: What are referring to as seedate? MS. FIUME: We reviewed seedates DR. BELSITO: Oh, yes. Okay. Oh, the seedate. Seedate. Yes.

CIR Panel Book Page 16 Distributed for Comment Only -- Do Not Cite or Quote SPEAKER: That's what I was thinking. DR. BELSITO: Yes. Yes. I removed those, also, because DR. LIEBLER: The seedates. DR. BELSITO: Because the supposed bleaching activity. DR. LIEBLER: Oh, okay. DR. BELSITO: So, the lauryl, theobroma, and grandiflora, those three? So, you're recommending that the lauryl, the myristyl, carpotroche, and the myristyl theobroma, those three be removed? DR. EISENMANN: Also, decyl hempseedate, which we've never done hempseed oil. DR. BELSITO: Well, there must a lot of data on that. (Laughter) SPEAKER: They're highly technical. MS. BRESLAWEC: It's still being tested. DR. BELSITO: Okay. So DR. LIEBLER: In another large box of potato chips. SPEAKER: Get table 11 out. SPEAKER: Table 11. DR. BELSITO: So, we're going to remove all the seedates of which I've got four so far. DR. KLAASSEN: What page? DR. BELSITO: Page 53. DR. EISENMANN: Now, what's the difference between something like a name that ends in seedate and you've got like babassuate, which is, again, a mixture of fatty acid from Babassu oil, I guess, or avocado? DR. BELSITO: Well, I mean DR. LIEBLER: I only suggested we do the ones literally that said seedate. DR. EISENMANN: Okay. DR. LIEBLER: I recognize that some of them that are like avacadoate, for example, that's avocado oils, but the DR. BELSITO: What about rapeseedate? DR. LIEBLER: I think I flagged it. MS. FIUME: Potassium rapeseedate was part of DR. BELSITO: The rapeseed oil report. MS. FIUME: I think it's the vegetable oil report. DR. LIEBLER: Oh. DR. BELSITO: Yes. MS. FIUME: Yes, so, we've done rapeseedate before. DR. LIEBLER: Coco rapeseedate, yes. DR. BELSITO: And hempseedate? MS. FIUME: I don't think we have any precedence for that. DR. LIEBLER: So, just to clarify for my purposes, the seedate is a purified extract which contains these alkyl esters? Do we know that? The main reason I flagged those to be removed is because I wasn't clear about that point. DR. BELSITO: I think it's like the way I read it is the alkyl ester that's extracted from rapeseed DR. EISENMANN: The fatty acids aren't from rapeseed. DR. BELSITO: Right. DR. EISENMANN: And then reactive with whatever. DR. BELSITO: Right. MS. FIUME: Yes. So, this is the definition of the rapeseedate. DR. LIEBLER: Okay, so, potassium rapeseedate is the potassium salt with fatty acids derived from brassica napus, rapeseed oil.

CIR Panel Book Page 17 Distributed for Comment Only -- Do Not Cite or Quote SPEAKER: But that's basically the oil. So, okay, then that actually changes things in my view. DR. BELSITO: Yes, I just got rid of the three, the myristyl carpotroche was only in seedate. The myristyl theobroma and the florum seedate and the MS. FIUME: Is it the lauryl carpotroche? DR. LIEBLER: Carpotroche. DR. SNYDER: Myristyl and lauryl (inaudible) both the theobroma and the carpotroche. DR. BELSITO: Yes. So, I got rid of the Brasiliensis and the grandiflorum seedates. DR. SNYDER: Okay. DR. BELSITO: And all of the florums because of this bleaching activity that was reported. DR. LIEBLER: Yes, I got those flagged, too. Okay. MS. FIUME: So, is the hempseedate out of luck? DR. BELSITO: I don't know. DR. LIEBLER: No, actually MS. FIUME: No. DR. LIEBLER: The only seedates I flagged were the four that Don just mentioned. I should have looked at my little notes here. DR. BELSITO: Hempseedate? DR. EISENMANN: We have reviewed hempseed oil before. MS. FIUME: Yes. DR. EISENMANN: So, I don't know what DR. BELSITO: Okay. Well, then take out hempseedate. It sounds like a children's nursery rhyme, right? Do si dos and (inaudible) seed oil. DR. EISENMANN: What is the full name for the hempseedate? SPEAKER: Decyl hempseedate. DR. LIEBLER: Yes. DR. BELSITO: First column, Panel Book 53, page 33. DR. EISENMANN: Thank you very much. DR. SNYDER: So, what about this whole table here of the ingredients which (inaudible) and they're not used. Reportedly used. DR. BELSITO: Well DR. LIEBLER: Bottom of page 54, correct? DR. BELSITO: Yes. DR. LIEBLER: So, what are you suggesting with those? DR. SNYDER: Well, none of them are reported to be used. None of the constituents have been reviewed. Removed, but not used, but not reviewed. DR. BELSITO: I mean, ethylhexanoic is octanoic and we've reviewed it and the original report was cetearyl octanoate. And, in fact, ethyl hexanoate subsequently created some issues in terms of toxicity that we looked at when we re reviewed it in 2004, 2005, in terms of reproductive and developmental toxicity that we ended up concluding was due to zinc deficiency in rodents and was not pertinent to humans. The cetarol octanoate now cetyl ethyl hexanoate. So, we have done ethyl hexanoates before. It was just called octanoate. So, there's a second part that I think is critical because of the studies that occurred regarding developmental toxicity of cetarol ethyl hexanoate, and, in fact, when we reviewed it back in I just snagged this. It was the old way of reviewing where we just listed chemicals, but if you look on the page I'm sorry, I don't have the page here, but we looked at that data and we thought it was species specific zinc deficiency and had nothing to do with the humans and, therefore, we declined to reopen the cetarol ethyl hexanoate report. DR. LIEBLER: Are you saying cetarol ethyl hexanoate and cetarol octanoate are the same or DR. BELSITO: Yes. DR. LIEBLER: No, they're not both DR. BELSITO: CIR renamed them.

CIR Panel Book Page 18 Distributed for Comment Only -- Do Not Cite or Quote DR. LIEBLER: I mean, chemically, octal would be straight DR. BELSITO: Octa. MS. FIUME: Octanoic. DR. BELSITO: Octanoic acid. MS. FIUME: O C T A. DR. BELSITO: O C T A. MS. FIUME: N O A T E. As I look down here, if I said the individual constituents haven't been reviewed, it was a one for one. Like, so, if it was ethyl hexanoic acid or octanoic acid, it wasn't specifically reviewed, it was put there. It wasn't that the family had been reviewed. So, I'm sorry if I'm misleading you on that. It was a literal frontend, backend part of the name. Has the constituent been reviewed? And I can change that. I can look at the family groups and move them up. It was truly like I looked at the acid, I looked at the alcohol in those direct acids that didn't have a conclusion on the bottom. DR. BELSITO: I see. DR. LIEBLER: So, for caprylate, you're saying caprylic alcohol has not been reviewed, nor has caprylic acid? MS. FIUME: Correct. Well, let me check. DR. LIEBLER: I'm just wondering. That doesn't seem right. MS. FIUME: The alcohols caprylic? DR. LIEBLER: Right. MS. FIUME: Unless it has a different name, it's not even in the unless I spelled it wrong. DR. LIEBLER: Oh, well. MS. FIUME: It's not in the database. DR. LIEBLER: If you spelled it right, caprylic acid and caprylate. DR. SNYDER: So (inaudible) qualify on page 25. Page 25. DR. BELSITO: Let's wait for them to finish up there. DR. LIEBLER: Okay. MS. FIUME: Yes. So, a family of it may have been reviewed, but the specific acid or the specific alcohol were not. DR. LIEBLER: So, caprylic acid could have been present in a family that was reviewed? MS. FIUME: Yes. DR. LIEBLER: But the specific compound wasn't? MS. FIUME: Yes. I mean, I know that's true for the ethyl hexanoate and the neopentanoate. DR. LIEBLER: So, back to Paul's original question about DR. BELSITO: But in a sense though I'm sorry to interrupt you. DR. LIEBLER: Yes. DR. BELSITO: They were reviewed because, for instance, in our re review of cetearyl octanoate, which substantively was called cetearyl ethyl hexanoate, we, for instance, looked at this paper by Penneman on the effects of 2 ethylhexanoic acid on reproduction and postnatal development in (inaudible) rats. That was the whole issue of repro tox and went through it and looked at it and came up with a conclusion that that effect was due to a zinc deficiency that was peculiar to those rodents and we looked at this paper by Collins, et al., on (inaudible) sodium 2 ethylhexanoate. So, in a way, although we didn't do ethylhexanoic acid, maybe because it's not in the dictionary, we did look at effects because, presumably, there will be some metabolism in the skin that will result in the product of ethyl hexanoic acid. So, I think if we somewhat reviewed ethyl hexanoates in some fashion, then I don't think you can be absolutely certain, but we must have considered the toxicological effects of the acid. MS. FIUME: Okay. So, then, I will revamp that list, but then it makes it considerably shorter because and I guess not knowing the chemistry to make sure that they do overlap the behenates, the neopentanoates, ethylhexanoates, they would all bump up then. DR. LIEBLER: Right. DR. BELSITO: I mean, I was of the opinion that with the exception of the four theobroma, grandiflorum, and carpotroche Brasiliensis, and primarily because they reported to have bleaching activity, we could probably keep all of these and DR. LIEBLER: Yes.

CIR Panel Book Page 19 Distributed for Comment Only -- Do Not Cite or Quote DR. BELSITO: And at industry's request, we'll take out hempseedate. DR. EISENMANN: And the other one is collagen, right? DR. LIEBLER: Hydrolyzed collagen. DR. SNYDER: Right. DR. BELSITO: And that's because, Dan, you just because we've done hydrolyzed collagen. DR. LIEBLER: Yes, it's true that we have; it's just that it's so very different chemically from everything else on this list. DR. BELSITO: Okay. DR. LIEBLER: It's got entirely different properties. DR. BELSITO: So, we're taking six DR. LIEBLER: This is the main list. DR. BELSITO: Right. DR. LIEBLER: This is the ones that have been reviewed. DR. BELSITO: Okay. DR. LIEBLER: Just four or five or six of them. DR. EISENMANN: Monice, one question for you. MS. FIUME: Yes. DR. EISENMANN: The ingredients that cetyl esters were based on, are those in here? I can't remember. I thought maybe there's still a few. I just wondered if you wanted to pull a bunch of ingredients, as the based ingredients are in here. I know you've reviewed them and I think they've been re reviewed, but I was not convinced that they were in here. MS. FIUME: You mean the mixture that was actually in cetyl esters? DR. EISENMANN: Yes, the individual components that are part of cetyl esters or other esters, if you look at the original report, there wasn't much data and the original cetyl esters report was for dual author ingredients. MS. FIUME: What we did in determining, which were included, and that's why there's two lists, if they were re reviewed, we didn't bring them back in here. The panel has done it. We have in the past because we looked at it and a re review was done on the ingredient. That's what table 2 is, the list of previously reviewed ingredients in another safety assessment that weren't being included as add ons. DR. BELSITO: I think they should all be brought in. MS. FIUME: And some of the words recent as five years ago, but you would like to see them all brought in? DR. BELSITO: Yes. MS. FIUME: Okay. DR. BELSITO: Again, we've had this discussion before. I mean, let's bring all the alkyl esters in and there's strength in number of data and then we covered them all rather than, oh, three years from now, we have to do another alkyl ester, why don't we add it in? DR. LIEBLER: Right. DR. BELSITO: And I think my feeling is as we move through this, if there are ones out there that we reviewed that aren't due for re review that belong in a document, they should go in the document. MS. FIUME: All right. So, that will bump the number up by 58. DR. LIEBLER: Who's counting? (Laughter) DR. SNYDER: So, isopropyl linoleic. (inaudible) one that we all reviewed before doing re review of 1992 report DR. BELSITO: Right. DR. SNYDER: It went out insufficient. DR. BELSITO: Yes, but it was insufficient for irritation. DR. SNYDER: For irritation, okay. DR. BELSITO: And we now deal with that by saying when formulated to be non irritating. DR. SNYDER: I just did not know what the insufficiencies DR. BELSITO: Yes.

CIR Panel Book Page 20 Distributed for Comment Only -- Do Not Cite or Quote MS. FIUME: So, now, Carol because the definition just says that the mixture of esters of 14 to 18 carbon fatty acids in alcohol, they should all be covered now, right, bringing in those 58? DR. EISENMANN: I think so. MS. FIUME: Okay. DR. BELSITO: And on page 6 of the document, page 6 of the book, Panel Book 26, so, I mean, I'm ready to bring them all in in just safe as used (inaudible). But there's mention of penetration enhancement, and so, I think that that needs to be brought out. At the top of the page, penetrate alkyl esters of indomethacin. So, in the discussion, penetration enhancement, and I think even though we dealt with it in the original re review of cetarol ethylhexanoate, the reproductive and postnatal toxicity of the ethylhexanoic acid should be brought back up in the discussion of this and it was very well covered in our decision not to reopen cetarol octanoate. That 2 ethylhexanoic acid, maternal liver toxicity begins a cascade of effects. It includes Metallothionein induction, zinc accumulation of liver, and zinc deficiency in a developing embryo and that it's not pertinent to humans. So, I would bring that into this report since it's not the only ethyl hexanoate that's going on. There have been issues raised about reproductive toxicity of ethyl hexanoate acid. The panel, here's the deal. DR. SNYDER: Yes, that was my comment, too, because we talked about the category 3 (inaudible) category, category 3 n page 25 of the Panel Book. So, we need to explain why we're not concerned about that in the discussion. MS. FIUME: And then I did want to explain what I did to make sure if the report goes forward to the next stage that you're okay with it. In the past, when we've relied on previous data, we've summarized the reports that were summarized in the previous document. So, with the number of ingredients that we're for lack of a better word reading across too, rather than reiterating that again and again, that's why there are a couple versions of the data profile. So, I just want to make sure you're okay with all that data being re summarized again to go in the journal again as summary information as the report goes forward. Is that okay? DR. SNYDER: Yes, that looks good. DR. BELSITO: Okay, so, six deletions from Table 1A, creation of a new table where the alcohol or the acid may not have been reviewed, but the ester or some related family has been reviewed, and safe as used, discussion, penetration enhancement, and the repro, why we don't think the repro toxicity of isohexanoic acid is an issue, as we discussed in our decision not to reopen cetyl ethylhexanoate. MS. FIUME: And then bring in the additional 58? DR. BELSITO: Sure, yes. DR. ANDERSEN: Now, and what was that data count again, you deleted? MS. FIUME: Deleted 6, added the 58. DR. ANDERSEN: Added 58. DR. EISENMANN: But who's counting? DR. ANDERSEN: Got to love it.

Marks Team – March 5, 2012

If not, we'll move on to the alkyl esters. This is a re-review. In '97 the panel issued a final report on cetyl esters as safe; a number of supplemental books now. So first of all are the cetyl esters. We're into the mode with a reopening or re-review. Is there any new data to suggest that in the original report there are any safety alerts? Should we reopen it for that reason? DR. SHANK: I think we can change -- so the answer's yes. I think in the 1992 report, we concluded that isopropyl linoleate is -- let's see -- DR. MARKS: Insufficient I have. DR. SHANK: It was insufficient. But we have isopropyl alcohol has been found to be safe and ten esters have been found to be safe. These are included as tables. And the oil report should have covered linoleic acid. So I think we could now change that conclusion and then open it to add the acid and the alcohol. MS. FIUME: Just to clarify, the re-review is on the ingredient cetyl esters itself, and then the rest such as I think isopropyl linoleate would come under ingredients to reopen to add. Is that correct? DR. SHANK: Right, reopen to add. DR. MARKS: And are we adding 200 ingredients? Is that correct? DR. SHANK: Let's see -- DR. MARKS: So I have on page 33 and 53 -- yes, okay. So 33 we -- actually 32 we do the structures. Rons and Tom, which would

CIR Panel Book Page 21 Distributed for Comment Only -- Do Not Cite or Quote you prefer? Starting on 32 and work on the structures, or go to Panel Book 53 and look at the Table 1A with all these? Again, these should be basically no-brainers again if we're going to add on. It's a lot of ingredients. DR. SLAGA: I think the structures would be fine. DR. MARKS: Structures, so is there -- as we go down the structures on page 32, 33, all the way up to page 51 -- Monice, thank you, you numbered all these -- starts with cetyl esters on ingredient 1 and we go up to 200, stearyl beeswax. Anything on all these ingredients which would not be a no- brainer that we would be concerned about? DR. HILL: Define "no-brainer." Do you mean that you're going to be -- that I'm going to feel satisfied with read-across? Is that what you mean? DR. MARKS: Yes. DR. HILL: Oh. DR. MARKS: And what we have already, or what we have in previous reports as what Ron mentioned with the isopropyl linoleate. DR. HILL: So we have a whole bunch of branched carboxylic acids in here with no toxicology data captured, no previous reviews that include them. DR. MARKS: So you're starting on page 35, number 40. DR. HILL: Well, the thing is that they mixed -- I like the organization except they mixed branched fatty acid or branched acid ones with branched alcohol ones, which is fine. But it's actually more helpful to separate them because we do have a few branched alcohols that we do have past toxicology data on. I don't think any of these acids we actually have ever captured previously, except not in my time on the panel, have we captured toxicological evaluations. Now honest opinion, I didn't see any good reason to remove any of these. But if you're wanting to strictly adhere to the no-brainer rule, then I have a totally different view. DR. MARKS: I'm trying to remember the rules of engagement. Ron Shank and Tom, they're salts -- DR. HILL: Simple esters -- DR. MARKS: Simple esters, right. DR. HILL: Which are not easily well defined I think. DR. MARKS: Right. So, Jay? DR. ANSELL: Well, I was just going to -- I think the intent is what you said, that the data should be available to review them within the existing report. What we would not want to have happen is to reopen it to add an ingredient and then determine the information was insufficient to support that and go insufficient on an ingredient which was added. If it is insufficient, then the conclusion has to be that the grouping was done badly, not that the report is insufficient. And so it's a statement of principle that that's where we come from as opposed to trying to remember whether it was salts or esters. DR. MARKS: Right. You captured that nicely, Jay, thank you. So does that help in deciding? Do we want to do all 200? Do we want to limit it? Or do we want to reopen only to add isopropyl linoleate? Or do we want to not reopen and do isopropyl linoleate since it was a separate report before as a separate one again as a re-review? DR. SLAGA: Would it be worthwhile to do what Ron stated about the branched alcohols versus the branched esters, further subdivided just so it makes it clear? DR. MARKS: I guess the question -- we can certainly divide the branched alcohol and esters, but we have a lot of other ones in here, too. So I guess the question is how do you deal with this? So on page 32, is there anything that is a problem with 1 to 10? And then we could go to page 33. Is there anything from 11 to 21? Yeah, Ron Shank. DR. SHANK: Well, if I could call your attention to Panel Book page 54, Monice has a table here, Table 1B, which was very helpful to me. The first section of the table says "ingredients for which all constituents have been reviewed by CIR." Those are no-brainers to me as add-ons. And then all of the others have some limitations. MS. FIUME: Actually, if I can add a point of clarification, and I apologize if this is confusing. At the bottom, the third section of that table, I have that "the constituents weren't reviewed." When I said that, it meant the direct alcohol or the direct acid, but there are some in there whose family may have been reviewed and I apologize for that -- such as the ethyl hexanoates or the neopentanoates. There were other neopentanoates that were reviewed, but the direct of the acid itself was not reviewed. So I apologize for that confusion. DR. MARKS: So again, Ron, on page 54 you're saying on Table 1B the first group is a no-brainer. All the constituents have been reviewed. DR. SHANK: Yes, that first section. DR. MARKS: And then the ones below in which one constituent has been reviewed or again that could be adjusted. The third group down there, none. Essentially a no-brainer would be just the top, which is still a lot of ingredients. But then we could truly say it's a no-brainer, huh?

CIR Panel Book Page 22 Distributed for Comment Only -- Do Not Cite or Quote Ron Hill and Tom, do you like that approach to it? DR. HILL: Well, if we could figure out which ones fall into the category she just mentioned and bump them up, I mean, that'd be another possibility as long as we do it right. DR. MARKS: Yeah, I think what we would -- DR. HILL: That's not a 5 minute job. MS. FIUME: I could have it for tomorrow. DR. MARKS: Oh, no. MS. FIUME: I would hate to try and guess it for today. DR. MARKS: Yeah, so I think I don't know that we need it for tomorrow unless the team feels it. I think it's just we endorse that idea that we could include that as a no- brainer and the next time we see it, we can deal with that. And if we don't think it's a no-brainer, we just eliminate it. DR. SHANK: The decision is to reopen to add new ingredients. DR. MARKS: Correct. DR. SHANK: We can say which ingredients after we get the updated list. DR. MARKS: Right, but we can certainly begin with that top list on Table 1B as all those would be included. DR. BERGFELD: So you're proposing that all of the rest that are listed here have some research involved with them? It would cover portions or part if there'd been any problems with the chemical? DR. MARKS: Yeah, if one constituent. If there's more than -- DR. SLAGA: Yeah, it's more that we don't have data, not that there's something wrong with them. We just don't have data if there's one constituent missing or both of them. DR. HELDRETH: So I have a question about that. So then you're saying that the ones in the second group being on that page wouldn't be no-brainers. So you're saying something like decyl laurate, which is just slightly a chain link difference than the ones that you're including in the no- brainer group, for some reason that one's not a no-brainer just because we haven't looked at both the alcohol and the acid? I'm not saying you're wrong. I'm just asking is that what you mean? DR. MARKS: Correct, that's what Dr. Shank meant, I believe. DR. HILL: But we would be including everything in Table 2, right, because those have already been -- DR. ANSELL: I'm sorry. Isn't Table 2 materials which are pure in other reports? MS. FIUME: It is, but it could be the prerogative of the panel to include them here to have a complete group of all alkyl esters. DR. MARKS: And was that -- so that was included -- Table 2 was included in these structures and that table on page 53, is that right? MS. FIUME: No, those structures are not in Figure 1. DR. MARKS: Oh, hmm. So that's a new twist in terms of including -- huh. Would that strengthen the re-review? DR. HILL: I think it would because it facilitates read-across. There are a lot of these ingredients down in the lower half of page 54 that I think would be bumped up. But to me at least, I would go through and I certainly can also take it upon myself to check the ones I think do fall into the no- brainer rule of which I think there'd be quite a few, maybe the majority even. DR. MARKS: Hmm. DR. HELDRETH: Yeah, I would certainly think if we're looking at cetyl esters, then cetyl caprylate, which is going to be one of those cetyl esters, has to be a no-brainer. DR. MARKS: So for now should we proceed with saying yes, we want to reopen and then the next time we actually see a revised proposed list with an understanding of what we meant by no-brainers rather than us now going through 200 ingredients? I think that's going to be difficult. And then Ron Hill, you could actually as you think through it you can see which ones you would include also. Is that a reasonable way to proceed? We reopen and then see the list of ingredients the next time, and we use -- I think the best beginning points are page 54 and 55. Do you want to combine those ingredients in Table 2 into one whole report? Seems to make sense; they're all alkyl esters. We've done that before. DR. HILL: To me it makes very good sense. And if you look at it in that light, I think you could make some read-across on a large number of the ones in Table 1B. MS. FIUME: And those were included in your -- DR. HILL: I know. I know they were. MS. FIUME: And they were profiled for that purpose.

CIR Panel Book Page 23 Distributed for Comment Only -- Do Not Cite or Quote DR. HILL: I know, but in your data profile tables in the front, because you -- I mean, it's a beautiful job. I wrote thank you in huge letters at the top of at least one of these tables because you organized them in several different ways. The only thing I would have maybe done differently is to have put the ones that were previously reviewed right in the tables so that you could immediately -- see what I'm getting at? Instead of segregating all the ones -- this is for future reference -- MS. FIUME: If you look at Panel Book page 11, the previously reviewed alkyl esters -- you mean you wouldn't want them by themselves? You'd want them under the subcategories. DR. HILL: I wouldn't want them by themselves. I would have filtered them right in with the tables where they fit because then I can immediately look and say okay, here's isononyl, and we have isononyl esters, and we have repro tox, and we have sensitization -- then you know immediately. I hate to even suggest that given how much work went into this and how beautiful these tables are for use in read-across, but it would have helped me because I've been paging back and forth, whereas if you can look and see here are the X's, here are the missing spots. DR. MARKS: Okay, so I'm going to tomorrow second that we reopen the re-review of alkyl esters. And we'll see what the Belsito Team suggests to how to deal with all these ingredients, but I'm going to suggest we go to page 54 and 55 and that the top group where all the constituents have been reviewed as a no-brainer, that we add these previously reviewed safety assessments of alkyl esters in Table 2. Combine that and then we'll go back and look at the one constituent-reviewed section and none section and pull ingredients out of that to be included in this report. Does that sound reasonable? Ron, Ron, and Tom? Okay, good. Anything else on the alkyl esters?

CIR Panel Book Page 24 Report

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Safety Assessment of Alkyl Esters as Used in Cosmetics

Status: Draft Tentative Amended Report for CIR Expert Panel Review Release Date: August 17, 2012 Panel Meeting Date: September 10-11, 2012

The 2012 Cosmetic Ingredient Review Expert Panel members are: Chairman, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V. Belsito, M.D.; Ronald A. Hill, Ph.D.; Curtis D. Klaassen, Ph.D.; Daniel Liebler, Ph.D.; James G. Marks, Jr., M.D., Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR Director is F. Alan Andersen, Ph.D. This report was prepared by Monice M. Fiume, Senior Scientific Analyst/Writer, and Bart Heldreth, Ph.D., Chemist CIR.

Cosmetic Ingredient Review 1101 17th Street, NW, Suite 412 ♢ Washington, DC 20036-4702 ♢ ph 202.331.0651 ♢ fax 202.331.0088 ♢ [email protected]

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TABLE OF CONTENTS

Abstract (Draft) ...... 1 Introduction ...... 1 Chemistry ...... 1 Definition and Structure ...... 1 Methods of Manufacture ...... 1 Physical and Chemical Properties ...... 1 Impurities ...... 2 Use ...... 2 Cosmetic ...... 2 Non-Cosmetic ...... 2 Toxicokinetics ...... 3 Absorption, Distribution, Metabolism, and Excretion ...... 3 Dermal Penetration ...... 3 Penetration Enhancement ...... 3 Animal Toxicology ...... 4 Single Dose (Acute) Toxicity ...... 4 Dermal ...... 4 Oral ...... 4 Inhalation ...... 4 Repeated Dose Toxicity ...... 4 Oral ...... 4 Genotoxicity ...... 5 In Vitro ...... 5 In Vivo ...... 5 Carcinogenicity ...... 5 Irritation and Sensitization ...... 5 Dermal Irritation ...... 5 Non-Human ...... 5 Human ...... 6 Sensitization ...... 6 Non-Human ...... 6 Human ...... 7 Ocular Irritation ...... 7 Miscellaneous Effects ...... 7 Dermal Effects ...... 7 Summary ...... 7 Draft Discussion ...... 8 Draft Conclusion ...... 9 Figures ...... 11 Figure 1. Figures ordered by chain length, chemical structure ...... 11 Tables ...... 36 Table 1. Alkyl Esters Group (presented alphabetically) ...... 36 Table 2. Conclusions (year issued) and data summaries of previously reviewed alkyl esters ...... 37 Table 3. Alkyl Esters Group (grouped by whether individual constituents have been reviewed) ...... 44 Table 4. Constituent alcohols and acids with CIR conclusions ...... 46 Table 5. Definitions and functions ...... 46 Table 6. Methods of Manufacture ...... 55 Table 7. Chemical and physical properties...... 56 Table 8. Frequency and concentration of use according to duration and type of exposure ...... 65 Table 9. Ingredients not reported to be used ...... 76 Table 10. Examples of non-cosmetic uses ...... 77 References ...... 78

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ABSTRACT (DRAFT) The CIR Expert Panel assessed the safety of 254 alkyl esters for use in cosmetics, finding that these ingredients are safe in cosmetic formulations in the present practices of use and concentration when formulated to be non-irritating. The alkyl esters included in this report have a variety of reported functions in cosmetics, with skin conditioning agents being the most common function. The Panel reviewed available animal and clinical data in making its determination of safety, and when data gaps occurred, similarity in structure, properties, functions and uses of these ingredients allowed for extrapolation of the available toxicological data to assess the safety of the entire group. INTRODUCTION Cetyl esters, a synthetic wax composed of a mixture of esters of saturated fatty acids and fatty alcohols with carbon chain lengths between 14 and 18, is a cosmetic ingredient that was reviewed previously by the Cosmetic Ingredient Review (CIR) Expert Panel; in 1997, the Panel concluded that cetyl esters is safe as used in cosmetics.1 Cetyl esters is a member of a broader group of cosmetic ingredients, the alkyl esters, which consist of the reaction products of fatty acids and alcohols; these are now combined into one safety assessment. The 254 alkyl esters being reviewed in this safety assessment are presented alphabetically in Table 1. Although a number of these alkyl esters have been reviewed previously, they are included because they fit within this family of ingredients. The conclusions reached for the previously-reviewed ingredients (including cetyl esters) as well as a summary of the data included in those existing safety assessments are provided in Table 2. The profile of the data available for these alkyl esters includes single-dose and repeated-dose toxicity, toxicokinetics, reproductive and developmental toxicity, genotoxicity, carcinogenicity, dermal and ocular irritation, and sensitization and photosensitization studies supporting the safety of this class of cosmetic ingredient. In addition, the CIR has found safe many of the individual constituents that make up the alkyl esters, and the safety of the individual constituents is relevant to the safety the compound. Therefore, in Table 3, the ingredients are grouped by whether all, one, or none of the individual constituents have been found safe for use in cosmetics and in Table 4, a list of those individual components is provided. Please note that while the safety assessments on the individual constituents are relevant to the safety of the alkyl esters, the available data are well-documented in the existing CIR reports and will not be summarized here. Because the data from the existing safety assessments are included in Table 2, only new data will be included in the body of the safety assessment. CHEMISTRY Definition and Structure The ingredients in this review are alkyl esters. The core relationship between these ingredients is a carboxyl ester functional group flanked on both sides by alkyl chains. Some of these alkyl chains are straight and some are branched. The structures of the ingredients included in this report are depicted in Figure 1, which follows the text of this assessment. Definitions and structures for the ingredients included in this assessment are provided in Table 5. Methods of Manufacture Most of these alkyl esters are produced synthetically via classical Fischer type esterification methods (i.e., reaction of a carboxylic acid with an alcohol to produce a carboxylic ester), although the reaction may be promoted by acid or base catalysis, or by the use of an acid chloride (Figure 2).

O O + H3C OH HO CH3 H3C O CH3 Figure 2. Synthesis of capryl caprylate from capryl alcohol and caprylic acid

However, some of the natural source ingredients in this review may be produced by transesterification (i.e., trading a source material ester starting material for a new ester product). For example, the triglycerides (i.e., glyceryl tri-esters) in natural oils can be reacted with alcohols to produce new monoesters (and diglycerides, monoglycerides, and glycerin, depending on reaction stoichiometry). Available methods of manufacture are summarized in Table 6. Physical and Chemical Properties Alkyl esters are hydrophobic materials that range from oil, at the lowest molecular weights/shortest chain lengths, to waxy solids, at the highest molecular weights/longest chain lengths. Physical and chemical properties data are provided in Table 7.

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Impurities According to one report, in the synthesis of oleate esters using sodium alcoholates (base catalyst), methyl oleate was the major impurity.2 (The safety assessment of decyl and isodecyl oleate includes toxicity data on methyl oleate.3) USE Cosmetic The alkyl esters are reported to function in cosmetics mostly as skin conditioning agents.4 Some of the alkyl esters are reported to have additional functions. Most notably, isocetyl tallate is reported to also function as a plasticizer and solvent and tetradecylpropionates as a solvent. Isopropyl sorbate is reported to function as a preservative only, and not as a skin conditioning agent. The functions of each ingredient are provided in Table 5. The FDA collects information from manufacturers on the use of individual ingredients in cosmetics as a function of cosmetic product category in its Voluntary Cosmetic Registration Program (VCRP). VCRP data obtained from the FDA in 20125 and data received in response to a survey of the maximum reported use concentration by category conducted by the Personal Care Products Council (Council)6,7 indicate that 120 of the 254 alkyl esters named in this safety assessment are currently used in cosmetic formulations. Ethylhexyl palmitate has the most reported uses, 1298, followed by isopropyl myristate, 1149 reported uses, and isopropyl palmitate, 999 reported uses. (Cetyl esters is reported to be used in 452 cosmetic formulations.) The results of the concentration of use survey indicate that many of the alkyl esters are used at high concentrations in cosmetic formulations. Decyl oleate has the highest reported concentration of use, at up to 94% in tonics, dressings, and other hair grooming aids. Three ingredients were used at up to 78% in formulation, cetyl ethylhexanoate in eye make-up remover, ethylhexyl palmitate in body and hand preparations, and isopropyl myristate in tonics, dressings, and other hair grooming aids. Cetyl ethylhexanoate was used at up to 52% in lipstick formulations. In quite a few cases, reports of uses were received in the VCRP, but no concentration of use is available. For example, caprylyl caprylate is reported to be used in 11 formulations, but no use concentration data were reported. Additionally, there were quite a few instances in which no reported uses were received in the VCRP, but a use concentration was provided in the industry survey. For example, oleyl linoleate was not reported in the VCRP to be in use, but the industry survey indicated that it is used in leave-on formulations at up to 10-11%. It should be presumed in these cases, there is at least one use in every category for which a concentration is reported. The frequency and concentration of use data are provided in Table 8, and the ingredients not in use according to the VCRP and industry survey are listed in Table 9. Some alkyl esters are reported to be used on baby skin, to be applied to the eye area or mucous membranes, or could possibly be ingested. Additionally, some of the alkyl esters are used in cosmetic sprays and could possibly be inhaled. Examples of some of the highest concentrations of spray uses are up to 77% isopropyl myristate in hair sprays, 76% isopropyl palmitate in perfumes, 45% ethylhexyl palmitate in indoor tanning preparations, and 23% isopropyl myristate in deodorant formulations. In practice, 95% to 99% of the droplets/particles released from cosmetic sprays have aerodynamic equivalent diameters >10 µm, with propellant sprays yielding a greater fraction of droplets/particles <10 µm compared with pump sprays.8,9 Therefore, most droplets/particles incidentally inhaled from cosmetic sprays would be deposited in the nasopharyngeal and thoracic regions of the respiratory tract and would not be respirable (i.e., they would not enter the lungs) to any appreciable amount.10,11 There is some evidence indicating that deodorant spray products can release substantially larger fractions of particulates having aerodynamic equivalent diameters in the range considered to be respirable.11 However, the information is not sufficient to determine whether significantly greater lung exposures result from the use of deodorant sprays, compared to other cosmetic sprays. Ethylhexyl ethylhexanoate is listed in the European Union inventory of cosmetic ingredients,12 and according to the Euro- pean Chemical Substances Information System (ESIS), it has a reproductive risk classification of category 3, substances which cause concern, with risk phrase R63, possible risk of harm to the unborn child.13 Ethylhexyl ethylhexanoate is not restricted by the European Commission, but the Scientific Committee on Consumer Safety (SCCS) is of the opinion that “the use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic for reproduction, of category 1, 2 and 3, under Annex I to Directive 67/548/EEC shall be prohibited.”14 All other of the alkyl esters named in this report, with the following exceptions, are listed in the European Union inventory of cosmetic ingredients: behenyl olivate; cetyl myristoleate; and hexyldodecyl/octyldecyl hydroxystearate.12 Non-Cosmetic Isoamyl laurate and butyl stearate are approved as a direct food additive for use as a flavor substance adjuvant (21CFR172.515). Many of the alkyl esters are approved as indirect food additives as listed in the Code of Federal Regulations Title 21. Examples of non-cosmetic uses of some of the alkyl esters are provided in Table 10.

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TOXICOKINETICS Absorption, Distribution, Metabolism, and Excretion Cetyl Myristoleate Rats were fed chow containing 2% cetyl myristoleate or untreated feed for 2 h.15 No cety alcohol was found in the stomach, intestinal content, or mucosa in either group. (Additional details were not provided). Cetyl Oleate Groups of five male albino rats were fed a diet containing 20% cetyl oleate for 9 days; control groups were fed a fat-free diet or a diet containing 20% cottonseed oil.16 The animals were given 12 g of diet per day. The absorption of cetyl oleate was reported to be 75.3%. By day 2 of the study, the animals fed cetyl oleate developed seborrhea, which progressively increased with feeding. The animals were killed after the termination of dosing, and microscopic examination reported thickening and hyperemia of the intestinal wall. The exuded lipid was identified as cetyl oleate. The researchers stated that the absorbability and seborrhea suggested that cetyl oleate was not hydrolyzed in the gut. The researchers then dosed groups of six male rats with 2 g of cetyl oleate or an equal mixture of cetyl oleate + tributyrin by gavage, and the animals were fed a fat-free diet. Control animals were dosed with sucrose. The animals were fasted overnight on day 10 of dosing, and two animals were then killed. Two of the remaining animals were killed 1 h and two were killed 3 h after a final dose. Seborrhea was observed in both test groups; only cetyl oleate was recovered from the exuded lipid in both test groups. Intestinal weight was markedly increased in the cetyl oleate + tributyrin group. The free fatty acid content of the stomach 3 h after dosing and of the small intestine 1 and 3 h after dosing was increased in group dosed with cetyl oleate (only) when compared to controls. In the cetyl oleate + butyrin group, the free fatty acid content of the stomach was increased at both 1 and 3 h, and in the small intestine it was increased after 1 h. Dermal Penetration Isopropyl Myristate Isopropyl myristate, as a non-polar penetration enhancer, is largely retained in the stratum corneum.17 It was not detected in the receptor fluid of flow-through diffusion cells in in vitro skin permeation experiments using human epidermis (stratum corneum an dvialbe epidermis) and dermis (varying thickness). Isostearyl Isostearate Pre-deuterated isostearyl isostearate, 7 μl/cm2, was applied neat to a 2 cm x 8 cm site on the ventral forearm of 14 subjects for 3 h under non-occlusive conditions.18 The test site was tape-stripped 3 h after application, and attenuated total reflectance- Fourier transform infrared (ATF-FTIR) spectra measurements were determined. The researchers stated the most of the isostearyl isostearate was located at the surface of the stratum corneum. (The percent recovery of the amount applied was not specified.) Penetration Enhancement Isopropyl myristate is a non-polar penetration enhancer in pharmaceutical and cosmetic preparations, and an isopropyl alcohol-isopropyl myristate binary enhancer synergistically increased the transport of estradiol across a two-layer human epidermis in vitro.17 Isopropyl palmitate is reported to be used in topical formulations as a lipid layer penetration enhancer.19 The skin penetration of three lipophilic compounds (partition coefficient order: gliclazide>nimesulfide>oxaproxin) and one hydropholic compound (ribavirin) across excised rat abdominal skin after 2 h pre-treatment with 5-20% w/w isopropyl palmitate in ethanol was determined.20 All pre-treatment solutions produced a significant increase in the flux and permeation of all four compounds; the effectiveness was concentration-dependent. Skin penetration enhancement with isostearyl isostearate was evaluated in vitro using excised human abdominal skin by measuring the permeation of 5-fluorouracil through the skin after 6 h.21 Both isostearyl isostearate and the buffer control increased the rate of penetration of 5-fluorouracil, but isostearyl isostearate was not a penetration enhancer. The effect of alkyl esters on the penetration of indomethacin in vitro through excised hairless rat skin was examined.22 The permeation of 1% indomethacin from suspensions and from hydrogenated phospholipid gels containing cetyl caprylate, cetyl ethylhexanoate, isocetyl ethylhexanoate, stearyl ethylhexanoate, ethylhexyl palmitate, isocetyl palmitate, isocetyl isostearate, or isocetyl stearate was determined. The permeation rate of indomethacin from the esters increases with increased solubility of the drug in the ester. The solubility of indomethacin in liquid paraffin is very low, and there was no permeation of indomethacin from liquid paraffin after 10 h. Permeation from the isocetyl isostearate suspension, the alkyl ester indomethacin was least soluble in but with a 60-fold increase in solubility compared to liquid paraffin, was 3.8 μg/cm2 after 10 h. (Of the esters studied, indomethacin had the highest solubility in and permeation from ethylhexyl isononanoate, an alkyl ester previously reviewed by the CIR, with approximately 23 μg/cm2 permeating in 10 h.) Permeation rates (and solubility) were higher in gels formed by hydrogen phospholipid than from suspensions. In all cases, a linear relationship existed between the cumulative amounts of indomethacin that per- 3

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meated from any ester from 4 h to 10 h. In another study, the permeation rate of ketoprofen from an alkyl ester suspension through excised hairless rat skin was also proportional to its solubility in the suspension.23 ANIMAL TOXICOLOGY Single Dose (Acute) Toxicity Dermal Butyl Oleate The dermal toxicity of butyl oleate was determined in rabbits.24 A single dermal dose of 5 g/kg group butyl oleate was applied to 10 rabbits. Slight erythema was observed in 3 rabbits and moderate erythema in 7, and slight edema was observed in 6

rabbits and moderate edema in 3. None of the animals died, and the dermal LD50 of butyl oleate in rabbits was >5 g/kg. (Additional details were not provided.) Propylheptyl Caprylate Groups of 5 male and 5 female Wistar rats were dosed dermally with a single semi-occlusive application of 0 or 2000 mg/kg bw propylheptyl caprylate, applied neat.25 No irritation or treatment-related signs of toxicity were reported, and the dermal

LD50 of propylheptyl caprylate was >2 g/kg/bw. Ethylhexyl Laurate 26 The dermal LD50 of ethylhexyl laurate in rats was >3 g/kg bw. (Details were not provided.) Oral Butyl Oleate 24 A group of 10 rats were dosed orally with 5 g/kg butyl oleate. None of the animals died. The oral LD50 of butyl oleate in rats was >5 g/kg. Cetyl Myristoleate Five male and five female white rats were dosed orally with 5 g/kg cetyl myristoleate.15 There was no mortality, and the

LD50 was >5 g/kg. Propylheptyl Caprylate Six female Wistar rats were dosed orally with 2 g/kg bw propylheptyl caprylate in corn oil.25 All animals had hunched posture and piloerection for 6 h after dosing, but none of the animals died during the study. The oral LD50 of propylheptyl caprylate was >2 mg/kg bw. Ethylhexyl Laurate 26 The oral LD50 of ethylhexyl laurate in rats was >2 g/kg bw. (Details were not provided.) Isodecyl Laurate 27 The oral LD50 of isodecyl laurate in Wistar rats was >13 g/kg (>15 ml/kg). (Details were not provided.) Inhalation Ethylhexyl Laurate 26 The inhalation LC50 of ethylhexyl laurate in rats was >230 ppm. (Details were not provided.) Repeated Dose Toxicity Oral Propylheptyl Caprylate Groups of 10 male and 10 female rats were dosed daily by gavage with 0, 100, 300, or 1000 mg/kg bw/day propylheptyl caprylate in soybean oil for 90 days.25 No test-article related deaths occurred. No test-article related clinical signs of toxicity or changes in body weights or feed consumption, changes in the estrous cycle, or effects on sperm were observed, and there were no effects on any clinical chemistry or hematology parameters. A statistically significant decrease in the urinary pH values was considered test-article related. Absolute and relative liver weights were statistically significantly increased in animals of the high dose group. The change in urinary pH was attributed to the possibility that an acidic metabolite being eliminated in large doses, and the changes in liver weight were considered a non-specific adaptive change to the liver workload at the high does, therefore, the NOAEL was established as ≥1000 mg/mg bw/day propylheptyl caprylate. Ethylhexyl Laurate Male and female Sprague-Dawley rats, number per group not specified, were dosed with 0, 100, 300, or 1000 mg/kg bw ethylhexyl laurate once daily, 5 days/wk, by gavage for 28 days.26 The no-observable adverse-effect level (NOAEL) was 1000 mg/kg bw. (No additional details were provided.)

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Isodecyl Laurate Male Wistar rats, number per group not specified, were dosed orally with 500, 1500, or 4500 mg/kg/day isodecyl laurate, 6 days/wk, for 4 wks.27 No treatment related changes were observed at any dose level. (No additional details were provided.) GENOTOXICITY In Vitro Propylheptyl Caprylate The mutagenic potential of 0.31, 0.62, 1.25, 2.5, and 5.0 μl/plate propylheptyl caprylate was evaluated in an Ames test, with and without metabolic activation, using S. typhimurium strains TA1535, TA1573, TA98, TA100, and TA102.25 Dimethyl sulfoxide served as the vehicle. Propylheptyl caprylate was not mutagenic with or without metabolic activation. An in vitro mammalian chromosomal aberration assay was performed in Chinese hamster V79 lung fibroblasts with 22.4- 2480 μg/ml propylheptyl caprylate.25 The exposure time was 4 h with metabolic activation and ranged from 4-28 h without metabolic activation. Propylheptyl caprylate was not clastogenic to Chinese hamster V79 lung fibroblasts. Ethylhexyl Laurate Ethylhexyl laurate, tested at doses 8, 40, 200, 1000, and 5000 μg/plate, was not mutagenic in an Ames test performed in Salmonella typhimurium with and without metabolic activation.26 Isodecyl Laurate An Ames test was performed with 312-5000 μg/plate isodecyl laurate.27 Isodecyl laurate was not mutagenic towards S. typhimurium strains TA97, TA98, TA100, and TA102. (No additional details were provided.) In Vivo Ethylhexyl Laurate A mouse micronucleus test was performed in which male and female mice were dosed by gavage with 0, 1.25, 2.5, and 5.0 ml/kg ethylhexyl laurate.26 The animals were killed after 4, 48, or 72 h. Ethylhexyl laurate was not genotoxic in this assay. CARCINOGENICITY Published carcinogenicity data were not found. IRRITATION AND SENSITIZATION Dermal Irritation Non-Human Propylheptyl Caprylate Groups of 3 female SPF albino rabbits were used to determine the irritation potential of propylheptyl caprylate.25 The test material was applied as supplied for 4 h using a semi-occlusive patch; the amount applied was not specified. Two of the three rabbits had a mean score (calculated on the basis of the scores at 24, 48, and 72 h for each animal; max. value of 3) for erythema of 2, and one had a score of 2.33. For edema, the mean score for each animal was 0.33, 1, and 0. Dermal effects were observed at 7 days, but not 14 days, and propylheptyl caprylate was considered moderately irritating to rabbit skin. Isopropyl Palmitate A tolerance test was performed with a cream formulation consisting of carbomers, sorbitan oleate, paraffin liquid, propylene glycol, trometamol, purified water, and 10% isopropyl palmitate in 15 male hairless guinea pigs.19 The cream without isopropyl palmitate served as the negative control and a cream consisting of glyceryl stearate, PEG-100 stearate, cetostearyl alcohol, paraffin oil, propylene glycol, citric acid monohydrate, sodium citrate was used as a positive control. Open applications of 5 mg cream/cm2 were made twice daily to a 5 cm x 5 cm area on the each side of the dorsal trunk for 4 days. The test sites were scored immediately on scale of 0-4 prior to each application and at the end of the study. The cream with 10% isopropyl palmitate, but not without it, caused a moderate degree of irritation; the clinical scores as assess by area under the curve were 1.10, 7.25, and 9.10 for the negative control, the cream containing isopropyl palmitate, and the positive control, respectively. Ethylhexyl Laurate Using Organisation for Economic Co-operation and Development (OECD) Guideline 404 for “acute dermal irritation/corrosion” testing, ethylhexyl laurate was slightly irritating to rabbit skin.26 The European Commission classification was not irritating. Isodecyl Laurate The dermal irritation potential of 30% isodecyl laurate in liquid paraffin was determined.27 Doses of 500 mg were applied to two 4 cm x 4 cm intact and abraded test sites, and the test material was not irritating. It is unclear as to what species was

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tested. Only summary information was provided; the species/strain test states rat/Wistar, however the result stat that the chemical was not irritating to the skin of rabbits. No other details were provided. Cetyl Ethylhexanoate The dermal irritation of cetyl ethylhexanoate was determined using rabbits, guinea pigs, rats, and miniature swine.28 In rabbits, 0.1 g of undiluted cetyl ethylhexanoate was applied directly to a shaved 3 cm x 3 cm area on the back of six albino angora rabbits. n-Hexandecane was used as the control. A collar was used to prevent ingestion of the test substance. The test sites were scored for irritation 24 h after application. After scoring, the test site was clipped, the test article applied 30 min later, and the area was scored 48 h after application. Following this reading, all the hair on the dorsal surface was clipped and the animals were injected with Evan’s blue in physiological saline and then killed 1 h later. The total skin reaction score was assessed by evaluating erythema in live animals and the dilating rate, edema, and bluing rate in skin removed at the end of the study. The relative irritancy score for cetyl ethylhexanoate was 3/3, severely irritating to rabbit skin. A similar protocol and scoring was followed using groups of six male Hartley guinea pigs and six male Wistar rats, with the exception that the control was an untreated site. Again, the dose tested was 0.1 g cetyl ethylhexanoate applied to a 3 cm x 3 cm area of shaved skin. The relative irritancy score for cetyl ethylhexanoate was 2/3, moderately irritating, in the guinea pig and 1/3, mildly irritating, in the rat. Using miniature swine, 0.05 g cetyl ethylhexanoate was applied to the clipped skin of 6 animals for 48 h using a 15 mm occlusive patch. The test site was then scored as described above. The relative irritancy score for cetyl ethylhexanoate was 0/3 in miniature swine, non-irritating. Human Propylheptyl Caprylate The dermal irritation of 10, 25, or 50% propylheptyl caprylate in mineral oil and 100% propylheptyl caprylate was evaluated in 22 subjects.25 Approximately 0.2 ml of each test material was applied using a 1.9 cm x 1.9 cm occlusive patch, delivering a does of 47.6 mg/cm2 undiluted propylheptyl caprylate, for 48 h. No dermal effects were noted at any test concentration, and propylheptyl caprylate was non-irritating following a single 48-h occlusive application. Isopropyl Myristate A total of 244 subjects with suspected contact dermatitis were patch tested over a 3 yr period with a cosmetic series that included isopropyl myristate.29 There were three positive responses to isopropyl myristate. Isopropyl Palmitate The irritation potential of a cream containing 10% isopropyl palmitate (described earlier) was evaluated in a human chamber scarification test in 20 subjects.19 The test material (0.1 ml) was applied to the abraded skin of the volar forearm under a 23-h patch daily for 3 days. Paraffin oil was applied as the negative control and 0.5% aq. sodium lauryl sulfate was used as the positive control. Irritation was scored on a scale of 0-4 immediately prior to patch application and 1 h after removal of the final patch. The clinical score for the test material was greater than that of the negative control (2.71 vs. 2.17), but the difference was not statistically significant and the test substance with 10% isopropyl palmitate was well tolerated. The clinical score of the positive control was 5.29. Ethylhexyl Laurate An open epicutaneous test was performed in 10 subjects to determine the irritation potential of 50% and undiluted 2- ethylhexyl esters of C8-14 fatty acids.26 The test substance was applied for 60 min, and was not irritating at either concentration. (Additional details were not provided.) In closed epicutaneous test using 20 subjects, 25, 50,and 100% 2-ethylhexyl esters of C8-14 fatty acids was applied for 24 h using an occlusive patch.26 No reactions were observed at concentrations of 25 or 50%. However, with undiluted test article, slight erythema, 3 incidences of moderate edema, and 1 of slight edema were observed. (Additional details were not provided.) Cetyl Ethylhexanoate The dermal irritation of cetyl ethylhexanoate was evaluated by applying 0.05 g of undiluted test article on a 15 mm patch to 50 male subjects.28 The patches were removed after 48 h, and the test sites scored 30 min later. Undiluted cetyl ethylhexanoate was mildly irritating (defined as producing 10-40% positive reactions) to humans skin. (Additional details were not provided.) Sensitization Non-Human Propylheptyl Caprylate The sensitization potential of 0, 2, 10, and 50% propylheptyl caprylate in corn oil was evaluated in a mouse local lymph node assay.25 A lymphocyte proliferative response was not induced, indicating that propylheptyl caprylate is not a sensitizer.

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Ethylhexyl Laurate A guinea pig maximization test was performed to determine the sensitization potential of ethylhexyl laurate.26 The concentrations used for intradermal and topical induction were 0.5 and 40%, respectively, and the challenge concentration was 20%. Ethylhexyl laurate was not a sensitizer. (Additional details were not provided.) Isodecyl Laurate A GPMT conducted to determine the sensitization potential of isodecyl laurate.27 It was reported that isodecyl laurate was not a sensitizer in guinea pigs, but no details of the study were provided. Human Butyl Oleate The sensitization potential of butyl oleate was determined in a maximization study in 9 male and 16 female subjects.30 An occlusive patch was applied to the volar forearm of all subjects for 5 alternate-day 48-h periods. Because a preliminary 48- hour occlusive patch did not cause irritation, an occlusive patch of 5% aq. sodium lauryl sulfate was applied prior to patching with butyl oleate. The challenge sites were scored upon patch removal and 24 h later. All challenge scores were 0, and butyl oleate was not a sensitizer. (Additional details were not provided.) Ocular Irritation Propylheptyl Caprylate The ocular irritation potential of propylheptyl caprylate was evaluated in 3 female rabbits.25 Slight conjunctival irritation was observed in all animals 1 h after instillation, and the irritation had increased to a more diffuse response in one animal at 24 h after instillation. All effects subsided within 72 h for two of the animals and by 7 days in the third animal. Propylheptyl caprylate was considered slightly irritating to rabbit eyes. Ethylhexyl Laurate Ethylhexyl laurate was not irritating to rabbit eyes.26 (Details not provided.) Isodecyl Laurate A study was conducted in New Zealand White rabbits to determine the ocular irritation potential of 10% isodecyl laurate in liquid paraffin.27 No significant treatment-related ocular lesions were observed. (No additional details were provided.) MISCELLANEOUS EFFECTS Dermal Effects Isostearyl Isostearate A determination of skin surface water loss, measured using a plastic occlusion stress test, indicated that isostearyl isostearate improved the stratum corneum water permeability barrier function.31 The researchers hypothesize that the improvement was due to effects on stratum corneum lipid phase behavior. SUMMARY Cetyl esters has been reviewed previously by the Cosmetic Ingredient Review (CIR) Expert Panel, and in 1997 the Panel concluded that cetyl esters was safe as used in cosmetics. Cetyl esters is a member of a broader group of 254 cosmetic ingredients, the alkyl esters. These ingredients consist of the reaction products of fatty acids and alcohols, and the core relationship between these ingredients is a carboxyl ester functional group flanked on both sides by alkyl chains. Some of these alkyl chains are straight and some are branched. Although some of the alkyl esters have been reviewed previously, all are being included as ingredients in this safety assessment due to their structural and functional similarity. Most of the ingredients included in the safety assessment are reported to function in cosmetics as skin conditioning agents; the most notable difference is isopropyl sorbate, which is reported to function as a preservative only. Most of these alkyl esters are produced synthetically via classical Fischer type esterification methods. However, some of the natural source ingredients in this review may be produced by transesterification. Alkyl esters are hydrophobic materials that range from oils at the lowest molecular weights/shortest chain lengths to waxy solids at the highest molecular weights/longest chain lengths. VCRP and industry data indicate that 120 of the 254 alkyl esters named in this safety assessment are currently used in cosmetic formulations. Ethyhexyl palmitate has the most reported uses, 1298, followed by isopropyl myristate, 1149 reported uses, and isopropyl palmitate, 999 reported uses. Decyl oleate has the highest reported concentration of use, up to 94%, and cetyl ethylhexanoate, ethylhexyl palmitate, and isopropyl myristate are used at up to 78% in formulation. Isoamyl laurate and butyl stearate are approved as a direct food additives and a number of the alkyl esters are approved as indirect food additives. In rats fed a diet containing 20% cetyl oleate, absorption of cetyl oleate was reported to be 75.3%. All the animals developed seborrhea. The absorbability and seborrhea suggested that cetyl oleate was not hydrolyzed in the gut. 7

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Isopropyl palmitate is reported to be used in topical formulations as a lipid layer penetration enhancer. Isostearyl isostearate increased the rate of penetration of fluorouracil through excised skin, but it was not a penetration enhancer. Alkyl esters tended to increase the permeation rate of indomethacin and ketoprofen; the increase occurred due to increased solubility.

The dermal LD50 of butyl oleate in rabbits was >5 g/kg, and the dermal LD50 in rats of propylheptyl caprylate and ethylhexyl laurate and was >2 and >3 g/kg/bw, respectively. The oral LD50 in rats was >5 g/kg for butyl oleate and for cetyl myristoleate, >2 g/kg for propylheptyl caprylate and ethylhexyl laurate, >13 g/kg for isodecyl oleate, and >64 cc/kg for isopropyl linoleate. The inhalation LC50 of ethylhexyl laurate in rats was >230 ppm. In repeated dose studies in rats, toxic effects were not observed with oral administration of up to 1000 mg/kg ethylhexyl laurate or 4500 mg/kg/day isodecyl laurate for 4 wks or with up to 1000 mg/kg bw/day propylheptyl caprylate for 90 days. Propylheptyl caprylate was not mutagenic in an Ames assay (≤5.0 μl/plate) or clastogenic in an in vitro mammalian chromosomal aberration assay (≤2480 μg/ml). Ethylhexyl laurate and isodecyl laurate were not mutagenic towards S. typhimurium in an Ames assay at doses of ≤5000 μg/plate, and ethylhexyl laurate, ≤5.0 ml/kg, was not genotoxic in a mouse micronucleus test. Mixed results were reported in irritation testing in non-human testing with some alkyl esters. In rabbits, propylheptyl caprylate was moderately irritating and ethylhexyl laurate was not irritating. A formulation containing 10% isopropyl palmitate was moderately irritating in male hairless guinea pigs. Undiluted cetyl ethylhexanoate was severely irritating to rabbit skin, moderately irritating to guinea pig skin, mildly irritating to rat skin, and non-irritating to the skin of miniature swine. In a mouse local lymph node assay, propylheptyl caprylate did not induce a lymphocyte proliferative response, indicating that it is not a sensitizer. Ethylhexyl laurate and isodecyl laurate were not sensitizers in a guinea pig maximization test. Mixed irritation results were also observed in human studies. Propylheptyl caprylate, which was moderately irritating in rabbit skin, was not irritating to human skin when applied for 48-h using an occlusive patch. Patch testing with isopropyl myristate resulted in 3/244 positive reactions in subjects with suspected contact dermatitis. A formulation containing 10% isopropyl palmitate, which was moderately irritating to guinea pig skin, was well tolerated in a human chamber scarification test. Undiluted and 50% 2-ethylhexyl esters of C8-14 fatty acids applied openly for 60 min and 25 and 50% applied with an occlusive 24-h patch were not irritating, but undiluted 2-ethylheyxl esters of C8-14 fatty acids produced slight erythema and moderate edema when applied with an occlusive 24-h patch. A 48-h patch with undiluted cetyl ethylhexanoate produced mild irritation. Butyl oleate was not a sensitizer in humans. Ocular irritation studies were performed using rabbits. Cetyl esters, 60-65%, ethylhexyl laurate, 10% isodecyl laurate in liquid paraffin, and 10% isopropyl laurate in corn oil were not irritating to rabbit eyes and undiluted and 10% aq. isopropyl linoleate and propylheptyl caprylate was slightly irritating to rabbit eyes. DRAFT DISCUSSION The discussion for the report will be developed at the meeting. Some of the following discussion items might be included. Additional discussion points may be added; some that are included below may be deleted or changed. The question of whether a re-review of cetyl esters, an ingredient found safe as used by the Panel in 1997, was warranted was brought to the CIR Expert Panel. Although there were no new data to indicate a re-review, the inclusion of additional ingredients did warrant a re-review. As a result, the safety of the Alkyl Esters family is being assessed for cosmetic use; these ingredients consist of the reaction products of fatty acids and alcohols. Although there are data gaps, the similar chemical structures, physicochemical properties, functions, and concentrations in cosmetics allow grouping these ingredients together and interpolating the available toxicological data to support the safety of the entire group. The available data on many of the ingredients, especially the previously reviewed ingredients, and on some of the constituent alcohols and acids are sufficient, and similar structural activity relationships, biologic functions, and cosmetic product usage suggest that the available data may be extrapolated to support the safety of the entire group. For example, a concern was expressed regarding the extent of dermal absorption for certain long-chain, branched alkyl esters because of a lack of information on dermal absorption and metabolism. The consensus of the Panel was that because dermal penetration of long chain alcohols is likely to be low, and the dermal penetration for alkyl esters is likely to be even lower, inferring toxicity characteristics from ingredients where toxicity data were available was appropriate. The Expert Panel recognized that some of the alkyl esters can enhance the penetration of other ingredients through the skin. The Panel cautioned that care should be taken in formulating cosmetic products that may contain these ingredients in combination with any ingredients whose safety was based on their lack of dermal absorption data, or when dermal absorption was a concern. The Panel acknowledged that some of the alkyl esters may be plant-derived or animals-derived. The Panel expressed concern regarding pesticide residues and heavy metal that may be present in botanical ingredients. They stressed the cosmetics industry should continue to use the necessary procedures to limit these impurities in the ingredient before blending them into

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cosmetic formulations. Additionally, the Panel considered the dangers inherent in using animal-derived ingredients, namely the transmission of infectious agents. While tallow may be used in the manufacture of some ingredients in this safety assessment and is clearly animal-derived, the Expert Panel notes that tallow is highly processed and tallow derivatives even more so. The Panel agrees with determinations by the U.S. FDA that tallow derivatives are not risk materials for transmission of infectious agents. It is known that 2-ethylhexanoic acid, a possible metabolite of some of the alkyl esters, e.g. cetearyl ethylhexanoate, is a liver and developmental toxicant in animal studies at high dose levels, and it has been postulated that the maternal liver toxicity could begin a cascade of effects that includes metallothionein (MT) induction, zinc accumulation in the liver due to MT binding, and a resulting zinc deficiency in the developing embryo. The Panel found that results of testing with di-2-ethylhexyl terephthalate (a 2-ethylhexanoic acid precursor used as a model for exposure without liver toxicity, etc,) suggested that the process of metabolic conversion results in a time course that allows clearance of 2-ethylhexanoic acid before sufficient levels can arise to produce toxicity; this outcome, in addition to the fact that cetearyl ethylhexanoate would have to pass through the stratum corneum before entering the blood stream, precluded the risk of developmental toxicity The Expert Panel was also concerned that the potential exists for dermal irritation with the use of products formulated using some of the alkyl esters. It was mostly because of the potential for irritation that isopropyl linoleate was found to have insufficient data in the 1992 safety assessment. The Expert Panel specified that products must be formulated to be non-irritating. Consequently, with the use of this caveat, the data on isopropyl linoleate are now sufficient to determine safety. Because these ingredients were reported to be used in products that may be aerosolized, and some at quite high concentrations, e.g., 77% isopropyl myristate in hair sprays, 76% isopropyl palmitate in perfumes, 45% ethylhexyl palmitate in indoor tanning preparations, and 23% isopropyl myristate in deodorant formulations, the Panel discussed the issue of incidental inhalation exposure. The Panel considered that the preponderance of the data indicate that the alkyl esters are not systemic toxicants and incidental inhalation exposures to the ingredients used in aerosolized cosmetic products would not cause adverse health effects. The Panel noted that 95% – 99% of droplets/ particles produced in cosmetic aerosols would not be respirable to any appreciable amount. However, the potential for inhalation toxicity is not limited to respirable droplets/particles deposited in the lungs. In principle, inhaled droplets/particles deposited in the nasopharyngeal and thoracic regions of the respiratory tract may cause toxic effects depending on their chemical and other properties. However, these ingredients are large macromolecules and most are insoluble in water, which supports the view that they are unlikely to be absorbed or cause local effects in the respiratory tract. Coupled with the small actual exposure in the breathing zone and the concentrations at which the ingredients are used, the available information indicates that incidental inhalation would not be a significant route of exposure that might lead to local respiratory or systemic effects. A detailed discussion and summary of the Panel’s approach to evaluating incidental inhalation exposures to ingredients in cosmetic products that may be aerosolized is available at http://www.cir-safety.org/cir-findings. DRAFT CONCLUSION The CIR Expert Panel concluded that the alkyl esters, listed below, are safe in the present practices of use and concentration described in this safety assessment when formulated to be non-irritating. Were ingredients in this group not in current use (as indicated by *) to be used in the future, the expectation is that they would be used in product categories and at concentrations comparable to others in this group.

Arachidyl Behenate C10-40 Isoalkyl Acid Octyldodecanol Esters* Cetearyl Olivate Arachidyl Erucate* C12-13 Alkyl Ethylhexanoate Cetearyl Palmate* Arachidyl Propionate C12-15 Alkyl Ethylhexanoate Cetearyl Palmitate* Batyl Isostearate* C14-18 Alkyl Ethylhexanoate* Cetearyl Rice Branate* Batyl Stearate* C14-30 Alkyl Beeswax* Cetearyl Stearate Behenyl Beeswax C16-36 Alkyl Stearate* Cetyl Babassuate Behenyl Behenate C18-38 Alkyl Beeswax* Cetyl Behenate* Behenyl Erucate C18-38 Alkyl C24-54 Acid Ester* Cetyl Caprate Behenyl Isostearate* C20-40 Alkyl Behenate* Cetyl Caprylate Behenyl Olivate C20-40 Alkyl Stearate Cetyl Dimethyloctanoate* Behenyl/Isostearyl Beeswax* C30-50 Alkyl Beeswax* Cetyl Esters Butyl Avocadate C30-50 Alkyl Stearate* Cetyl Ethylhexanoate Butyl Babassuate* C32-36 Isoalkyl Stearate* Cetyl Isononanoate* Butyl Isostearate* C40-60 Alkyl Stearate* Cetyl Laurate Butyl Myristate C4-5 Isoalkyl Cocoate* Cetyl Myristate Butyl Oleate* Caprylyl Butyrate* Cetyl Myristoleate* Butyl Stearate Caprylyl Caprylate Cetyl Oleate* Butyloctyl Beeswax* Caprylyl Eicosenoate Cetyl Palmitate Butyloctyl Behenate* Cetearyl Behenate Cetyl Ricinoleate Butyloctyl Candelillate* Cetearyl Candelillate Cetyl Stearate Butyloctyl Cetearate* Cetearyl Ethylhexanoate Cetyl Tallowate Butyloctyl Oleate* Cetearyl Isononanoate Chimyl Isostearate* Butyloctyl Palmitate* Cetearyl Nonanoate* Chimyl Stearate*

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Coco-Caprylate Isocetyl Isodecanoate* Lauryl Oleate/ Coco-Caprylate/Caprate Isocetyl Isostearate* Lauryl Palmitate Coco-Rapeseedate* Isocetyl Laurate* Lauryl Stearate/ Decyl Castorate* Isocetyl Myristate Lignoceryl Erucate* Decyl Cocoate Isocetyl Palmitate Myristyl Ethylhexanoate* Decyl Isostearate* Isocetyl Stearate Myristyl Isostearate* Decyl Jojobate* Isodecyl Cocoate Myristyl Laurate Decyl Laurate* Isodecyl Ethylhexanoate* Myristyl Myristate Decyl Myristate* Isodecyl Hydroxystearate* Myristyl Neopentanoate Decyl Oleate Isodecyl Isononanoate Myristyl Stearate Decyl Olivate Isodecyl Laurate Octyldecyl Oleate* Decyl Palmitate* Isodecyl Myristate Octyldodecyl Avocadoate* Decyltetradecyl Cetearate* Isodecyl Neopentanoate Octyldodecyl Beeswax* Decyltetradecyl Ethylhexanoate* Isodecyl Oleate Octyldodecyl Behenate* Erucyl Arachidate* Isodecyl Palmitate* Octyldodecyl Cocoate* Erucyl Erucate* Isodecyl Stearate* Octyldodecyl Erucate Erucyl Oleate* Isohexyl Caprate Octyldodecyl Ethylhexanoate* Ethylhexyl Adipate/Palmitate/Stearate* Isohexyl Laurate* Octyldodecyl Hydroxystearate* Ethylhexyl C10-40 Isoalkyl Acidate* Isohexyl Neopentanoate* Octyldodecyl Isostearate Ethylhexyl Cocoate Isohexyl Palmitate* Octyldodecyl Meadowfoamate* Ethylhexyl Ethylhexanoate Isolauryl Behenate* Octyldodecyl Myristate Ethylhexyl Hydroxystearate Isononyl Isononanoate Octyldodecyl Neodecanoate* Ethylhexyl Isononanoate Isooctyl Caprylate/Caprate* Octyldodecyl Neopentanoate Ethylhexyl Isopalmitate Isooctyl Tallate* Octyldodecyl Octyldodecanoate Ethylhexyl Isostearate Isopropyl Isostearate Octyldodecyl Oleate* Ethylhexyl Laurate Isopropyl Arachidate* Octyldodecyl Olivate Ethylhexyl Myristate Isopropyl Avocadate* Octyldodecyl Ricinoleate Ethylhexyl Neopentanoate* Isopropyl Babassuate* Octyldodecyl Safflowerate* Ethylhexyl Oleate* Isopropyl Behenate* Octyldodecyl Stearate Ethylhexyl Olivate Isopropyl Hydroxystearate Oleyl Arachidate* Ethylhexyl Palmitate Isopropyl Jojobate Oleyl Erucate Ethylhexyl Pelargonate Isopropyl Laurate* Oleyl Linoleate Ethylhexyl Stearate Isopropyl Linoleate Oleyl Myristate* Heptyl Undecylenate Isopropyl Myristate Oleyl Oleate Heptylundecyl Hydroxystearate Isopropyl Oleate* Oleyl Stearate* Hexyl Isostearate Isopropyl Palmitate Propylheptyl Caprylate Hexyl Laurate Isopropyl Ricinoleate Stearyl Beeswax Hexyldecyl Ethylhexanoate* Isopropyl Sorbate* Stearyl Behenate* Hexyldecyl Hexyldecanoate* Isopropyl Stearate Stearyl Caprylate Hexyldecyl Isostearate Isopropyl Tallowate* Stearyl Erucate* Hexyldecyl Laurate Isostearyl Avocadate Stearyl Ethylhexanoate Hexyldecyl Oleate* Isostearyl Behenate Stearyl Heptanoate Hexyldecyl Palmitate* Isostearyl Erucate* Stearyl Linoleate* Hexyldecyl Stearate Isostearyl Ethylhexanoate* Stearyl Olivate Hexyldodecyl/Octyldecyl Hydroxystearate* Isostearyl Hydroxystearate Stearyl Palmitate Hydrogenated Castor Oil Behenyl Esters* Isostearyl Isononanoate Stearyl Stearate Hydrogenated Castor Oil Cetyl Esters * Isostearyl Isostearate Tetradecyleicosyl Stearate* Hydrogenated Castor Oil Stearyl Esters* Isostearyl Laurate Tetradecyloctadecyl Behenate* Hydrogenated Ethylhexyl Olivate Isostearyl Linoleate Tetradecyloctadecyl Hexyldecanoate* Hydrogenated Ethylhexyl Sesamate* Isostearyl Myristate Tetradecyloctadecyl Myristate* Hydrogenated Isocetyl Olivate* Isostearyl Neopentanoate Tetradecyloctadecyl Stearate Hydrogenated Isopropyl Jojobate* Isostearyl Palmitate Tetradecylpropionates* Hydroxycetyl Isostearate* Isotridecyl Isononanoate Tridecyl Behenate* Hydroxyoctacosanyl Hydroxystearate Isotridecyl Laurate* Tridecyl Cocoate* Isoamyl Laurate Isotridecyl Myristate* Tridecyl Erucate* Isobutyl Myristate* Isotridecyl Stearate Tridecyl Ethylhexanoate Isobutyl Palmitate* Lauryl Behenate* Tridecyl Isononanoate Isobutyl Perlargonate* Lauryl Cocoate* Tridecyl Laurate* Isobutyl Stearate* Lauryl Ethylhexanoate* Tridecyl Myristate* Isobutyl Tallowate* Lauryl Isostearate* Tridecyl Neopentanoate Isocetyl Behenate* Lauryl Laurate Tridecyl Stearate Isocetyl Ethylhexanoate Lauryl Myristate*

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FIGURES Figure 1. Figures ordered by chain length, chemical structure

Structures, straight chain alkyl ingredients by total length 1. Cetyl Esters

2. Caprylyl Butyrate

3. Caprylyl Caprylate

4. Hexyl Laurate

5. Butyl Myristate

6. Decyl Laurate

7. Butyl Stearate

8. Arachidyl Propionate

9. Stearyl Caprylate

10. Decyl Myristate

11. Lauryl Laurate

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12. Cetyl Caprylate

13. Tridecyl Laurate

14. Cetyl Caprate

15. Decyl Palmitate

16. Lauryl Myristate

17. Myristyl Laurate

18. Tridecyl Myristate

19. Myristyl Myristate

20. Cetyl Laurate

21. Lauryl Palmitate

22. Lauryl Stearate

23. Cetyl Myristate

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24. Tridecyl Stearate

25. Myristyl Stearate

26. Cetyl Palmitate

27. Stearyl Palmitate

28. Cetyl Stearate

29. Lauryl Behenate

30. Stearyl Heptanoate

31. Tridecyl Behenate

32. Stearyl Stearate

33. Cetyl Behenate

34. Stearyl Behenate

35. Arachidyl Behenate 13

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36. Behenyl Behenate

Unsaturated Straightchain 37. Heptyl Undecylenate

38. Butyl Oleate

39. Caprylyl Eicosenoate

40. Decyl Oleate

41. Cetyl Myristoleate

42. Lauryl Oleate

43. Oleyl Myristate

44. Cetyl Oleate

45. Tridecyl Erucate

46. Oleyl Stearate

47. Stearyl Linoleate

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48. Oleyl Oleate

49. Oleyl Linoleate

50. Oleyl Arachidate

51. Stearyl Erucate

52. Erucyl Oleate

53. Oleyl Erucate

54. Arachidyl Erucate

55. Behenyl Erucate

56. Erucyl Arachidate

57. Erucyl Erucate

58. Lignoceryl Erucate

Branched, by longest length 59. Isohexyl Neopentanoate (one example of an “iso”)

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60. Isopropyl Sorbate

61. Ethylhexyl Neopentanoate

62. Isobutyl Pelargonate

63. Isodecyl Neopentanoate (one example of an “iso”)

64. Ethylhexyl Ethylhexanoate

65. Ethylhexyl Isononanoate (one example of an “iso”)

66. Isohexyl Caprate (one example of an “iso”)

67. Isopropyl Laurate

68. Tridecyl Neopentanoate

69. Octyldodecyl Neopentanoate

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70. Isodecyl Ethylhexanoate (one example of an “iso”)

71. Isononyl Isononanoate (one example of an “iso”)

72. Ethylhexyl Pelargonate

73. Propylheptyl Caprylate

74. Isopropyl Myristate

75. Myristyl Neopentanoate

O CH3 H3C O CH3 H3C

76. Isobutyl Myristate

77. Isohexyl Laurate (one example of an “iso”)

78. Isoamyl Laurate

79. Hexyldecyl Ethylhexanoate

80. Isodecyl Isononanoate (one example of an “iso”)

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81. Lauryl Ethylhexanoate

82. Isopropyl Palmitate

83. Ethylhexyl Laurate

84. Tridecyl Ethylhexanoate

85. Isostearyl Neopentanoate (one example of an “iso”)

86. Isotridecyl Isononanoate

87. Ethylhexyl Myristate

88. Octyldodecyl Ethylhexanoate

89. Octyldodecyl Neodecanoate

90. Isobutyl Palmitate

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91. Isopropyl Linoleate

92. Isopropyl Oleate

93. Isopropyl Isostearate (one example of an “iso”)

94. Myristyl Ethylhexanoate

95. Isopropyl Stearate

96. Hexyldecyl Hexyldecanoate

97. Decyltetradecyl Ethylhexanoate

98. Isodecyl Laurate (one example of an “iso”)

99. Isohexyl Palmitate (one example of an “iso”)

100. Isobutyl Stearate

101. Tridecyl Isononanoate

O CH3 H3C O CH3

102. Butyl Isostearate (one example of an “iso”) 19

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103. Ethylhexyl Isopalmitate (one example of an “iso”)

104. Isocetyl Ethylhexanoate (one example of an “iso”)

105. Ethylhexyl Palmitate

106. Cetyl Ethylhexanoate

107. Isopropyl Arachidate (one example of an “iso”)

108. Hexyldecyl Laurate

109. Isodecyl Myristate (one example of an “iso”)

110. Isostearyl Ethylhexanoate (one example of an “iso”)

111. Hexyl Isostearate (one example of an “iso”)

112. Ethylhexyl Isostearate (one example of an “iso”)

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113. Cetyl Isononanoate

114. Isotridecyl Laurate (one example of an “iso”)

115. Stearyl Ethylhexanoate

116. Ethylhexyl Stearate

117. Octyldodecyl Octyldodecanoate

118. Octyldodecyl Myristate

119. Butyloctyl Palmitate

120. Ethylhexyl Oleate

121. Cetyl Dimethyloctanoate

122. Isopropyl Behenate (one example of an “iso”)

123. Isocetyl Isodecanoate (one example of an “iso”)

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124. Isostearyl Isononanoate (one example of an “iso”)

125. Isodecyl Palmitate (one example of an “iso”)

126. Isotridecyl Myristate (one example of an “iso”)

127. Butyloctyl Oleate

128. Hexyldecyl Palmitate

129. Isodecyl Stearate (one example of an “iso”)

O H3C O CH3 CH3

130. Hexyldecyl Isostearate (one example of an “iso”)

131. Decyl Isostearate (one example of an “iso”)

132. Isodecyl Oleate (one example of an “iso”)

133. Isocetyl Laurate (one example of an “iso”)

134. Tetradecyloctadecyl Hexyldecanoate

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135. Hexyldecyl Oleate

136. Hexyldecyl Stearate

137. Octyldecyl Oleate

138. Isocetyl Myristate (one example of an “iso”)

139. Octyldodecyl Isostearate (one example of an “iso”)

140. Isostearyl Laurate (one example of an “iso”)

141. Lauryl Isostearate (one example of an “iso”)

142. Isotridecyl Stearate (one example of an “iso”)

143. Butyloctyl Behenate

144. Octyldodecyl Stearate

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145. Octyldodecyl Oleate

146. Isostearyl Myristate (one example of an “iso”)

147. Isocetyl Palmitate (one example of an “iso”)

148. Tetradecyloctadecyl Myristate

149. Isocetyl Isostearate (one example of an “iso”)

150. Myristyl Isostearate (one example of an “iso”)

151. Isostearyl Palmitate (one example of an “iso”)

152. Isocetyl Stearate (one example of an “iso”)

153. Isolauryl Behenate (one example of an “iso”)

154. Octyldodecyl Behenate

155. Isostearyl Isostearate (one example of an “iso”)

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156. Octyldodecyl Erucate

157. Isostearyl Linoleate (one example of an “iso”)

158. Tetradecyleicosyl Stearate

159. Tetradecyloctadecyl Stearate

160. Isocetyl Behenate (one example of an “iso”)

161. Behenyl Isostearate (one example of an “iso”)

162. Isostearyl Behenate (one example of an “iso”)

163. Isostearyl Erucate (one example of an “iso”)

O H C CH 3 O 3 CH3

164. Tetradecyloctadecyl Behenate

Hydroxy-substituted, by longest length 165. Isopropyl Hydroxystearate (one example of an “iso”)

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166. Isopropyl Ricinoleate

167. Ethylhexyl Hydroxystearate

168. Isodecyl Hydroxystearate (one example of an “iso”)

169. Heptylundecyl Hydroxystearate

170. Octyldodecyl Ricinoleate

O OH CH3 H3C O

H3C

171. Octyldodecyl Hydroxystearate

172. Cetyl Ricinoleate

173. Hydroxycetyl Isostearate (one example of an “iso”)

174. Isostearyl Hydroxystearate (one example of an “iso”)

175. Chimyl Isostearate (one example of an “iso”)

176. Chimyl Stearate

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177. Batyl Isostearate (one example of an “iso”)

178. Batyl Stearate

179. Hydroxyoctacosanyl Hydroxystearate

Mixtures (alphabetical) 180. Behenyl Beeswax

181. Behenyl/Isostearyl Beeswax (one example of an “iso”)

182. Behenyl Olivate

183. Butyl Avocadate

184. Butyl Babassuate

185. Butyloctyl Beeswax

186. Butyloctyl Candelillate

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187. Butyloctyl Cetearate

188. C12‐13 Alkyl Ethylhexanoate

189. C12‐15 Alkyl Ethylhexanoate

190. C14‐18 Alkyl Ethylhexanoate

191. C14‐30 Alkyl Beeswax

192. C18‐38 Alkyl Beeswax

193. C30‐50 Alkyl Beeswax

194. C20‐40 Alkyl Behenate

195. C18‐38 Alkyl C24‐54 Acid Ester

196. C16‐36 Alkyl Stearate

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197. C20‐40 Alkyl Stearate

198. C30‐50 Alkyl Stearate

199. C40‐60 Alkyl Stearate

200. Cetearyl Behenate

201. Cetearyl Candelillate

202. Cetearyl Ethylhexanoate

203. Cetearyl Isononanoate (one example of an “iso”)

204. Cetearyl Nonanoate

205. Cetearyl Olivate

206. Cetearyl Palmate

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207. Cetearyl Palmitate

208. Cetearyl Rice Branate

209. Cetearyl Stearate

210. Cetyl Babassuate

211. Cetyl Tallowate

212. C10‐40 Isoalkyl Acid Octyldodecanol Esters

213. C4‐5 Isoalkyl Cocoate

214. C32‐36 Isoalkyl Stearate

215. Coco‐Caprylate

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216. Coco‐Caprylate/Caprate

217. Coco‐Rapeseedate

218. Decyl Castorate

219. Decyl Cocoate

220. Decyl Jojobate

221. Decyl Olivate

222. Decyltetradecyl Cetearate

223. Ethylhexyl Adipate/Palmitate/Stearate

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224. Ethylhexyl C10‐40 Isoalkyl Acidate

225. Ethylhexyl Cocoate

226. Ethylhexyl Olivate

227. Hexyldodecyl/Octyldecyl Hydroxystearate

228. Hydrogenated Castor Oil Behenyl Esters

229. Hydrogenated Castor Oil Cetyl Esters

230. Hydrogenated Castor Oil Stearyl Esters

231. Hydrogenated Ethylhexyl Olivate

232. Hydrogenated Ethylhexyl Sesamate

233. Hydrogenated Isocetyl Olivate (one example of an “iso”)

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234. Hydrogenated Isopropyl Jojobate

235. Isobutyl Tallowate

236. Isodecyl Cocoate (one example of an “iso”)

237. Isooctyl Caprylate/Caprate (one example of an “iso”)

238. Isooctyl Tallate (one example of an “iso”)

239. Isopropyl Avocadate (one example of an “iso”)

240. Isopropyl Babassuate (one example of an “iso”)

241. Isopropyl Jojobate

242. Isopropyl Tallowate

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243. Isostearyl Avocadate (one example of an “iso”)

244. Lauryl Cocoate

245. Octyldodecyl Avocadoate

246. Octyldodecyl Beeswax

247. Octyldodecyl Cocoate

248. Octyldodecyl Meadowfoamate

249. Octyldodecyl Olivate

250. Octyldodecyl Safflowerate

251. Stearyl Beeswax

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252. Stearyl Olivate

253. Tetradecylpropionates Chiefly:

Generally:

254. Tridecyl Cocoate

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TABLES Table 1. Alkyl Esters Group (presented alphabetically) Arachidyl Behenate Decyl Cocoate Isodecyl Stearate Arachidyl Erucate Decyl Isostearate Isohexyl Caprate Arachidyl Propionate Decyl Jojobate Isohexyl Laurate Batyl Isostearate Decyl Laurate Isohexyl Neopentanoate Batyl Stearate Decyl Myristate Isohexyl Palmitate Behenyl Beeswax Decyl Oleate Isolauryl Behenate Behenyl Behenate Decyl Olivate Isononyl Isononanoate Behenyl Erucate Decyl Palmitate Isooctyl Caprylate/Caprate Behenyl Isostearate Decyltetradecyl Cetearate Isooctyl Tallate Behenyl Olivate Decyltetradecyl Ethylhexanoate Isopropyl Isostearate Behenyl/Isostearyl Beeswax Erucyl Arachidate Isopropyl Arachidate Butyl Avocadate Erucyl Erucate Isopropyl Avocadate Butyl Babassuate Erucyl Oleate Isopropyl Babassuate Butyl Isostearate Ethylhexyl Adipate/Palmitate/Stearate Isopropyl Behenate Butyl Myristate Ethylhexyl C10-40 Isoalkyl Acidate Isopropyl Hydroxystearate Butyl Oleate Ethylhexyl Cocoate Isopropyl Jojobate Butyl Stearate Ethylhexyl Ethylhexanoate Isopropyl Laurate Butyloctyl Beeswax Ethylhexyl Hydroxystearate Isopropyl Linoleate Butyloctyl Behenate Ethylhexyl Isononanoate Isopropyl Myristate Butyloctyl Candelillate Ethylhexyl Isopalmitate Isopropyl Oleate Butyloctyl Cetearate Ethylhexyl Isostearate Isopropyl Palmitate Butyloctyl Oleate Ethylhexyl Laurate Isopropyl Ricinoleate Butyloctyl Palmitate Ethylhexyl Myristate Isopropyl Sorbate C10-40 Isoalkyl Acid Octyldodecanol Esters Ethylhexyl Neopentanoate Isopropyl Stearate C12-13 Alkyl Ethylhexanoate Ethylhexyl Oleate Isopropyl Tallowate C12-15 Alkyl Ethylhexanoate Ethylhexyl Olivate Isostearyl Avocadate C14-18 Alkyl Ethylhexanoate Ethylhexyl Palmitate Isostearyl Behenate C14-30 Alkyl Beeswax Ethylhexyl Pelargonate Isostearyl Erucate C16-36 Alkyl Stearate Ethylhexyl Stearate Isostearyl Ethylhexanoate C18-38 Alkyl Beeswax Heptyl Undecylenate Isostearyl Hydroxystearate C18-38 Alkyl C24-54 Acid Ester Heptylundecyl Hydroxystearate Isostearyl Isononanoate C20-40 Alkyl Behenate Hexyl Isostearate Isostearyl Isostearate C20-40 Alkyl Stearate Hexyl Laurate Isostearyl Laurate C30-50 Alkyl Beeswax Hexyldecyl Ethylhexanoate Isostearyl Linoleate C30-50 Alkyl Stearate Hexyldecyl Hexyldecanoate Isostearyl Myristate C32-36 Isoalkyl Stearate Hexyldecyl Isostearate Isostearyl Neopentanoate C40-60 Alkyl Stearate Hexyldecyl Laurate Isostearyl Palmitate C4-5 Isoalkyl Cocoate Hexyldecyl Oleate Isotridecyl Isononanoate Caprylyl Butyrate Hexyldecyl Palmitate Isotridecyl Laurate Caprylyl Caprylate Hexyldecyl Stearate Isotridecyl Myristate Caprylyl Eicosenoate Hexyldodecyl/Octyldecyl Hydroxystearate Isotridecyl Stearate Cetearyl Behenate Hydrogenated Castor Oil Behenyl Esters Lauryl Behenate Cetearyl Candelillate Hydrogenated Castor Oil Cetyl Esters Lauryl Cocoate Cetearyl Ethylhexanoate Hydrogenated Castor Oil Stearyl Esters Lauryl Ethylhexanoate Cetearyl Isononanoate Hydrogenated Ethylhexyl Olivate Lauryl Isostearate Cetearyl Nonanoate Hydrogenated Ethylhexyl Sesamate Lauryl Laurate Cetearyl Olivate Hydrogenated Isocetyl Olivate Lauryl Myristate Cetearyl Palmate Hydrogenated Isopropyl Jojobate Lauryl Oleate Cetearyl Palmitate Hydroxycetyl Isostearate Lauryl Palmitate Cetearyl Rice Branate Hydroxyoctacosanyl Hydroxystearate Lauryl Stearate Cetearyl Stearate Isoamyl Laurate Lignoceryl Erucate Cetyl Babassuate Isobutyl Myristate Myristyl Ethylhexanoate Cetyl Behenate Isobutyl Palmitate Myristyl Isostearate Cetyl Caprate Isobutyl Perlargonate Myristyl Laurate Cetyl Caprylate Isobutyl Stearate Myristyl Myristate Cetyl Dimethyloctanoate Isobutyl Tallowate Myristyl Neopentanoate Cetyl Esters Isocetyl Behenate Myristyl Stearate Cetyl Ethylhexanoate Isocetyl Ethylhexanoate Octyldecyl Oleate Cetyl Isononanoate Isocetyl Isodecanoate Octyldodecyl Avocadoate Cetyl Laurate Isocetyl Isostearate Octyldodecyl Beeswax Cetyl Myristate Isocetyl Laurate Octyldodecyl Behenate Cetyl Myristoleate Isocetyl Myristate Octyldodecyl Cocoate Cetyl Oleate Isocetyl Palmitate Octyldodecyl Erucate Cetyl Palmitate Isocetyl Stearate Octyldodecyl Ethylhexanoate Cetyl Ricinoleate Isodecyl Cocoate Octyldodecyl Hydroxystearate Cetyl Stearate Isodecyl Ethylhexanoate Octyldodecyl Isostearate Cetyl Tallowate Isodecyl Hydroxystearate Octyldodecyl Meadowfoamate Chimyl Isostearate Isodecyl Isononanoate Octyldodecyl Myristate Chimyl Stearate Isodecyl Laurate Octyldodecyl Neodecanoate Coco-Caprylate Isodecyl Myristate Octyldodecyl Neopentanoate Coco-Caprylate/Caprate Isodecyl Neopentanoate Octyldodecyl Octyldodecanoate Coco-Rapeseedate Isodecyl Oleate Octyldodecyl Oleate Decyl Castorate Isodecyl Palmitate Octyldodecyl Olivate

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Table 1. Alkyl Esters Group (presented alphabetically) Octyldodecyl Ricinoleate Stearyl Caprylate Tetradecyloctadecyl Stearate Octyldodecyl Safflowerate Stearyl Erucate Tetradecylpropionates Octyldodecyl Stearate Stearyl Ethylhexanoate Tridecyl Behenate Oleyl Arachidate Stearyl Heptanoate Tridecyl Cocoate Oleyl Erucate Stearyl Linoleate Tridecyl Erucate Oleyl Linoleate Stearyl Olivate Tridecyl Ethylhexanoate Oleyl Myristate Stearyl Palmitate Tridecyl Isononanoate Oleyl Oleate Stearyl Stearate Tridecyl Laurate Oleyl Stearate Tetradecyleicosyl Stearate Tridecyl Myristate Propylheptyl Caprylate Tetradecyloctadecyl Behenate Tridecyl Neopentanoate Stearyl Beeswax Tetradecyloctadecyl Hexyldecanoate Tridecyl Stearate Stearyl Behenate Tetradecyloctadecyl Myristate

Table 2. Conclusions (year issued) and data summaries of previously reviewed alkyl esters Alkyl Ester Conclusion (Year) Summary data Reference Arachidyl Propionate safe as used (1990; - maximum reported use concentration was up to 10% in lipstick formulations 32,33 reaffirmed 2008) - the acute oral LD50 in rats was >20 g/kg; up to 2500 mg/kg at concentrations of 25% in corn oil was not toxic in a 90-day oral study - the acute dermal LD50 in rabbits was > 2 g/kg - not a primary irritant to rabbit skin when tested undiluted, a formulation containing 7% was not irritating in a 24 h SIOPT, and a 10% solution was non-irritating and undiluted test article was slightly irritating in a cumulative irritation test; not a sensitizer when injected undiluted test material, and was not comedogenic when tested undiluted - undiluted test material and a formulation containing 7% were not irritating to rabbit eyes Butyl Myristate safe as used (1990; - reported to be used in the VCRP, but no concentration of use data were reported (2010 report) 34,35 2010) - was observed to enhance dermal penetration of some chemicals - the oral LD50 in rats was >8 g/kg - a single application of 2 g/kg was non-toxic and non-irritating in rabbits - a 24 h occlusive application of undiluted test material produced moderate irritation (PII = 2.88) in rabbits; a moderate irritant but not a sensitizer in guinea pigs when injected intradermally - non-irritating to rabbit eyes - Discussion item: data on myristic acid myristyl and isopropyl myristate were extrapolated and also used in the determination of safety (1990 report) Butyl Stearate safe as used (1985, - maximum reported use concentration was up to 25% in leave-on formulations (primarily in lip- 36,37 reaffirmed 2005) sticks) and rinse-off formulations - the acute oral LD50 in rats was >32 g/kg; in a 2 yr feeding study in rats with up to 6000 mg/kg/day, no test article-related toxicity was observed - dietary administration of 6.25% for to male and female rats for 10 wks prior to mating did not affect fertility, litter size, or neonate survival, but growth was decrease pre- and post-weaning - undiluted test material was at most moderately irritating (in one study) to rabbit skin (PIIs ranged from 0-2.75); 0.1% in physiological saline was not a sensitizer in 2 guinea pigs when tested using intracutaneous injections; 50% in mineral oil weakly comedogenic in rabbits in a 2 wk study - in human testing, 24 and 48 h occlusive patch testing with 2% in formulation resulted in PIIs of 0.03 and 0.11, respectively (number of subjects not specified); 50% in mineral oil was at most a mild irritant and was not a sensitizer in an RIPT (111 subjects); 10% in formulation was not an irritant, sensitizer, (54 subjects) or photosensitizer (10 subjects) - undiluted test material was not irritating to rabbit eyes Cetearyl Ethylhexanoate safe as used (1982, - maximum reported use concentration was up to 25% in leave-on and rinse-off formulations 38,39 (originally, Cetearyl reaffirmed 2006) - acute oral LD50 was >8.0 ml/kg in rats; formulations containing 2.5% produced no acute oral toxicity Octanoate) - the acute dermal LD50 was >9.4 ml/kg in rabbits (only 2 rabbits in each group); formulations containing 25-30% produced no acute dermal toxicity; not toxic in rabbits when applied undiluted dermal for up to 90 days but mild irritation was reported - no inhalation toxicity in rats exposed for 1 h to a formulation containing 1.9-2.2% - was not a dermal irritant in rabbits when tested undiluted and in formulation (2.5%); not at sensitizer in guinea pigs as a 0.1% solution or in a formulation containing 3.2%; a formulation containing 2.5% was not phototoxic in guinea pigs - in human testing, 4/100 patients had a slight to moderate reaction tin a provocative SIOPT test with undiluted test article; a formulation containing 0.40% was essentially non-irritating in a 21-day cumulative irritation study in 13 subjects; formulations containing 0.2-30% were not sensitizers in RIPTs with 644 subjects and a formulation containing 0.40% was not a sensitizer in a maximization study in 25 subjects; although some reactions were observed, a formulation containing 2.5% was not considered a photoallergen in a study in 27 subjects; a formulation containing 2.5% was not phototoxic in 10 subjects - was not an ocular irritant in rabbits when tested undiluted and in formulation (2.5-30%) - a formulation containing 25-30% did not produce irritation in mucous membranes - Discussion item: 2-ethylhecanoic acid, a possible metabolite, was shown to be a liver and developmental toxicant in animal studies at high dose levels, and it was postulated that the maternal liver toxicity began a cascade of effects that included metallothionein (MT) induction, zinc accumulation in the liver due to MT binding, and a resulting zinc deficiency in the developing embryo; the Panel found that results of testing with di-2ethylhexyl terephthalate (a 2-ethylhexanoic acid precursor used as a

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Table 2. Conclusions (year issued) and data summaries of previously reviewed alkyl esters Alkyl Ester Conclusion (Year) Summary data Reference model for exposure without liver toxicity, etc,) and the fact that cetearyl ethylhexanoate would have to pass through the stratum corneum before entering the blood stream precluded the risk of developmental toxicity Cetearyl Isononanoate safe as used (2010) - maximum reported use concentration was 50% in leave-on formulations 40 - the oral LD50 in mice was >5 g/kg; in an oral study in which rats were dosed with 100, 300, or 1000 mg/kg, reversible fatty alterations were induced in the liver of female mid dose and male and female high dose animals and the NOAEL was 100 mg/kg/day - not a reproductive toxicant in a study in which 100-1000 mg/kg was administered orally to gravid rats on days 6-15 of gestation, and the NOAEL for maternal and embryo-/fetotoxicity was 100 mg/kg - not mutagenic in an Ames test at doses up to 5000 µg/plate with or without metabolic activation - slightly irritating to the skin of hairless mice and not irritating to rabbit skin; no a sensitizer in guinea pigs (25% injected intracutaneously at induction and challenge); 10-100% was not comedogenic in rabbit ears - in human testing, 20% active and undiluted test material had very good skin compatibility in a 24-h SIOPT (21 subjects); a formulation containing 1.5% was not a contact allergen in a maximization test (25 subjects) and undiluted test material was not an irritant or sensitizer in a provocative RIPT (20 eczema patients) - 10% active was not irritating to rabbit eyes Discussion items: because of the skin penetration enhancement property of pelargonic acid in the presence of p-aminobenzoic acid, care should be taken in formulating products containing this ingredient in combination with any ingredients whose safety was based on lack of dermal absorption or when dermal absorption was a concern; because animal sources have been reported, this ingredient must be free of detectable pathogenic viruses or infectious agents Cetearyl Nonanoate safe as used (2010) - maximum reported use concentration was 3% in leave-on formulations 40 - the oral LD50 in rats was 2 g/kg - the acute dermal LD50 in rats was >2 g/kg and there was no dermal irritation observed - undiluted test material (97% pure) was non-irritating to rabbit skin; not a sensitizer in a GPMT (10% for intracutaneous induction, 50% for topical induction, 10% at challenge, sesame oil was the vehicle) - not mutagenic in an Ames test at doses up to 5000 µg/plate with or without metabolic activation - in human testing, undiluted test material (97% pure) was not an irritant in a 48-h SIOPT (52 subjects); undiluted test material was not an irritant or a sensitizer in a RIPT (106 subjects) - undiluted test material was minimally irritating to rabbit eyes Discussion items: because of the skin penetration enhancement property of pelargonic acid in the presence of p-aminobenzoic acid, care should be taken in formulating products containing this ingredient in combination with any ingredients whose safety was based on lack of dermal absorption or when dermal absorption was a concern Cetyl Esters safe as used (1997) - concentration of use data were not reported 1 - (synonymous with synthetic spermaceti wax) a commercial cetyl esters preparation comprised of a mixture of one or more of the following esters: cetyl palmitate, myristyl myristate, cetyl stearate, myristyl stearate, cetyl myristate, and stearyl stearate - the oral LD50 in mice of a formulation containing 60-65% >20 g/kg - a formulation containing 60-65% was not irritating to rabbit skin in a 24 h SIOPT - a formulation containing 60-65% was not an irritant to rabbit eyes Discussion item: data from the safety assessments on cetyl palmitate, myristyl myristate, cetyl stearate, and myristyl stearate were extrapolated to determine safety Cetyl Isononanoate safe as used (2010) - maximum reported use concentration was 5% in leave-on formulations 40 - no data were available Discussion items: because of the skin penetration enhancement property of pelargonic acid in the presence of p-aminobenzoic acid, care should be taken in formulating products containing this ingredient in combination with any ingredients whose safety was based on lack of dermal absorption or when dermal absorption was a concern; because animal sources have been reported, this ingredient must be free of detectable pathogenic viruses or infectious agents Cetyl Myristate safe as used (2010) - maximum reported use concentration was 6% in leave-on formulations 34 - no data were available - Discussion item: data on myristic acid and some of its salts and esters were appropriate for extrapolation to determine safety Cetyl Palmitate safe as used (1982; -maximum reported concentration of use was up to 10% in a lipstick (1 formulation); primarily used at 36,41 reaffirmed in 2005) up to 5% in leave-on formulations - was quantitatively excreted in the feces when fed at 20%in the diet - acute oral LD50 was > 14.4 g/kg in rats; not toxic in a 9-day dietary study in rats - no mortality was observed when a 50% slurry was applied to rabbit skin under an occlusive patch - was at most mildly irritating in rabbits when applied undiluted or in formulation (2.5-2.7%) under occlusion; a 1% suspension produced minimal irritation and was not sensitizing in the Landsteiner and Jacobs test in guinea pigs - in humans, a formulation containing 2.7% was not a primary irritant (10 subjects); in maximization studies, a formulation containing 2.5% was classified as a weak potential sensitizer that was unlikely to present a risk of contact sensitization under conditions of normal use (50 subjects) and one containing 2.7% was classified as a weak potential sensitizer of the lowest grade (25 subjects); a formulation containing 2.7% was not phototoxic (10 subjects) or photoallergenic (25 subjects); low irritation potential was observed in in-use studies (28-56 days;30-100 subjects per study) - minimally irritating to rabbit eyes; OIIs ranged from 0.3 – 6.7 for undiluted test material and 0.0 for a 5% (w/w) dispersion 38

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Table 2. Conclusions (year issued) and data summaries of previously reviewed alkyl esters Alkyl Ester Conclusion (Year) Summary data Reference Cetyl Ricinoleate safe as used (2007) - maximum reported use concentration was up to 10% in leave-on formulations (reported for lipsticks) 42 - the acute oral LD50 in mice was >2 g/kg - not irritating to rabbit skin (test concentration not stated) - Discussion item: safety test data on Ricinus Communis (Castor) Seed Oil, which contains ricinoleic acid (and for which data were included), was considered applicable for extrapolation to determine safety; retrospective study reports of sensitization reactions to ricinoleic acid in patients with eczematous cheilitis was determined to be expected in that patient group but not the general population, and based on the Panel’s expertise and experience, the incidence of positive reactions to ricinoleic acid were very low Cetyl Stearate safe as used (1985, - maximum reported use concentration was up to 10% in leave-on formulations 36,37 reaffirmed 2005) - 50% in mineral oil was at most a mild irritant and was not a sensitizer in an RIPT (111 subjects), although sensitization was reported in 1 subject Decyl Cocoate safe as used (2011) - was not reported to be used 43 - no data were available Discussion items: because there is no reason to expect the toxicity to differ from that of coconut oil, coconut acid, hydrogenated coconut oil, and hydrogenated coconut acid and therefore the data available on these ingredients are supportive of safety; necessary procedures should be continued by the cosmetics industry to limit pesticide residues and heavy metals Decyl Myristate safe as used (2010) - was not reported to be used 34 - no data were available - Discussion item: data on myristic acid and some of its salts and esters were appropriate for extrapolation to determine safety Decyl Oleate safe as used (1982; - maximum reported concentration of use was >50% in leave-on formulations 3,44 reaffirmed in 2003) - the acute oral LD50 was > 40 ml/kg and >5 g/kg in rats - in a primary dermal irritation study using rabbits, the PIIs for a 10% solution in corn oil, and 20% solution in mineral oil, and undiluted test material were 0.08, 0.05, and 0.28, respectively, and in a modified Draize test, a 15% solution in polyoxyethylene sorbitan stearate (3%), preservative (2%), and water and undiluted test material were non-irritating; in an 8-wk study in rabbits, daily application of the 15% solution produced some papulae or vesicles but was generally well tolerated and the undiluted material resulted in skin thickening in 3 rabbits (total tested not stated) and vesicles in 1 rabbit and was poorly tolerated; a 15% solution in corn oil was not a sensitizer in the Landsteiner and Jacobs test in guinea pigs - in human testing, not sensitization was reported in a RIPT in 103-subject with a formulation containing 1-5% or in 402 subjects with 4 formulations containing 5.5% - at most, a very slight irritant to rabbit eyes when tested undiluted Ethylhexyl Cocoate safe as used (2011) - maximum reported use concentration was 41% in leave-on formulations- no data were available 43 Discussion items: because there is no reason to expect the toxicity to differ from that of coconut oil, coconut acid, hydrogenated coconut oil, and hydrogenated coconut acid and therefore the data available on these ingredients are supportive of safety; necessary procedures should be continued by the cosmetics industry to limit pesticide residues and heavy metals Ethylhexyl Isononanoate safe as used (2010) - maximum reported use concentration was 74% in leave-on formulations 40 - not mutagenic in an Ames test at doses up to 5000 µg/plate with or without metabolic activation - in human testing, undiluted test material did not indicate potential for allergic contact sensitization in an RIPT (10 subjects) Discussion items: because of the skin penetration enhancement property of pelargonic acid in the presence of p-aminobenzoic acid, care should be taken in formulating products containing this ingredient in combination with any ingredients whose safety was based on lack of dermal absorption or when dermal absorption was a concern Ethylhexyl Myristate safe as used (2010) - was not reported to be used 34 - no data were available - Discussion item: data on myristic acid and some of its salts and esters were appropriate for extrapolation to determine safety Ethylhexyl Palmitate safe as used (1982; - maximum reported use concentration was up to 50% in leave-on and rinse-off formulations 36,41 (originally, Octyl Palmitate) reaffirmed in 2005) - the acute oral LD50 was >64 ml/kg in rats - the acute dermal LD50 was >9.4 ml/kg in rabbits (only 2 rabbits in each group); dermal toxicity was not observed in a 6 wk dermal study with undiluted material; undiluted test material was “poorly tolerated” in a 60-day study with “congestive dermatitis” in 2/3 rabbits - was a mild irritant tested undiluted in an SIOPT in rabbits; 0.1% suspensions were not sensitizers in the Landsteiner and Jacobs test in guinea pigs - in human studies, 3 formulations containing 1-5% and one containing 40-50% tested in 48-h occlusive tests with 100 subjects and 3 formulations containing 45.72-46.52% tested in an 18 day occlusive RIPT with 20 subjects were not irritants, and in a 21-day occlusive RIPT a formulations containing 42.25% resulted in signs of irritation in 7/24 subjects and the avg. cumulative irritation score was 2.58/84 - OIIs for undiluted test material ranged from 0.33 – 4.17 in 3 Draize studies, indicating that it did not cause significant injury to rabbit eyes Ethylhexyl Pelargonate safe as used (2010) - maximum reported use concentration was 25% in leave-on formulations 40 - the acute oral LD50 in rats was >5 g/kg - undiluted test material was not irritating to rabbit skin (PII = 0.40) - undiluted test material was not irritating to rabbit eyes Discussion items: because of the skin penetration enhancement property of pelargonic acid in the 39

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Table 2. Conclusions (year issued) and data summaries of previously reviewed alkyl esters Alkyl Ester Conclusion (Year) Summary data Reference presence of p-aminobenzoic acid, care should be taken in formulating products containing this ingredient in combination with any ingredients whose safety was based on lack of dermal absorption or when dermal absorption was a concern Ethylhexyl Stearate safe as used (1985, - maximum reported use concentration was up to 5% in formulations diluted for use 36,37 (originally Octyl Stearate) reaffirmed 2005) - the acute oral LD50 in rats was >8 ml/kg - undiluted test material was at most mildly irritating to rabbit skin (PIIs 0.0 and 1.42); in a 6-day cumulative skin irritation study, undiluted test material had a MMII of 0.67 and was poorly tolerated and a 10% aq. solution had a MMII of 0.33 was relatively well tolerated - in human testing, a formulation containing 7.6% was not an irritant or sensitizer (56 subjects), not phototoxic (10 subjects), and not a photosensitizer (27 subjects), although some slight reactions were reported in the photosensitization study - undiluted test material did not provoke any significant injury in rabbit eyes (max PII 4.67/100 at 1 h) Discussion item: the Panel noted that the reproductive toxicity of 2-ethyl-1-hexanol was addressed in a fetotoxicity study (performed on diethylhexyl adipate); it was suggested that the fetotoxicity reported for mice in that study was actually due to a zinc deficiency and that given the extent of 2-ethyl-1- hexanol absorption and the load that would be expected to enter the hepatic circulation, the potential for 2-ethyl-1-hexanol-induced reproductive toxicity was not thought to be an issue Isobutyl Myristate safe as used (2010) - maximum reported use concentration was 30% in leave-on formulations 34 - no data were available - data on myristic acid and some of its salts and esters were appropriate for extrapolation to determine safety Isobutyl Pelargonate safe as used (2010) - was not reported to be used 40 - no data were available Discussion items: because of the skin penetration enhancement property of pelargonic acid in the presence of p-aminobenzoic acid, care should be taken in formulating products containing this ingredient in combination with any ingredients whose safety was based on lack of dermal absorption or when dermal absorption was a concern Isobutyl Stearate safe as used (1985, - undiluted test material was mildly irritating to rabbit skin (PIIs =0.62) in a 24 h occlusive study 36,37 reaffirmed 2005) - in human testing, a mild irritant and not a sensitizer when tested undiluted in an RIPT (149 subjects); 50% in mineral oil was not phototoxic or a photosensitizer (23 subjects) Isocetyl Myristate safe as used (2010) - reported to be used in the VCRP, but no concentration of use data were reported 34 - no data were available - Discussion item: data on myristic acid and some of its salts and esters were appropriate for extrapolation to determine safety Isocetyl Stearate safe as used (1985, - maximum reported use concentration was up to 25% in leave-on formulations and rinse-off 36,37 reaffirmed 2005) formulations - the acute oral LD50 in rats was >10 g/kg - undiluted test material was at most mildly irritating to rabbit skin (PIIs ranged from 0.0-1.0); 0.1% in physiological saline was not a sensitizer in 2 guinea pigs when tested using intracutaneous injections - in human testing, undiluted test material was minimally irritating in a SIOPT (40 subjects); undiluted (149 subjects) test material and 50% in mineral oil (111 subjects) were mild irritants and not sensitizers in RIPTs; 50% in mineral oil was not phototoxic or a photosensitizer (23 subjects) - undiluted test material was a slight irritant in rabbit eyes (max. PII 10.67/110 at 1 h) Isodecyl Cocoate safe as used (2011) - was not reported to be used- no data were available 43 Discussion items: because there is no reason to expect the toxicity to differ from that of coconut oil, coconut acid, hydrogenated coconut oil, and hydrogenated coconut acid and therefore the data available on these ingredients are supportive of safety; necessary procedures should be continued by the cosmetics industry to limit pesticide residues and heavy metals Isodecyl Isononanoate safe as used (2010) - maximum reported use concentration was 26% in leave-on formulations 40 - in human testing, a formulation containing 51.35% was not an irritant or sensitizer in a RIPT (101 subjects) and a formulation containing 2.6% was not a contact allergen in a maximization test (26 subjects) Discussion items: because of the skin penetration enhancement property of pelargonic acid in the presence of p-aminobenzoic acid, care should be taken in formulating products containing this ingredient in combination with any ingredients whose safety was based on lack of dermal absorption or when dermal absorption was a concern Isodecyl Myristate safe as used (2010) - reported to be used in the VCRP, but no concentration of use data were reported 34 - no data were available - Discussion item: data on myristic acid and some of its salts and esters were appropriate for extrapolation to determine safety Isodecyl Oleate safe as used (1982; - maximum reported concentration of use was up to 25% in leave-on and rinse-off formulations 3,44 reaffirmed in 2003) - the acute LD50 was > 40 ml/kg in rats - undiluted test material had a PII of 1.0 in 3 rabbits, but subsequent testing reported a PII of 0.28 and additional studies with undiluted the a 15% solution in polyoxyethylene sorbitan stearate (3%), preservative (2%), and water indicated reported the material was non-irritating (PII scores of 0.0 and 0.13 for the undiluted material and 0.0 for the 15% solution); in an 8-wk study in rabbits, daily application of the 15% solution produced episodical macules, papulae, and vesicles but was relatively well tolerated and the undiluted material was poorly tolerated with congestive dermis effects; a 15% solution in corn oil was not a sensitizer in the Landsteiner and Jacobs test in guinea pigs - in humans, undiluted test material was not an irritant in an SIOPT in 19 subjects and in a 21-day cumulative irritancy test in 9 subjects with undiluted material, the irritation score was 1.0/756 40

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Table 2. Conclusions (year issued) and data summaries of previously reviewed alkyl esters Alkyl Ester Conclusion (Year) Summary data Reference - at most, a very slight irritant to rabbit eyes when tested undiluted Isononyl Isononanoate safe as used (2010) - maximum reported use concentration was 64% in rinse-off and 57% in leave-on formulations 40 - the acute oral LD50 in rats was >5 g/kg; 300 and 1000 mg/kg/day induced mortality and all doses (100-1000mg/kg/day) induced liver and kidney toxicity in a 4-wk oral study in rats - 300 mg/kg/day (2 wks) and 860 mg/kg/day (8 days) induced liver and adrenal gland toxicity in a dermal study in rats - did not induce direct embryotoxicity or fetotoxicity in rats at doses up to 3000 mg/kg/day - not mutagenic in an Ames test at doses up to 5000 µg/plate with or without metabolic activation - slightly irritating to rabbit skin (study details not provided) - in human testing, lipstick formulations containing 3.552% (53 subjects) and 3.128% (97 subjects) were not irritants or sensitizers in RIPTs and a formulation containing 24.66% was not a contact allergen in a maximization test (26 subjects) - not irritating to rabbit eyes (concentration tested was not stated) Discussion items: because of the skin penetration enhancement property of pelargonic acid in the presence of p-aminobenzoic acid, care should be taken in formulating products containing this ingredient in combination with any ingredients whose safety was based on lack of dermal absorption or when dermal absorption was a concern; the sex- and species-specific hyaline droplet nephropathy was not considered relevant to man Isopropyl Isostearate safe as used (1992, - maximum reported use concentration was 50% in a leave-on formulation 45,46 reaffirmed in 2011) - undiluted test material was a non-irritant (PII = 0.42) in rabbit skin 24 and 72 h after application, and in an 8-wk study a 10% aq. solution was relatively well tolerated (IIMM = 2.00) but the undiluted material was poorly tolerated (IIMM = 3.34) and discontinued after 5 wks; undiluted test material induced severe comedones sin rabbit ears - 10% aq. and undiluted test material were slight ocular irritants in rabbit eyes Discussion item: because limited toxicological data (dermal irritation, ocular irritation, and comedogenicity data) were available, the Panel used data on similar isopropyl esters that had already been reviewed and found safe to determine safety Isopropyl Linoleate insufficient to - maximum reported use concentration was up to 10% in leave-on formulations 47 support safety - the oral LD50 in rats of 10% in corn oil was >64 cc/kg (1992) - 10% aq. and undiluted test material were classified as slightly irritant and non-irritant, respectively, in primary irritation studies in rabbits; both 10% aq. and undiluted test materials were slight irritants when he study was repeated with purer samples; in another primary skin irritation study, 10% in corn oil did not product any irritation reactions in albino rabbits - 10% aq. and undiluted test material were slight ocular irritants, while 10% in corn oil was not irritating to rabbit eyes Discussion item: human irritation and sensitization data and genotoxicity data were needed Isopropyl Myristate safe as used (1982; - maximum reported concentration of use was 82% in leave-on formulations (2010 report) 34,48 2010) - in a study in which monkeys were exposed for 5 sec to an aerosol antiperspirant containing test material, the distribution in the exhaled air and in several tissues indicated only 0.25% of the sprayed dose was absorbed and about 10% of this reached the lower respiratory tract - the acute oral LD50 was >16 ml/kg in rats and 49.7 ml/kg in mice - the acute dermal LD50 in rabbits was 5 g/kg; dermal application of 2 g/kg a formulation containing 16-20% in rabbits for 26 days (20 applications) did not produce signs of toxicity but did cause severe erythema and moderate edema and other dermal effects and microscopically marked to severe acan- thosis and hyperkeratosis and mixed inflammatory cell infiltration; application of 2 ml/kg of a formulation containing 43-47% in rabbits for 4 wks (21 applications) produced erythema, edema, drying, cracking, and fissuring, but microscopic effects were only seen at the application site - 1 h inhalation exposure to formulations containing 16-20% (33-41 mg/l) and 4.7% (9.7 mg/l) did not produce any deaths or evidence of systemic toxicity in rats; in 13-wk inhalation studies, a formulation containing 16-20% was not toxic to guinea pigs (daily mean concentration of 63.3-224 mg/m3 air for three 1-h exposures/day) but did produced coughing and wheezing in monkeys and macrophage accumulations within the alveolar and bronchiolar walls were seen in the lungs in direct proportion to the dosage of the aerosol (5.3-37.0 mg/m3 in air) - a 50% solution in isopropyl alcohol significantly accelerated the carcinogenic activity of 0.15% benzo[a]pyrene on the skin of mice; no tumors were produced in mice by application of a 1% solution for 18 wks; applications of 10-100% to the backs of Swiss mice 2x/wk did not result in test article- related carcinogenic lesions - in Draize tests, undiluted test material and 15-58% in formulations was at mostly minimally irritating in rabbits, however, application of undiluted test material for 3 days was moderately to severely irritating; produced comedogenic activity in rabbit ears - in human testing, undiluted test material was not irritating (15 subjects) and the highest PII with formulations containing 15-58% was 0.1 (9-50%) in primary irritation studies; in cumulative irritation studies, undiluted test material (25 subjects) and formulations containing 15-58% (9-13 subjects) were minimally irritating; no sensitization was seen in maximization studies (20% in pet. or -42.9% in formulation; 25 subjects) or RIPTs (15 and 52-58%; 99 and 320 subjects); a formulation containing 42.9% was not phototoxic (10 subjects) or a photoallergen (25 subjects0 - undiluted material was minimally irritating to rabbit eyes and formulations containing 15-58% were non- to mildly irritating - not genotoxic in the Salmonella/microsome test Isopropyl Palmitate safe as used (1982; - maximum reported concentration of use was up to 50% in leave-on, rinse-off, and diluted for use 36,41 reaffirmed in 2005) formulations - the acute oral LD50 was >64 ml/kg in rats

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Table 2. Conclusions (year issued) and data summaries of previously reviewed alkyl esters Alkyl Ester Conclusion (Year) Summary data Reference

- the dermal LD50 was >2.0 ml/kg in rabbits - no inhalation toxicity in rats exposed to 200mmg/l for 1 h - undiluted test material was non-irritating to slightly irritating to rabbit skin - in human testing, in 3 studies with 24-h occlusive patches with undiluted test material performed in a total of 160 subjects, all scores there were five irritation scores of 0.5/4, and the remained were 0/4 and in a 10-day primary irritation study, a formulation containing 45.6% was not irritating in 10 subjects; not a sensitizer when tested undiluted in an RIPT with 102 subjects or in formulation at 45.6% in a maximization test with 25 subjects; a formulation containing 45.6% was not phototoxic (10 subjects) or photoallergenic (25 subjects) - OIIs ranged from 0.0 – 6.5 in 5 Draize studies, indicating that it did not cause significant injury to rabbit eyes Isopropyl Ricinoleate safe as used (2007) - was not reported to be used 42 - no specific safety data were available - Discussion item: safety test data on Ricinus Communis (Castor) Seed Oil, which contains ricinoleic acid (and for which data were included), was considered applicable for extrapolation to determine safety; retrospective study reports of sensitization reactions to ricinoleic acid in patients with eczematous cheilitis was determined to be expected in that patient group but not the general population, and based on the Panel’s expertise and experience, the incidence of positive reactions to ricinoleic acid were very low Isopropyl Stearate safe as used (1985, - maximum reported use concentration was up to 25% in a leave-on formulation 36,37 reaffirmed 2005) - the acute oral LD50 in rats was >8 ml/kg - undiluted test material was moderately irritating to rabbit skin (PIIs 2.35 in two studies) - in human testing, 1.0% in formulation was non- (105 subjects) to slightly irritating (12 subjects) and produced no adverse reactions in a 4-wk use test (40 subjects) - undiluted test material was not irritating to rabbit eyes Isostearyl Isononanoate safe as used (2010) - was not reported to be used 40 -no data were available Discussion items: because of the skin penetration enhancement property of pelargonic acid in the presence of p-aminobenzoic acid, care should be taken in formulating products containing this ingredient in combination with any ingredients whose safety was based on lack of dermal absorption or when dermal absorption was a concern; because animal sources have been reported, this ingredient must be free of detectable pathogenic viruses or infectious agents Isostearyl Myristate safe as used (2010) - was not reported to be used 34 - mixed results were seen regarding dermal penetration enhancement - in a study in which monkeys were exposed for 5 sec to an aerosol antiperspirant containing test material, the distribution in the exhaled air and in several tissues indicated only 0.25% of the sprayed dose was absorbed and about 10% of this reached the lower respiratory tract - no other data were available - Discussion item: data on myristic acid and some of its salts and esters were appropriate for extrapolation to determine safety Isostearyl Neopentanoate safe as used (1985, - maximum reported use concentration was up to 50% in leave-on formulations 39,49 reaffirmed in 2006) - the acute oral LD50 was >40 ml/kg in rats; in a 93 day study, oral administration of undiluted test material in rats was safe in terms of cumulative systemic toxicity - undiluted test material applied under a 24 h patch was not irritating to rabbit skin and formulations containing 1.2 – 32% was a most mildly irritating in rabbits; not considered a sensitizer in a GPMT (observations were attributed to scratches) and not a sensitizer in the Landsteiner and Jacobs test in guinea pigs; a formulation containing 3% was a mild primary skin irritant but was not phototoxic; 50% in mineral oil was marginally comedogenic and undiluted was non-comedogenic in rabbit ears - in human testing, was non-irritating in a 48-h SIOPT when tested undiluted or in formulations containing 3-5% (10 or 100 subjects), 4% in formulation (20 subjects) was minimally irritating (PII = 0.08) and 1,2% in formulation was non-irritating (20 subjects) in a 24-h SIOPT, a formulation containing 3% was mildly irritating in a 21-day study (15 subjects); undiluted test material and formulations containing 5-32% were not sensitizers in RIPT studies (52-210 subjects per study), although some irritation was reported; a formulation containing 16.05% was not phototoxic or a photoallergen in 27 subjects - undiluted test material was minimally irritating in rabbit eyes and formulations containing 1.2 – 36% were at most minimally irritating Discussion items: because of the skin penetration enhancement property of pelargonic acid in the presence of p-aminobenzoic acid, care should be taken in formulating products containing this ingredient in combination with any ingredients whose safety was based on lack of dermal absorption or when dermal absorption was a concern Isotridecyl Isononanoate safe as used (2010) - maximum reported use concentration was 51% in leave-on formulations 40 - in human testing, a formulation containing 4.3% was not a contact allergen in a maximization test (28 subjects) Discussion items: because of the skin penetration enhancement property of pelargonic acid in the presence of p-aminobenzoic acid, care should be taken in formulating products containing this ingredient in combination with any ingredients whose safety was based on lack of dermal absorption or when dermal absorption was a concern Isotridecyl Myristate safe as used (2010) - was not reported to be used 34 - no data were available - Discussion item: data on myristic acid and some of its salts and esters were appropriate for

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Table 2. Conclusions (year issued) and data summaries of previously reviewed alkyl esters Alkyl Ester Conclusion (Year) Summary data Reference extrapolation to determine safety Lauryl Cocoate safe as used (2011) - was not reported to be used- no data were available 43 Discussion items: because there is no reason to expect the toxicity to differ from that of coconut oil, coconut acid, hydrogenated coconut oil, and hydrogenated coconut acid and therefore the data available on these ingredients are supportive of safety; necessary procedures should be continued by the cosmetics industry to limit pesticide residues and heavy metals Lauryl Myristate safe as used (2010) - reported to be used in the VCRP, but no concentration of use data were reported 34 - no data were available - Discussion item: data on myristic acid and some of its salts and esters were appropriate for extrapolation to determine safety Myristyl Myristate safe as used (1982; - maximum reported concentration of use was 17% in leave-on formulations (2010 report) 34,48 2010) - the acute oral LD50 in rats was>14.4 g/kg - the acute dermal LD50 in rabbits was >2 g/kg - undiluted test material was at most mildly irritating in rabbits; produced comedogenic activity in rabbit ears - in human studies, 8% in formulation was not an irritant (20 subjects) or sensitizer (196 subjects) - undiluted material, 15-50% in corn oil, and formulations containing 15-58% were non- to minimally irritating in rabbit eyes - Discussion item: data on myristic acid and some of its salts and esters were appropriate for extrapolation to determine safety Myristyl Stearate safe as used (1985, - maximum reported use concentration was up to 5% in a leave-on formulation 36,37 reaffirmed 2005) - the acute oral LD50 in mice was >10 g/kg with corn oil and >1 g/kg neat - undiluted test material was not irritating to rabbit skin (PII = 0.0) - in human testing, formulations containing 2.35 – 9.8% produced no skin reactions in open and closed patch tests 22-100 subjects/test) - undiluted test material produced slight vessel injection involving only the conjunctivae at 24 h and no irritation was observed on days 2-7 Octyldodecyl Cocoate safe as used (2011) - was not reported to be used- no data were available 43 Discussion items: because there is no reason to expect the toxicity to differ from that of coconut oil, coconut acid, hydrogenated coconut oil, and hydrogenated coconut acid and therefore the data available on these ingredients are supportive of safety; necessary procedures should be continued by the cosmetics industry to limit pesticide residues and heavy metals Octyldodecyl Myristate safe as used (2010) - maximum reported use concentration was 21% in leave-on formulations (reported for lipsticks) 34 - no data were available Discussion item: data on myristic acid and some of its salts and esters were appropriate for extrapolation to determine safety Octyldodecyl Ricinoleate safe as used (2007) - maximum reported use concentration was 5% in leave-on formulations (lipsticks) 42 - no specific safety data were available - Discussion item: safety test data on Ricinus Communis (Castor) Seed Oil, which contains ricinoleic acid (and for which data were included), was considered applicable for extrapolation to determine safety; retrospective study reports of sensitization reactions to ricinoleic acid in patients with eczematous cheilitis was determined to be expected in that patient group but not the general population, and based on the Panel’s expertise and experience, the incidence of positive reactions to ricinoleic acid were very low Oleyl Myristate safe as used (2010) - was not reported to be used 34 - no data were available Discussion item: data on myristic acid and some of its salts and esters were appropriate for extrapolation to determine safety Stearyl Behenate safe as used (2010) - maximum reported use concentration was 0.02% in leave-on formulations 50 - no data were available Discussion items: data from the original review on stearyl heptanoate were applicable to determine safety, including extrapolated data on stearyl alcohol and heptanoic acid Stearyl Caprylate safe as used (2010) - maximum reported use concentration was 1% in leave-on formulations 50 - no data were available Discussion items: data from the original review on stearyl heptanoate were applicable to determine safety, including extrapolated data on stearyl alcohol and heptanoic acid Stearyl Heptanoate safe as used (1995, - maximum reported use concentration was 8% in leave-on formulations (2010) 50,51 reaffirmed 2010) - the oral LD50 in rats was >16 ml/kg - a mixture that also contained stearyl caprylate was not mutagenic in an Ames test with or without metabolic activation and had no clastogenic effect in an in vivo micronucleus test in which mice were given a single oral dose of 500-1500 mg/kg in corn oil - undiluted test material was mildly irritating to rabbit skin (PII = 1.21/8); a formulation containing 1.5% was not a sensitizer in guinea pigs; a formulation containing 1.5% produced slight to moderate comedogenicity in rabbit ears - in human testing, cosmetic formulations containing 0.7% (198 subjects) and 1.5% (156, 194, and 202 subjects) were not sensitizers in RIPTs - undiluted test material was a Category 3 ocular irritant in rabbit eyes and a formulation containing 1.5% was not a primary ocular irritant Discussion items: although irritation testing was performed at 100%, sensitization testing was only performed with a maximum concentration of 1.5%; however, there was no indication that this

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Table 2. Conclusions (year issued) and data summaries of previously reviewed alkyl esters Alkyl Ester Conclusion (Year) Summary data Reference ingredient would be a sensitizer; mild reactions were observed in ocular irritation studies with undiluted material and no irritation with a formulation containing 1.5%, therefore the Panel was of the opinion that in formulation, this ingredient would not produce significant ocular irritation; because there was limited information available, data on stearyl alcohol and heptanoic acid were extrapolated to determine safety Stearyl Olivate safe as used (2010) - reported to be used in the VCRP, but no concentration of use data were reported 50 - no data were available Discussion items: data from the original review on stearyl heptanoate were applicable to determine safety, including extrapolated data on stearyl alcohol and heptanoic acid Stearyl Palmitate safe as used (2010) - maximum reported use concentration was 3% in leave-on formulations 50 - no data were available Discussion items: data from the original review on stearyl heptanoate were applicable to determine safety, including extrapolated data on stearyl alcohol and heptanoic acid; data from the CIR safety assessment on palmitic acid were also extrapolated Stearyl Stearate safe as used (2010) - maximum reported use concentration was 4% in leave-on formulations 50 - no data were available Discussion items: data from the original review on stearyl heptanoate were applicable to determine safety, including extrapolated data on stearyl alcohol and heptanoic acid; data from the CIR safety assessment on stearic acid were also extrapolated Tetradecyloctadecyl safe as used (2010) - was not reported to be used 34 Myristate - no data were available Discussion item: data on myristic acid and some of its salts and esters were appropriate for extrapolation to determine safety Tridecyl Cocoate safe as used (2011) - was not reported to be used- no data were available 43 Discussion items: because there is no reason to expect the toxicity to differ from that of coconut oil, coconut acid, hydrogenated coconut oil, and hydrogenated coconut acid and therefore the data available on these ingredients are supportive of safety; necessary procedures should be continued by the cosmetics industry to limit pesticide residues and heavy metals Tridecyl Isononanoate safe as used (2010) - maximum reported use concentration was 9% in a leave-on formulation 40 - no data were available Discussion items: because of the skin penetration enhancement property of pelargonic acid in the presence of p-aminobenzoic acid, care should be taken in formulating products containing this ingredient in combination with any ingredients whose safety was based on lack of dermal absorption or when dermal absorption was a concern Tridecyl Myristate safe as used (2010) - was not reported to be used 34 - no data were available Discussion item: data on myristic acid and some of its salts and esters were appropriate for extrapolation to determine safety

Abbreviations: GPMT = guinea pig maximization test; IIMM = maximum irritation index; OII =ocular irritation index; PII = primary irritation index; RIPT = repeated insult patch test; SIOPT = single insult occlusive patch test

Table 3. Alkyl Esters Group (grouped by whether individual constituents have been reviewed) INGREDIENTS HAVE BEEN REVIEWED BY THE CIR AND FOUND SAFE* Arachidyl Propionate Ethylhexyl Stearate Isotridecyl Myristate Butyl Myristate Isobutyl Myristate Lauryl Cocoate Butyl Stearate Isobutyl Perlargonate Lauryl Myristate Cetearyl Ethylhexanoate Isobutyl Stearate Myristyl Myristate Cetearyl Isononanoate Isocetyl Myristate Myristyl Stearate Cetearyl Nonanoate Isocetyl Stearate Octyldodecyl Cocoate Cetyl Esters Isodecyl Cocoate Octyldodecyl Myristate Cetyl Isononanoate Isodecyl Isononanoate Octyldodecyl Ricinoleate Cetyl Myristate Isodecyl Myristate Oleyl Myristate Cetyl Palmitate Isodecyl Oleate Stearyl Behenate Cetyl Ricinoleate Isononyl Isononanoate Stearyl Caprylate Cetyl Stearate Isopropyl Isostearate Stearyl Heptanoate Decyl Cocoate Isopropyl Myristate Stearyl Olivate Decyl Myristate Isopropyl Palmitate Stearyl Palmitate Decyl Oleate Isopropyl Ricinoleate Stearyl Stearate Ethylhexyl Cocoate Isopropyl Stearate Tetradecyloctadecyl Myristate Ethylhexyl Isononanoate Isostearyl Isononanoate Tridecyl Cocoate Ethylhexyl Myristate Isostearyl Myristate Tridecyl Isononanoate Ethylhexyl Palmitate Isostearyl Neopentanoate Tridecyl Myristate Ethylhexyl Pelargonate Isotridecyl Isononanoate

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Table 3. Alkyl Esters Group (grouped by whether individual constituents have been reviewed) BOTH THE ACID AND THE ALCOHOL HAVE BEEN FOUND SAFE BY THE CIR Batyl Isostearate Cetyl Oleate Isostearyl Isostearate Batyl Stearate Chimyl Isostearate Isostearyl Laurate Behenyl Isostearate Chimyl Stearate Isostearyl Palmitate Behenyl Olivate Hydrogenated Castor Oil Behenyl Esters Myristyl Isostearate Butyl Isostearate Hydrogenated Castor Oil Cetyl Esters Myristyl Laurate Butyl Oleate Hydrogenated Castor Oil Stearyl Esters Octyldodecyl Hydroxystearate Cetearyl Olivate Isopropyl Hydroxystearate Octyldodecyl Isostearate Cetearyl Palmate Isopropyl Laurate Octyldodecyl Oleate Cetearyl Palmitate Isopropyl Oleate Octyldodecyl Olivate Cetearyl Rice Branate Isopropyl Sorbate Octyldodecyl Stearate Cetearyl Stearate Isostearyl Hydroxystearate Oleyl Oleate Cetyl Laurate Oleyl Stearate THE ACID OR THE ALCOHOL HAS BEEN FOUND SAFE BY THE CIR Behenyl Beeswax Ethylhexyl Oleate Isostearyl Behenate Behenyl Behenate Erucyl Oleate Isostearyl Erucate Behenyl Erucate Heptylundecyl Hydroxystearate Isostearyl Ethylhexanoate Behenyl/Isostearyl Beeswax Hexyldecyl Isostearate Isostearyl Linoleate Butyl Avocadate Hexyldecyl Laurate Isotridecyl Laurate Butyl Babassuate Hexyldecyl Oleate Isotridecyl Stearate Butyloctyl Cetearate** Hexyldecyl Palmitate Lauryl Isostearate Butyloctyl Oleate Hexyldecyl Stearate Lauryl Laurate Butyloctyl Palmitate Hexyldodecyl/Octyldecyl Hydroxystearate Lauryl Oleate C16-36 Alkyl Stearate Hexyl Isostearate Lauryl Palmitate C20-40 Alkyl Stearate Hexyl Laurate Lauryl Stearate C30-50 Alkyl Stearate Hydrogenated Ethylhexyl Olivate Myristyl Ethylhexanoate C40-60 Alkyl Stearate Hydrogenated Ethylhexyl Sesamate Myristyl Neopentanoate Cetearyl Behenate Hydrogenated Isocetyl Olivate Octyldecyl Oleate Cetearyl Candelillate Hydrogenated Isopropyl Jojobate Octyldodecyl Avocadoate Cetyl Babassuate Hydroxycetyl Isostearate Octyldodecyl Beeswax Cetyl Behenate Hydroxyoctacosanyl Hydroxystearate Octyldodecyl Behenate Cetyl Caprate Isoamyl Laurate Octyldodecyl Erucate Cetyl Caprylate Isobutyl Palmitate Octyldodecyl Ethylhexanoate Cetyl Dimethyloctanoate Isocetyl Isostearate Octyldodecyl Meadowfoamate Cetyl Ethylhexanoate Isocetyl Laurate Octyldodecyl Neodecanoate Cetyl Tallowate Isocetyl Palmitate Octyldodecyl Neopentanoate C10-40 Isoalkyl Acid Octyldodecanol Esters Isodecyl Hydroxystearate Octyldodecyl Octyldodecanoate C4-5 Isoalkyl Cocoate Isodecyl Laurate Octyldodecyl Safflowerate C32-36 Isoalkyl Stearate Isodecyl Palmitate Oleyl Arachidate Coco-Caprylate Isodecyl Stearate Oleyl Erucate Coco-Caprylate/Caprate Isohexyl Laurate Oleyl Linoleate Coco-Rapeseedate Isohexyl Palmitate Stearyl Beeswax Decyl Isostearate Isooctyl Tallate Stearyl Erucate Decyl Laurate Isopropyl Arachidate Stearyl Ethylhexanoate Decyl Palmitate Isopropyl Avocadate Stearyl Linoleate Decyltetradecyl Cetearate Isopropyl Babassuate Tetradecyleicosyl Stearate Ethylhexyl Adipate/Palmitate/Stearate Isopropyl Behenate Tetradecyloctadecyl Stearate Ethylhexyl Hydroxystearate Isopropyl Jojobate Tridecyl Laurate Ethylhexyl Isostearate Isopropyl Tallowate Tridecyl Stearate Ethylhexyl Laurate Isostearyl Avocadate CIR HAS NOT CONCLUDED ON THE SAFETY OF THE ACID OR THE ALCOHOL Arachidyl Behenate Decyl Jojobate Isodecyl Neopentanoate Arachidyl Erucate Decyltetradecyl Ethylhexanoate Isohexyl Caprylate Butyloctyl Beeswax Ethylhexyl C10-40 Isoalkyl Acidate Isohexyl Neopentanoate Butyloctyl Behenate Ethylhexyl Ethylhexanoate Isolauryl Behenate Butyloctyl Candelillate Ethylhexyl Isopalmitate Isooctyl Caprylate/Caprate C14-30 Alkyl Beeswax Ethylhexyl Neopentanoate Lauryl Behenate C18-38 Alkyl Beeswax Ethylhexyl Olivate Lauryl Ethylhexanoate C30-50 Alkyl Beeswax Erucyl Arachidate Lignoceryl Erucate C20-40 Alkyl Behenate Erucyl Erucate Propylheptyl Caprylate C18-38 Alkyl C24-54 Acid Ester Heptyldecyl Undecylenate Tetradecyloctadecyl Behenate C12-13 Alkyl Ethylhexanoate Hexyldecyl Ethylhexanoate Tetradecyloctadecyl Hexyldecanoate C12-15 Alkyl Ethylhexanoate Hexyldecyl Hexyldecanoate Tetradecylpropionates C14-18 Alkyl Ethylhexanoate Isobutyl Tallowate Tridecyl Behenate Caprylyl Butyrate Isocetyl Behenate Tridecyl Erucate Caprylyl Caprylate Isocetyl Ethylhexanoate Tridecyl Ethylhexanoate Caprylyl Eicosenoate Isocetyl Isodecanoate Tridecyl Neopentanoate Decyl Castorate Isodecyl Ethylhexanoate *Isopropyl Linoleate was reviewed previously by the CIR, with a conclusion of insufficient data to support safety **the acid component is a mixture of fatty acids, containing predominantly palmitic and stearic acids, both of which have been reviewed

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Table 4. Constituent alcohols and acids with CIR conclusions Constituent Conclusion (year issued) Reference ALCOHOLS Batyl Alcohol safe as used (2011) 52 Behenyl Alcohol safe as used (1988; reaffirmed 2008) 33,53 Butyl Alcohol safe as used (2008) 54 Cetearyl Alcohol safe as used (1988; reaffirmed 2008) 33,53 Cetyl Alcohol safe as used (1988; reaffirmed 2008) 33,53 Cetyl Glycol (Hydroxycetyl Alcohol) safe as used (2011) 55 Chimyl Alcohol safe as used (2011) 52 Coconut Alcohol safe as used (2011) 43 Isopropyl Alcohol safe as used (2010) 56 Isostearyl Alcohol safe as used (1988; reaffirmed 2008) 33,53 Jojoba Alcohol safe as used (2008) 57 Myristyl Alcohol safe as used (1988; reaffirmed 2008) 33,53 Octyldodecanol safe as used (1985, reaffirmed 2006) 39,58 Oleyl Alcohol safe as used (1985; reaffirmed 2006) 39,58 Stearyl Alcohol safe as used (1985; reaffirmed 2006) 39,58 ACIDS Adipic Acid safe as used (2010) 59 Babassu Acid safe as used (2011) 60 Coconut Acid safe as used (2011) 43,60 Hydroxystearic Acid safe as used (1998) 61 Isostearic Acid safe as used (1983; reaffirmed in 2005) 36,62 Lauric Acid safe as used (1987; reaffirmed in 2006) 39,63 Myristic Acid safe as used (2010) 34 Oleic Acid safe as used (1987; reaffirmed in 2006) 39,63 Olive Acid safe as used (2011) 60 Palm Acid safe as used (2011) 60 Palmitic Acid safe as used (1987; reaffirmed in 2006) 39,63 Pelargonic Acid safe as used (2011) 40 Rice Bran Acid safe as used (2011) 60 Ricinoleic Acid safe as sued (2007) 42 Safflower Acid safe as used (2011) 60 Sorbic Acid safe as used (1988; reaffirmed in 2008) 33,64 Stearic Acid safe as used (1987; reaffirmed in 2006) 39,63 Tall Oil Acid safe as used (1989; reaffirmed in 2009) 65,66

Table 5. Definitions and functions Ingredient/CAS No. Definition4 (italicized text generated by CIR) Function4 Arachidyl Behenate the ester of arachidyl alcohol and behenic acid. The ester obtained from the reaction skin cond. agent – oc.; visc. incr. 42233-14-7 of arachidyl alcohol with behenic acid. agent – nonaq. Arachidyl Erucate the ester of arachidyl alcohol and erucic acid. The ester obtained from the reaction of skin cond. agent – emol. 86601-86-7 arachidyl alcohol with erucic acid. Arachidyl Propionate the ester of arachidyl alcohol and n-propionic acid. The ester obtained from the skin cond. agent – emol. 65591-14-2 reaction of arachidyl alcohol and n-propionic acid. Batyl Isostearate an ester of Batyl Alcohol and Isostearic Acid. The mixture of esters obtained from skin cond. agent – oc. 170754-20-8 the reaction of batyl alcohol with branched-chain stearic acids. Batyl Stearate an ester of Batyl Alcohol and stearic acid. The ester obtained from the reaction of skin cond. agent – oc. 13232-26-3 batyl alcohol with stearic acid. Behenyl Beeswax the ester of Behenyl Alcohol and Beeswax Acid. The mixture of esters obtained skin cond. agent – oc. from the reaction of behenyl alcohol with a mixture of straight-chain fatty acids, containing 24 to 36 carbons in alkyl chain length (beeswax acid). Behenyl Behenate the ester of Behenic Acid and Behenyl Alcohol. The ester obtained from the reaction skin cond. agent – oc. 17671-27-1 of behenic acid with behenyl alcohol. Behenyl Erucate the ester of Behenyl Alcohol and erucic acid. The ester obtained from the reaction of skin cond. agent – oc. 18312-32-8 behenyl alcohol with erucic acid. Behenyl Isostearate the ester of Behenyl Alcohol and isostearic acid that conforms to the formula. The skin cond. agent – oc. 181496-25-3 mixture of esters obtained from the reaction of behenyl alcohol with branched-chain stearic acids. Behenyl/Isostearyl Beeswax the ester of a mixture of Behenyl Alcohol and Isostearyl Alcohol with Beeswax Acid. skin cond. agent – oc. The mixture of esters obtained from the reaction of behenyl alcohol and branched- chain stearyl alcohols with a mixture of straight-chain fatty acids, containing 24 to 36 carbons in alkyl chain length (beeswax acid).

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Table 5. Definitions and functions Ingredient/CAS No. Definition4 (italicized text generated by CIR) Function4 Behenyl Olivate the ester of behenyl alcohol and Olive Acid that conforms generally to the formula. skin cond. agent – misc.; emul. The mixture of esters obtained from the reaction of behenyl alcohol with the fatty stabilizer; film former; slip modi- acids derived from olive acid. fier; visc, incr. agent – nonaq. Butyl Avocadate the ester of butyl alcohol and the fatty acids derived from Persea Grattisima skin cond. agent – misc. (Avocado) Oil. The mixture of esters obtained from the reaction of butyl alcohol with the fatty acids derived from Persea Grattisima (Avocado) Oil. Butyl Babassuate the ester of butyl alcohol and the fatty acids derived from babassu oil. The mixture disp. agent-nonsurf.; emul. stab.; of esters obtained from the reaction of butyl alcohol with the fatty acids derived from skin cond, agent -emol; surf.- babassu oil. solub. agent Butyl Isostearate the ester of butyl alcohol and isostearic acid that conforms to the formula. The skin cond, agent -emol mixture of esters obtained from the reaction of butyl alcohol with branched-chain stearic acids. Butyl Myristate the ester of butyl alcohol and myristic acid. The ester obtained from the reaction of skin cond, agent -emol 110-36-1 butyl alcohol with myristic acid. Butyl Oleate the ester of butyl alcohol and oleic acid. The ester obtained from the reaction of skin cond, agent –emol.; fragrance 142-77-8 butyl alcohol with oleic acid. ingr. Butyl Stearate the ester of butyl alcohol and stearic acid. The ester obtained from the reaction of skin cond, agent –emol.; fragrance 123-95-5 butyl alcohol and stearic acid. ingr. Butyloctyl Beeswax the ester of Butyloctanol and Beeswax Acid. The mixture of esters obtained from the skin cond. agent – oc. 151661-98-2 reaction of 2-butyloctanol with a mixture of straight-chain fatty acids, containing 24 to 36 carbons in alkyl chain length (beeswax acid). Butyloctyl Behenate the organic compound that conforms to the formula. The ester obtained from the skin cond. agent – emol. reaction of 2-butyloctanol with behenic acid. Butyloctyl Candelillate the ester of 2-butyloctanol and the acids derived from Euphorbia Cerifera skin cond. agent – oc. 226994-03-2 (Candelilla) Wax. The mixture of esters obtained from the reaction of 2-butyloctanol with the fatty acids derived from Euphorbia Cerifera (Candelilla) Wax. Butyloctyl Cetearate the ester of Butyloctanol and a blend of fatty acids containing predominantly palmitic skin cond. agent – emol. 101227-08-1 and stearic acid. The mixture of esters obtained from the reaction of 2-butyloctanol with a mixture of fatty acids containing predominately palmitic acid and stearic acid. Butyloctyl Oleate the ester of butyloctanol and oleic acid. The ester obtained from the reaction of skin cond. agent – oc. 2-butyloctanol with oleic acid. Butyloctyl Palmitate the ester of Butyloctanol and Palmitic Acid. The ester obtained from the reaction of skin cond. agent – emol. 2-butyloctanol with palmitic acid. C14-30 Alkyl Beeswax the ester of a mixture of fatty alcohols containing 14 to 30 carbons in the alkyl chain skin cond. agent – oc. 209225-40-1 with Beeswax Acid. The mixture of esters obtained from the reaction of a mixture of fatty alcohols, containing 14 to 30 carbons in the alkyl chain, with a mixture of straight-chain fatty acids, containing 24 to 36 carbons in alkyl chain (beeswax acid). C18-38 Alkyl Beeswax the ester of a mixture of fatty alcohols containing 18 to 38 carbon atoms in the alkyl skin cond. agent – oc. 223706-17-0 chain and Beeswax Acid. The mixture of esters obtained from the reaction of a mixture of fatty alcohols, containing 18 to 38 carbons in the alkyl chain, with a mixture of straight-chain fatty acids, containing 24 to 36 carbons in alkyl chain (beeswax acid). C30-50 Alkyl Beeswax the ester of C30-50 Alcohols and Beeswax Acid. The mixture of esters obtained skin cond. agent – oc. 223707-19-5 from the reaction of a mixture of fatty alcohols, containing 30 to 50 carbons in the alkyl chain, with a mixture of straight-chain fatty acids, containing 24 to 36 carbons in alkyl chain (beeswax acid). C20-40 Alkyl Behenate the ester of C20-40 Alcohols and behenic acid. The mixture of esters obtained from skin cond. agent – oc. the reaction of a mixture of fatty alcohols, containing 20 to 40 carbons in the alkyl chain, with behenic acid. C18-38 Alkyl C24-54 Acid Ester the ester of a mixture of fatty alcohols containing 18 to 38 carbon atoms and a visc. incr. agent – nonaq. mixture of fatty acids containing 24 to 54 carbon atoms. The mixture of esters obtained from the reaction of a mixture of fatty alcohols, containing 30 to 50 carbons in the alkyl chain, with a mixture of straight-chain fatty acids, containing 24 to 54 carbons in alkyl chain. C12-13 Alkyl Ethylhexanoate the ester of C12-13 Alcohols and 2-ethylhexanoic acid. The mixture of esters skin cond. agent – emol. 90411-66-8 obtained from the reaction of a mixture of fatty alcohols, containing 12 to 13 carbons in the alkyl chain, with 2-ethylhexanoic acid. C12-15 Alkyl Ethylhexanoate the ester of 2-ethylhexanoic acid and C12-15 Alcohols. The mixture of esters skin cond. agent – emol. 90411-66-8 obtained from the reaction of a mixture of fatty alcohols, containing 12 to 15 carbons in the alkyl chain, with 2-ethylhexanoic acid. C14-18 Alkyl Ethylhexanoate the ester of C14-18 alcohols and 2-ethylhexanoic acid. The mixture of esters skin cond. agent – emol. obtained from the reaction of a mixture of fatty alcohols, containing 14 to 18 carbons in the alkyl chain, with 2-ethylhexanoic acid. C16-36 Alkyl Stearate the ester of C16-36 alcohols and Stearic Acid. The mixture of esters obtained from skin cond. agent – oc. the reaction of a mixture of fatty alcohols, containing 16 to 36 carbons in the alkyl chain, with stearic acid. C20-40 Alkyl Stearate the ester of C20-40 Alcohols and stearic acid. The mixture of esters obtained from skin cond. agent – oc.; visc. incr. the reaction of a mixture of fatty alcohols, containing 20 to 40 carbons in the alkyl agent-aq. chain, with stearic acid. C30-50 Alkyl Stearate the ester of C30-50 Alcohols and Stearic Acid. The mixture of esters obtained from skin cond. agent – oc. the reaction of a mixture of fatty alcohols, containing 30 to 50 carbons in the alkyl chain, with stearic acid.

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Table 5. Definitions and functions Ingredient/CAS No. Definition4 (italicized text generated by CIR) Function4 C40-60 Alkyl Stearate the ester of C40-60 Alcohols and Stearic Acid. The mixture of esters obtained from skin cond. agent – oc. the reaction of a mixture of fatty alcohols, containing 40 to 60 carbons in the alkyl chain, with stearic acid. Caprylyl Butyrate the ester of n-octanol with butyric acid that conforms to the formula. The ester skin cond. agent – misc.; fragrance 110-39-4 obtained from the reaction of n-octanol with butyric acid. ingredient Caprylyl Caprylate the organic compound that conforms to the formula. The ester obtained from the skin cond. agent – emol. 2306-88-9 reaction of n-octanol with n-octanoic acid. Caprylyl Eicosenoate the organic compound that conforms to the formula. The ester obtained from the skin cond. agent – misc. reaction of n-octanol with 11-eicosenoic acid. Cetearyl Behenate the ester of Cetearyl Alcohol and Behenic Acid. The mixture of esters obtained from skin cond. agent – oc. the reaction of a mixture of fatty alcohols, containing 16 to 18 carbons in the alkyl chain, with behenic acid. Cetearyl Candelillate the ester of Cetearyl Alcohol and the fatty acids derived from Euphorbia Cerifera skin cond. agent – oc. (Candelilla) Wax. The mixture of esters obtained from the reaction of a mixture of fatty alcohols, containing 16 to 18 carbons in the alkyl chain, with the fatty acids derived from Euphorbia Cerifera (Candelilla) Wax. Cetearyl Ethylhexanoate the ester of cetearyl alcohol and 2-ethylhexanoic acid. The mixture of esters obtained skin cond. agent-emol.; hair cond. from the reaction of a mixture of fatty alcohols, containing 16 to 18 carbons in the agent alkyl chain, with 2-ethylhexanoic acid. Cetearyl Isononanoate the ester of cetearyl alcohol and a branched chain nonanoic acid. The mixture of skin cond. agent-emol.; hair cond. esters obtained from the reaction of a mixture of fatty alcohols, containing 16 to 18 agent carbons in the alkyl chain, with branched chain nonanoic acid. Cetearyl Nonanoate the organic compound that conforms to the formula. The mixture of esters obtained skin cond. agent-emol. 878027-13-5 from the reaction of a mixture of fatty alcohols, containing 16 to 18 carbons in the alkyl chain, with nonanoic acid. Cetearyl Olivate the ester of Cetearyl Alcohol and the fatty acids derived from olive oil. The mixture hair cond. agent of esters obtained from the reaction of a mixture of fatty alcohols, containing 16 - 18 carbons in the alkyl chain, with the fatty acids derived from olive oil. Cetearyl Palmate the ester of Cetearyl Alcohol and Palm Acid. The mixture of esters obtained from skin cond. agent – emol.; emul. the reaction of a mixture of fatty alcohols, containing 16 to 18 carbons in the alkyl stab. chain, with the fatty acids derived from palm acid. Cetearyl Palmitate the ester of Cetearyl Alcohol and palmitic acid. The mixture of esters obtained from skin cond. agent-emol.; hair cond. 85341-79-3 the reaction of a mixture of fatty alcohols, containing 16 to 18 carbons in the alkyl agent chain, with palmitic acid. Cetearyl Rice Branate the ester of Cetearyl Alcohol and Rice Bran Acid. The mixture of esters obtained skin cond. agent – misc. from the reaction of a mixture of fatty alcohols, containing 16 to 18 carbons in the alkyl chain, with the fatty acids derived from rice bran acid. Cetearyl Stearate the ester of Cetearyl Alcohol and stearic acid. The mixture of esters obtained from skin cond. agent – oc. 93820-97-4 the reaction of a mixture of fatty alcohols, containing 16 to 18 carbons in the alkyl chain, with stearic acid. Cetyl Babassuate the ester of cetyl alcohol and the fatty acids derived from Orbignya Oleifera skin cond. agent – emol.; visc. 613236-40-1 (Babassu) Oil. The mixture of esters obtained from the reaction of cetyl alcohol with incr. agent-aq. the fatty acids derived from Orbignya Oleifera (Babassu) Oil. Cetyl Behenate the ester of that conforms to the formula. The ester obtained from the reaction of skin cond. agent – oc. 42233-11-4 cetyl alcohol with behenic acid. Cetyl Caprate the ester of cetyl alcohol and capric acid. The ester obtained from the reaction of skin cond. agent – emol. cetyl alcohol with capric acid. Cetyl Caprylate the ester of cetyl alcohol and caprylic acid. The ester obtained from the reaction of skin cond. agent – emol. 29710-31-4 cetyl alcohol with caprylic acid. Cetyl Dimethyloctanoate the ester of cetyl alcohol and dimethyloctanoic acid. The ester obtained from the skin cond. agent – emol. reaction of cetyl alcohol with dimethyloctanoic acid. Cetyl Esters a synthetic wax intended to be indistinguishable from natural spermaceti wax with skin cond. agent– emol. regard to composition and properties. It consists of a mixture of esters of 14 to 18 carbon fatty acids and alcohols. The mixture of esters obtained from the reaction of a mixture of fatty alcohols, containing 14 to 18 carbons in the alkyl chain, with a mixture of straight-chain fatty acids, containing 14 to 18 carbons in the alkyl chain. Cetyl Ethylhexanoate the ester of cetyl alcohol and 2-ethylhexanoic acid. The ester obtained from the skin cond. agent – emol. 59130-69-7 reaction of cetyl alcohol with 2-ethylhexanoic acid. Cetyl Isononanoate the ester of cetyl alcohol with a branched chain nonanoic acid. The mixture of esters skin cond. agent – emol. 84878-33-1 obtained from the reaction of cetyl alcohol with branched-chain nonanoic acids. Cetyl Laurate the ester of cetyl alcohol and lauric acid that conforms to the formula. The ester skin cond. agent – emol. 20834-06-4 obtained from the reaction of cetyl alcohol with lauric acid. Cetyl Myristate the ester of cetyl alcohol and myristic acid. The ester obtained from the reaction of skin cond. agent – oc. 2599-01-1 cetyl alcohol and myristic acid. Cetyl Myristoleate the ester of Cetyl Alcohol and myristoleic acid that conforms to the formula. The skin cond. agent – misc. ester obtained from the reaction of cetyl alcohol and myristoleic acid. Cetyl Oleate the ester of cetyl alcohol and oleic acid. The ester obtained from the reaction of cetyl skin cond. agent – emol. 22393-86-8 alcohol with oleic acid. Cetyl Palmitate the ester of cetyl alcohol and palmitic acid. The ester obtained from the reaction of skin cond, agent –oc.; fragrance 540-10-3 cetyl alcohol with palmitic acid. ingr. Cetyl Ricinoleate the ester of cetyl alcohol and ricinoleic acid. The ester obtained from the reaction of skin cond. agent – oc. 10401-55-5 cetyl alcohol with ricinoleic acid.

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Table 5. Definitions and functions Ingredient/CAS No. Definition4 (italicized text generated by CIR) Function4 Cetyl Stearate the ester of cetyl alcohol and stearic acid. The ester obtained from the reaction of skin cond. agent – oc. 1190-63-2 cetyl alcohol with stearic acid. Cetyl Tallowate the ester of Cetyl Alcohol and Tallow Acid. The mixture of esters obtained from the skin cond. agent – misc. reaction of cetyl alcohol with the fatty acids derived from tallow acid. Chimyl Isostearate the ester of Chimyl Alcohol and isostearic acid. The mixture of esters obtained from skin cond. agent – emol. the reaction of cetyl glyceryl ether with branched-chain stearic acids. Chimyl Stearate the ester of Chimyl Alcohol and stearic acid. The ester obtained from the reaction of skin cond. agent – emol. 131932-18-8 cetyl glyceryl ether with stearic acid. C10-40 Isoalkyl Acid a mixture of esters of Octyldodecanol with branched-chain alkyl acids containing 10 skin cond. agent – misc.; visc. Octyldodecanol Esters to 40 carbons. The mixture of esters obtained from the reaction of 2-octyldodecanol incr. agent-nonaq. with branched-chain fatty acids, containing 10 to 40 carbons in the alkyl chain. C4-5 Isoalkyl Cocoate the ester of a branched, saturated fatty alcohol containing 4 to 5 carbons, with skin cond. agent – emol. Coconut Acid. The mixture of esters obtained from the reaction of branched-chain alcohols, containing 4 to 5 carbons, with the fatty acids derived from coconut acid. C32-36 Isoalkyl Stearate the ester of a branched, saturated fatty alcohol containing 32 to 36 carbons, with skin cond. agent – emol. 68201-22-9 stearic acid. The mixture of esters obtained from the reaction of branched-chain alcohols, containing 32 to 36 carbons, with stearic acid. Coco-Caprylate the organic compound that conforms to the formula. The mixture of esters obtained skin cond. agent – emol. from the reaction of the fatty alcohols derived from coconut alcohol with caprylic acid. Coco-Caprylate/Caprate a mixture of esters of Coconut Alcohol with Caprylic Acid and Capric Acid. The skin cond. agent – emol. mixture of esters obtained from the reaction of the fatty alcohols derived from coconut alcohol with a mixture of caprylic acid and capric acid. Coco-Rapeseedate the ester of Coconut Alcohol and the fatty acids derived from Brassica Campestris skin cond. agent – emol. (Rapeseed) Oil. The mixture of esters obtained from the reaction of the fatty alcohols derived from coconut alcohol with the fatty acids derived from Brassica Campestris (Rapeseed) Oil. Decyl Castorate the ester of Decyl Alcohol and the fatty acids derived from Ricinus Communis skin cond. agent – emol.; emul. (Castor) Oil. The mixture of esters obtained from the reaction of decyl alcohol with stab. the fatty acids derived from Ricinus Communis (Castor) Oil. Decyl Cocoate the ester of Decyl Alcohol and the fatty acids derived from Cocos Nucifera skin cond. agent – oc. (Coconut) Oil. The mixture of esters obtained from the reaction of decyl alcohol with the fatty acids derived from Cocos Nucifera (Coconut) Oil. Decyl Isostearate the ester of decyl alcohol and isostearic acid. The mixture of esters obtained from the skin cond. agent – emol. 84605-08-3 reaction of decyl alcohol with branched-chain stearic acids. Decyl Jojobate the ester of decyl alcohol and the fatty acids derived from Simmondsia Chinensis skin cond. agent – emol. (Jojoba) Oil. The mixture of esters obtained from the reaction of decyl alcohol with the fatty acids derived from Simmondsia Chinensis (Jojoba) Oil. Decyl Laurate the organic compound that conforms to the formula. The ester obtained from the skin cond. agent – emol. 36528-28-6 reaction of decyl alcohol with lauric acid. Decyl Myristate the ester of decyl alcohol and myristic acid that conforms to the formula. The ester skin cond. agent – oc. 41927-71-3 obtained from the reaction of decyl alcohol with myristic acid. Decyl Oleate the ester of decyl alcohol and oleic acid. The ester obtained from the reaction of skin cond. agent – emol. 3687-46-5 decyl alcohol with oleic acid. Decyl Olivate the ester of Decyl Alcohol and the fatty acids derived from Olea Europea (Olive) Oil. skin cond. agent – oc. The mixture of esters obtained from the reaction of decyl alcohol with the fatty acids derived from Olea Europea (Olive) Oil. Decyl Palmitate the ester of decyl alcohol and palmitic acid that conforms to the formula. The ester skin cond. agent – emol. 42232-27-9 obtained from the reaction of decyl alcohol with palmitic acid. Decyltetradecyl Cetearate the ester of Decyltetradecanol and a blend of fatty acids containing predominantly skin cond. agent – emol. 97404-34-7 palmitic and stearic acid. The mixture of esters obtained from the reaction of 2-decyltetradecanol with a mixture of fatty acids, containing predominantly palmitic acid and stearic acid. Decyltetradecyl Ethylhexanoate the organic compound that conforms to the formula. The ester obtained from the skin cond. agent – emol. reaction of 2-decyltetradecanol with 2-ethylhexanoic acid. Ethylhexyl Adipate/Palmitate/ a mixture of esters formed by the reaction of 2-ethylhexyl alcohol with adipic, skin cond. agent-emol. Stearate palmitic, and stearic acids. Ethylhexyl C10-40 Isoalkyl the ester of C10-40 Isoalkyl Acid and 2-ethylhexyl alcohol. The mixture of esters skin cond. agent-misc.; visc. incr. Acidate obtained from the reaction of 2-ethylhexyl alcohol with branched-chain acids, agent-nonaq. containing 10 to 40 carbons in the alkyl chain. Ethylhexyl Cocoate the ester of 2-ethylhexanol and Coconut Acid that conforms to the formula. The skin cond. agent-emol. 91052-62-9;92044-87-6 mixture of esters obtained from the reaction of 2-ethylhexyl alcohol with the fatty acids derived from coconut acid. Ethylhexyl Ethylhexanoate the ester of 2-ethylhexanol and 2-ethylhexanoic acid that conforms to the formula. skin cond. agent-emol.; fragrance 7425-14-1 The ester obtained from the reaction of 2-ethylhexanol with 2-ethylhexanoic acid. ingr. Ethylhexyl Hydroxystearate the ester of 2-ethylhexyl alcohol and 12-hydroxystearic acid. The ester obtained skin cond. agent-emol. 29383-26-4; 29710-25-6 from the reaction of 2-ethylhexyl alcohol with 12-hydroxystearic acid. Ethylhexyl Isononanoate the ester of 2-ethylhexyl alcohol and a branched chain nonanoic acid. The mixture of skin cond. agent-emol. 70969-70-9; 71566-49-9 esters obtained from the reaction of 2-ethylhexyl alcohol with branched-chain nonanoic acids. Ethylhexyl Isopalmitate the ester of 2-ethylhexanol and a branched chain 16 carbon aliphatic acid. The skin cond. agent-emol. 93843-32-4 mixture of esters obtained from the reaction of 2-ethylhexanol with branched-chain palmitic acids. 49

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Table 5. Definitions and functions Ingredient/CAS No. Definition4 (italicized text generated by CIR) Function4 Ethylhexyl Isostearate the ester of 2-ethylhexyl alcohol and isostearic acid. The mixture of esters obtained skin cond. agent-emol. 81897-25-8; 85186-76-1 from the reaction of 2-ethylhexyl alcohol with branched-chain stearic acids. Ethylhexyl Laurate the ester of 2-ethylhexyl alcohol and lauric acid. The ester obtained from the skin cond. agent-emol. 20292-08-4 reaction of 2-ethylhexyl alcohol with lauric acid. Ethylhexyl Myristate the ester of 2-ethylhexyl alcohol and myristic acid. The ester obtained from the skin cond. agent-emol. 29806-75-5 reaction of 2-ethylhexyl alcohol with myristic acid. Ethylhexyl Neopentanoate ester of 2-ethylhexanol and neopentanoic acid. The ester obtained from the reaction skin cond. agent-emol. of 2-ethylhexanol with neopentanoic acid. Ethylhexyl Oleate the ester of oleic acid and 2-ethyl hexyl alcohol. The ester obtained from the reaction skin cond. agent-emol. 26399-02-0 of 2-ethylhexyl alcohol with oleic acid. Ethylhexyl Olivate the ester of ethylhexyl alcohol and the fatty acids derived from Olea Europaea skin cond. agent-oc. (Olive) Oil. The mixture of esters obtained from the reaction of 2-ethylhexyl alcohol with the fatty acids derived from Olea Europaea (Olive) Oil. Ethylhexyl Palmitate the ester of 2-ethylhexyl alcohol and palmitic acid. The ester obtained from the skin cond. agent-emol.; fragrance 29806-73-3 reaction of 2-ethylhexyl alcohol with palmitic acid. ingr. Ethylhexyl Pelargonate the ester of 2-ethylhexyl alcohol and Pelargonic Acid. The ester obtained from the skin cond. agent-emol. 59587-44-9 reaction of 2-ethylhexyl alcohol with pelargonic acid. Ethylhexyl Stearate the ester of 2-ethylhexyl alcohol and stearic acid. The ester obtained from the skin cond. agent-emol. 22047-49-0 reaction of 2-ethylhexyl alcohol with stearic acid. Erucyl Arachidate the ester of erucyl alcohol and Arachidic Acid. The ester obtained from the reaction skin cond. agent-misc. of erucyl alcohol with arachidic acid. Erucyl Erucate the ester of erucyl alcohol and erucic acid. The ester obtained from the reaction of skin cond. agent-misc. 27640-89-7; 84605-12-9 erucyl alcohol with erucic acid. Erucyl Oleate the ester of erucyl alcohol and oleic acid that conforms to the formula. The ester skin cond. agent-misc. 85617-81-8 obtained from the reaction of erucyl alcohol with oleic acid. Heptyl Undecylenate the organic compound that conforms to the formula. The ester obtained from the skin cond. agent-emol. 68141-27-5 reaction of heptyl alcohol with 10-undecenoic acid. Heptylundecyl Hydroxystearate the organic compound that conforms to the formula. The ester obtained from the skin cond. agent-emol. 74659-69-1 reaction of 2-heptylundecyl alcohol with 12-hydroxystearate. Hexyldecyl Ethylhexanoate the ester of hexyldecanol and 2-ethylhexanoic acid. The ester obtained from the skin cond. agent-emol.; skin cond. reaction of 2-hexyldecanol with 2-ethylhexanoic acid. agent-oc. Hexyldecyl Hexyldecanoate the ester that conforms to the formula. The ester obtained from the reaction of skin cond. agent-emol. 2-hexyldecanol with 2-hexyldecanoic acid. Hexyldecyl Isostearate the ester of hexyldecyl alcohol and isostearic acid. The mixture of esters obtained skin cond. agent-oc. 69247-84-3 from the reaction of 2-hexyldecyl alcohol with branched-chain stearic acids. Hexyldecyl Laurate the ester of hexyldecanol and lauric acid. The ester obtained from the reaction of skin cond. agent-emol.; skin cond. 34362-27-1; 227450-65-9 2-hexyldecanol with lauric acid. agent-oc. Hexyldecyl Oleate the ester of Hexyldecanol and oleic acid. The ester obtained from the reaction of skin cond. agent-oc. 94278-07-6 2-hexyldecanol with oleic acid. Hexyldecyl Palmitate the ester of Hexyldecanol and palmitic acid that conforms to the formula. The ester skin cond. agent-oc. 69275-02-1 obtained from the reaction of 2-hexyldecanol with palmitic acid. Hexyldecyl Stearate the ester of Stearic Acid and Hexyldecanol. The ester obtained from the reaction of skin cond. agent-emol.; skin cond. 17618-45-0 2-hexyldecanol with stearic acid. agent-oc. Hexyldodecyl/Octyldecyl the product formed by the reaction of Hexyldodecanol and Octyldecanol with skin cond. agent-emol. Hydroxystearate Hydroxystearic Acid. The mixture of esters obtained from the reaction of a mixture of 2-hexyldodecanol and 2-octyldecanol with 12-hydroxystearic acid. Hexyl Isostearate the ester of hexyl alcohol and isostearic acid that conforms to the formula. The skin cond. agent-emol. 94247-25-3 mixture of esters obtained from the reaction of hexyl alcohol with branched-chain stearic acids. Hexyl Laurate the ester of hexyl alcohol and lauric acid. The ester obtained from the reaction of skin cond. agent-emol. 34316-64-8 hexyl alcohol with lauric acid. Hydrogenated Castor Oil Behenyl the hydrogenation product of the esters formed by the reaction of castor oil and hair cond. agent; binder; emul. Esters behenyl alcohol. The hydrogenation product of the mixture of esters obtained from stab. the reaction of behenyl alcohol with castor oil. Hydrogenated Castor Oil Cetyl the hydrogenation product of the esters formed by the reaction of castor oil with cetyl skin cond. agent-misc.; hair cond. Esters alcohol. The hydrogenation product of the mixture of esters obtained from the agent; binder; emul. stab. reaction of cetyl alcohol with castor oil. Hydrogenated Castor Oil Stearyl the hydrogenation product of the esters formed by the reaction of castor oil and skin cond. agent-misc.; hair cond. Esters stearyl alcohol. The hydrogenation product of the mixture of esters obtained from agent; binder; emul. stab. the reaction of stearyl alcohol with castor oil. Hydrogenated Ethylhexyl Olivate a mixture of esters produced by the reaction of ethylhexanol and Hydrogenated Olive skin cond. agent-emol. Oil. The mixture of esters obtained from the reaction of 2-ethylhexyl alcohol with hydrogenated olive oil. Hydrogenated Ethylhexyl the product of the transeserification of 2-ethylhexyl alcohol and sesame seed oil that skin cond. agent-emol.; binder Sesamate has been hydrogenated. The mixture of esters obtained from the reaction of 2-ethylhexyl alcohol with hydrogenated sesame seed oil. Hydrogenated Isocetyl Olivate the end-product of the controlled hydrogenation of the mixture of esters formed by skin cond. agent-misc.; binder; the reaction of isocetyl alcohol with olive acid. The hydrogenation product of the disp. agent; humectant mixture of esters obtained from the reaction of branched-chain cetyl alcohols with the fatty acids derived from olive acid.

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Table 5. Definitions and functions Ingredient/CAS No. Definition4 (italicized text generated by CIR) Function4 Hydrogenated Isopropyl Jojobate the end-product of the controlled hydrogenation of Isopropyl Jojobate. The skin cond. agent-oc. hydrogenation product of the mixture of esters obtained from the reaction of isopropyl alcohol with the fatty acids derived from Simmondsia Chinensis (Jojoba) Oil. Hydroxycetyl Isostearate the ester of hydroxycetyl alcohol and isostearic acid. The mixture of esters obtained skin cond. agent-emol. from the reaction of cetyl glycol with branched-chain stearic acids. Hydroxyoctacosanyl Hydroxy- the ester of hydroxyoctacosanyl alcohol and hydroxystearic acid. The ester obtained skin cond. agent-emol.; visc. incr. stearate from the reaction of 2-hydroxyoctacosanyl alcohol with 12-hydroxystearic acid. agent 93840-71-2 Isoamyl Laurate the ester of isoamyl alcohol and lauric acid. The ester obtained from the reaction of skin cond. agent-emol.; fragrance 6309-51-9 isoamyl alcohol with lauric acid. ingr. Isobutyl Myristate the ester of isobutyl alcohol and myristic acid. The ester obtained from the reaction skin cond. agent-emol. 25263-97-2 of isobutyl alcohol with myristic acid. Isobutyl Palmitate the ester of isobutyl alcohol and palmitic acid. The ester obtained from the reaction skin cond. agent-emol.; fragrance 110-34-9 of isobutyl alcohol with palmitic acid. ingr. Isobutyl Pelargonate the ester of isobutyl alcohol and Pelargonic Acid. The ester obtained from the skin cond. agent-emol.; fragrance 30982-03-7 reaction of isobutyl alcohol with nonanoic acid. ingr. Isobutyl Stearate the ester of isobutyl alcohol and stearic acid. The ester obtained from the reaction of skin cond. agent-emol. 646-13-9 isobutyl alcohol with stearic acid Isobutyl Tallowate the ester of isobutyl alcohol and Tallow Acid. The mixture of esters obtained from skin cond. agent-emol. 68526-50-1 the reaction of isobutyl alcohol with the fatty acids derived from tallow acid. Isocetyl Behenate the ester of Isocetyl Alcohol and behenic acid. The mixture of esters obtained from skin cond. agent-oc. 94247-28-6 the reaction of branched-chain cetyl alcohols with behenic acid. Isocetyl Ethylhexanoate the ester of isocetyl alcohol and 2-ethylhexanoic acid. The mixture of esters obtained skin cond. agent-emol. 125804-19-5 from the reaction of branched-chain cetyl alcohols with 2-ethylhexanoic acid. Isocetyl Isodecanoate the mixture of esters obtained from the reaction of isocetyl alcohol with a branched, skin cond. agent-emol. 129588-05-2 fatty acid, containing 10 carbons in the alkyl chain. The mixture of esters obtained from the reaction of branched-chain cety alcohols with branched-chain decanoic acids. Isocetyl Isostearate the ester of isocetyl alcohol and isostearic acid. The mixtures of esters obtained from skin cond. agent-emol. 52006-45-8 the reaction of branched-chain cetyl alcohols with branched-chain stearic acids. Isocetyl Laurate the ester of isocetyl alcohol and lauric acid. The mixture of esters obtained from the skin cond. agent-emol. 89527-28-6 reaction of branched-chain cetyl alcohols with lauric acid. Isocetyl Myristate the ester of Isocetyl Alcohol and myristic acid. The mixture of esters obtained from skin cond. agent-oc. 83708-66-1 the reaction of branched-chain cetyl alcohols with myristic acid. Isocetyl Palmitate the ester of Isocetyl Alcohol and palmitic acid. The mixture of esters obtained from skin cond. agent-emol. 127770-27-8 the reaction of branched-chain cetyl alcohols with palmitic acid. Isocetyl Stearate the ester of isocetyl alcohol and stearic acid. The mixture of esters obtained from the skin cond. agent-emol. 25339-09-7 reaction of branched-chain cetyl alcohols with stearic acid. Isodecyl Cocoate the ester of branched chain decyl alcohols and coconut acid. The mixture of esters skin cond. agent-emol. obtained from the reaction of branched-chain decyl alcohols with the fatty acids derived from coconut acid. Isodecyl Ethylhexanoate the ester of branched chain decyl alcohols and 2-ethylhexanoic acid. The mixture of skin cond. agent-emol. 89933-26-6; 34962-91-9 esters obtained from the reaction of branched-chain decyl alcohols with 2-ethylhexanoic acid. Isodecyl Hydroxystearate the ester of branched chain decyl alcohols and 12-hydroxystearic acid. The mixture skin cond. agent-emol. 29383-27-5; 59231-36-6 of esters obtained from the reaction of branched-chain decyl alcohols with 12-hydroxystearic acid. Isodecyl Isononanoate the ester of branched chain decyl alcohols and a branched chain nonanoic acid. The skin cond. agent-emol. 41395-89-5; 59231-35-5 mixture of esters obtained from the reaction of branched-chain decyl alcohols with branched-chain nonanoic acids. Isodecyl Laurate the ester of branched chain decyl alcohols and lauric acid. The mixture of esters skin cond. agent-emol. 14779-93-2; 94247-10-6 obtained from the reaction of branched-chain decyl alcohols with lauric acid. Isodecyl Myristate the ester of branched chain decyl alcohols and myristic acid. The mixture of esters skin cond. agent-emol. 17670-91-6; 51473-24-6 obtained from the reaction of branched-chain decyl alcohols with myristic acid. Isodecyl Neopentanoate the ester of branched chain decyl alcohols and neopentanoic acid. The mixture of skin cond. agent-emol. 60209-82-7 esters obtained from the reaction of branched-chain decyl alcohols with neopentanoic acid. Isodecyl Oleate the ester of branched chain decyl alcohols and oleic acid. The mixture of esters skin cond. agent-emol. 59231-34-4 obtained from the reaction of branched-chain decyl alcohols with oleic acid. Isodecyl Palmitate the ester of branched chain decyl alcohols and palmitic acid. The mixture of esters skin cond. agent-emol. 14779-95-4; 59231-33-3 obtained from the reaction of branched-chain decyl alcohols with palmitic acid. Isodecyl Stearate the ester of branched decyl alcohols and stearic acid. The mixture of esters obtained skin cond. agent-emol. 31565-38-5 from the reaction of branched-chain decyl alcohols with stearic acid. Isohexyl Caprate the ester of capric acid and a branched chain, 6-carbon alcohol. The mixture of esters skin cond. agent-emol. obtained from the reaction of branched-chain hexyl alcohols with capric acid. Isohexyl Laurate the ester of a branched chain hexyl alcohol and lauric acid. The mixture of esters skin cond. agent-emol. 59219-73-7 obtained from the reaction of branched-chain hexyl alcohols with lauric acid. Isohexyl Neopentanoate the ester of isohexyl alcohol and neopentanoic acid that conforms to the formula. skin cond. agent-emol. 131141-70-3; 150588-62-8 The mixture of esters obtained from the reaction of branched-chain hexyl alcohols with neopentanoic acid.

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Table 5. Definitions and functions Ingredient/CAS No. Definition4 (italicized text generated by CIR) Function4 Isohexyl Palmitate the ester of a branched chain hexyl alcohol and palmitic acid. The mixture of esters skin cond. agent-emol. 55194-91-7; 59219-72-6 obtained from the reaction of branched-chain hexyl alcohols with palmitic acid. Isolauryl Behenate the ester of branched chain dodecyl alcohols and behenic acid. The mixture of esters skin cond. agent-oc. obtained from the reaction of branched-chain lauryl alcohols with behenic acid. Isononyl Isononanoate the ester of a branched chain nonyl alcohol with a branched chain nonanoic acid. skin cond. agent-emol. 42131-25-9; 59219-71-5 The mixture of esters obtained from the reaction of branched-chain nonyl alcohols with branched-chain nonanoic acids. Isooctyl Caprylate/Caprate the ester of a branched chain octyl alcohol with a mixture of caprylic and capric skin cond. agent-emol.; acids. The mixture of esters obtained from the reaction of branched-chain octyl antioxidant alcohols with a mixture of caprylic and capric acids. Isooctyl Tallate the organic compound that conforms to the formula. The mixture of esters obtained skin cond. agent-emol.; plasticizer; from the reaction of branched-chain octyl alcohols with the fatty acids derived from solvent tall oil. Isopropyl Arachidate the ester of isopropyl alcohol and Arachidic Acid that conforms to the formula. The skin cond. agent-emol. 26718-90-1 ester obtained from the reaction of isopropyl alcohol with arachidic acid. Isopropyl Avocadate the ester of isopropyl alcohol and the fatty acids derived from avocado oil. The skin cond. agent-emol. 90990-05-9 mixture of esters obtained from the reaction of isopropyl alcohol with the fatty acids derived from avocado oil. Isopropyl Babassuate the ester of isopropyl alcohol and the fatty acids derived from Orbignya Oleifera skin cond. agent-emol.; binder; (Babassu) Oil. The mixture of esters obtained from the reaction of isopropyl alcohol disp. agent-non-surf; emul. stab. with the fatty acids derived from Orbignya Oleifera (Babassu) Oil. Isopropyl Behenate the ester of isopropyl alcohol and Behenic Acid. The ester obtained from the skin cond. agent-emol. 26718-95-6 reaction of isopropyl alcohol with behenic acid. Isopropyl Hydroxystearate the ester of isopropyl alcohol and 12-hydroxystearic acid. The ester obtained from skin cond. agent-emol. the reaction of isopropyl alcohol with 12-hydroxystearic acid. Isopropyl Isostearate the ester of isopropyl alcohol and isostearic acid. The mixture of esters obtained skin cond. agent-emol.; binder 31478-84-9; 68171-33-5 from the reaction of isopropyl alcohol with branched-chain stearic acids. Isopropyl Jojobate the ester of isopropyl alcohol and the acids derived from Simmondsia Chinensis skin cond. agent-emol. (Jojoba) Oil. The mixture of esters obtained from the reaction of isopropyl alcohol with the fatty acids derived from Simmondsia Chinensis (Jojoba) Oil. Isopropyl Laurate the ester of isopropyl alcohol and lauric acid. The ester obtained from the reaction skin cond. agent-emol.; binder; 10233-13-3 of isopropyl alcohol with lauric acid. fragrance ingr. Isopropyl Linoleate the ester of isopropyl alcohol and linoleic acid. The ester obtained from the reaction skin cond. agent-emol. 22882-95-7 of isopropyl alcohol with linoleic acid. Isopropyl Myristate the ester of isopropyl alcohol and myristic acid. The ester obtained from the reaction skin cond. agent-emol.; binder; 110-27-0 of isopropyl alcohol with myristic acid. fragrance ingr. Isopropyl Oleate the ester of isopropyl alcohol and oleic acid. The ester obtained from the reaction of skin cond. agent-emol.; binder 112-11-8; 17364-07-7 isopropyl alcohol with oleic acid. Isopropyl Palmitate the ester of isopropyl alcohol and palmitic acid. The ester obtained from the reaction skin cond. agent-emol.; binder; 142-91-6 of isopropyl alcohol with myristic acid. fragrance ingr. Isopropyl Ricinoleate the ester of isopropyl alcohol and ricinoleic acid. The ester obtained from the skin cond. agent-emol. 71685-99-9 reaction of isopropyl alcohol with ricinoleic acid. Isopropyl Sorbate the ester of isopropyl alcohol and sorbic acid. The ester obtained from the reaction of preservative 44987-75-9; 55584-26-4 isopropyl alcohol with sorbic acid. Isopropyl Stearate the ester of isopropyl alcohol and stearic acid. The ester obtained from the reaction skin cond. agent-emol.; binder 112-10-7 of isopropyl alcohol with stearic acid. Isopropyl Tallowate the ester of isopropyl alcohol and Tallow Acid. The mixture of esters obtained from skin cond. agent-emol.; binder the reaction of isopropyl alcohol with the fatty acids derived from tallow acid. Isostearyl Avocadate the ester of Isostearyl Alcohol and the acids derived from avocado oil. The mixture skin cond. agent-emol. 90990-06-0 of esters obtained from the reaction of branched-chain stearic alcohols with the fatty acids derived from avocado oil. Isostearyl Behenate the ester of Isostearyl Alcohol and Behenic Acid. The mixture of esters obtained skin cond. agent-oc. 125804-16-2 from the reaction of branched-chain stearic alcohols with behenic acid. Isostearyl Erucate the ester of Isostearyl Alcohol and erucic acid. The mixture of esters obtained from skin cond. agent-oc. 84605-10-7 the reaction of branched-chain stearyl alcohols with erucic acid. Isostearyl Ethylhexanoate the ester of isostearyl alcohol and 2-ethylhexanoic acid. The mixture of esters skin cond. agent-emol. 69247-83-2 obtained from the reaction of branched-chain stearyl alcohols with 2-ethylhexanoic acid. Isostearyl Hydroxystearate the ester of isostearyl alcohol and hydroxystearic acid. The mixture of esters skin cond. agent-emol. 162888-05-3; 338450-67-2 obtained from the reaction of branched-chain stearyl alcohols with 12-hydroxystearic acid. Isostearyl Isononanoate the ester of isostearyl alcohol and isononanoic acid. The mixture of esters obtained skin cond. agent-emol. 90967-66-1; 163564-45-2 from the reaction of branched-chain stearyl alcohols with branched-chain nonanoic acids. Isostearyl Isostearate the ester of Isostearyl Alcohol and Isostearic Acid. The mixture of esters obtained skin cond. agent-emol.; binder 41669-30-1 from the reaction of branched-chain stearyl alcohols with branched-chain stearic acids. Isostearyl Laurate the ester of isostearyl alcohol and lauric acid. The mixture of esters obtained from skin cond. agent-emol. the reaction of branched-chain stearyl alcohols with lauric acid Isostearyl Linoleate the ester of isostearyl alcohol and linoleic acid. The mixture of esters obtained from skin cond. agent-emol. 127358-80-9 the reaction of branched-chain stearyl alcohols with linoleic acid.

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Table 5. Definitions and functions Ingredient/CAS No. Definition4 (italicized text generated by CIR) Function4 Isostearyl Myristate the ester of isostearyl alcohol and myristic acid. The mixture of esters obtained from skin cond. agent-emol.; binder 72576-81-9 the reaction of branched-chain stearyl alcohols with myristic acid. Isostearyl Neopentanoate the ester of isostearyl alcohol and neopentanoic acid. The mixture of esters obtained skin cond. agent-emol.; binder 58958-60-4 from the reaction of branched-chain stearyl alcohols with neopentanoic acid. Isostearyl Palmitate the ester of Isostearyl Alcohol and palmitic acid. The mixture of esters obtained skin cond. agent-emol.; binder 69247-83-2; 72576-80-8 from the reaction of branched-chain stearyl alcohols with palmitic acid. Isotridecyl Isononanoate the ester of isotridecyl alcohol and isononanoic acid. The mixture of esters obtained skin cond. agent-emol. 42131-27-1; 59231-37-7 from the reaction of branched-chain tridecyl alcohols with branched-chain nonanoic acids. Isotridecyl Laurate the ester of Isotridecyl Alcohol and lauric acid that conforms generally to the skin cond. agent-oc.; hair cond. 94134-83-5 formula. The mixture of esters obtained from the reaction of branched-chain tridecyl agent alcohols with lauric acid. Isotridecyl Myristate The ester of myristic acid and isotridecyl alcohol. The mixture of esters obtained skin cond. agent-oc.; hair cond. 96518-24-0 from the reaction of branched-chain tridecyl alcohols with myristic acid. agent Isotridecyl Stearate the monoester of isotridecyl alcohol and stearic acid that conforms to the formula. skin cond. agent-emol. 31565-37-4 The mixture of esters obtained from the reaction of branched-chain tridecyl alcohols with stearic acid. Lauryl Behenate the ester of lauryl alcohol and behenic acid. The ester obtained from the reaction of skin cond. agent-oc. 42233-07-8 lauryl alcohol with behenic acid. Lauryl Cocoate the ester of lauryl alcohol and the fatty acids derived from coconut oil. The mixture skin cond. agent-emol.; skin cond. of esters obtained from the reaction of lauryl alcohol with the fatty acids derived agent-oc. from coconut oil. Lauryl Ethylhexanoate the ester of lauryl alcohol and 2-ethylhexanoic acid. The ester obtained from the skin cond. agent-emol. 56078-38-7 reaction of lauryl alcohol with 2-ethylhexanoic acid. Lauryl Isostearate the ester of lauryl alcohol and Isostearic Acid. The mixture of esters obtained from skin cond. agent-emol. 93803-85-1 the reaction of lauryl alcohol with branched-chain stearic acids. Lauryl Laurate the ester of Lauryl Alcohol and Lauric Acid. The ester obtained from the reaction of skin cond. agent-misc.; binder; 13945-76-1 lauryl alcohol with lauric acid. emul. stab.; hair cond. agent; opacifying agent Lauryl Myristate the ester of lauryl alcohol and myristic acid. The ester obtained from the reaction of skin cond. agent-oc.; hair cond. 2040-64-4 lauryl alcohol with myristic acid. agent Lauryl Oleate ester of lauryl alcohol and oleic acid that conforms to the formula. The ester skin cond. agent-oc. 36078-10-1 obtained from the reaction of lauryl alcohol with oleic acid. Lauryl Palmitate the ester of lauryl alcohol and palmitic acid. The ester obtained from the reaction of skin cond. agent-oc. 42232-29-1 lauryl alcohol with palmitic acid. Lauryl Stearate the ester of lauryl alcohol and stearic acid. The ester obtained from the reaction of skin cond. agent-oc. 5303-25-3 lauryl alcohol with stearic acid. Lignoceryl Erucate the ester of lignoceryl alcohol and erucic acid. The ester obtained from the reaction skin cond. agent-emol. of lignoceryl alcohol with erucic acid. Myristyl Ethylhexanoate ester of myristyl alcohol and 2-ethylhexanoic acid that conforms to the formula. The skin cond. agent-emol. 72201-45-7 ester obtained from the reaction of myristyl alcohol with 2-ethylhexanoic acid. Myristyl Isostearate the ester of myristyl alcohol and isostearic acid. The mixture of esters obtained from skin cond. agent-emol. 94247-26-4 the reaction of myristyl alcohol with branched-chain stearic acids. Myristyl Laurate the ester of myristyl alcohol and lauric acid. The ester obtained from the reaction of surf-emulsifying agent 22412-97-1 myristyl alcohol with lauric acid. Myristyl Myristate the ester of myristyl alcohol and myristic acid. The ester obtained from the reaction skin cond. agent-oc. 3234-85-3 of myristyl alcohol with myristic acid Myristyl Neopentanoate the ester of myristyl alcohol and neopentanoic acid. The ester obtained from the skin cond. agent-emol. 144610-93-5 reaction of myristyl alcohol with neopentanoic acid. Myristyl Stearate the ester of myristyl alcohol and stearic acid. The ester obtained from the reaction of skin cond. agent-oc. 17661-50-6 myristyl alcohol and stearic acid. Octyldecyl Oleate the ester of octyldecanol and oleic acid. The ester obtained from the reaction of 2- skin cond. agent-emol. octyldecanol with oleic acid. Octyldodecyl Avocadoate the ester of Octyldodecanol and the fatty acids derived from avocado oil. The skin cond. agent-emol. mixture of esters obtained from the reaction of 2-octyldodecanol with the fatty acids derived from avocado oil. Octyldodecyl Beeswax the ester of Octyldodecanol and Beeswax Acid. The mixture of esters obtained from skin cond. agent-emol. the reaction of 2-octyldodecanol with a mixture of straight-chain fatty acids, containing 24 to 36 carbons in alkyl chain length (beeswax acid). Octyldodecyl Behenate the ester of Octyldodecanol and behenic acid that conforms to the formula. The ester skin cond. agent-oc. 125804-08-2 obtained from the reaction of 2-octyldodecanol with behenic acid. Octyldodecyl Cocoate the ester of octyldodecanol and coconut acid. The mixture of esters obtained from skin cond. agent-emol. the reaction of 2-octyldodecanol and the fatty-acids derived from coconut acid. Octyldodecyl Erucate the ester of octyldodecanol and erucic acid. The ester obtained from the reaction of skin cond. agent-oc. 88103-59-7 2-octyldodecanol with erucic acid. Octyldodecyl Ethylhexanoate the ester of Octyldodecanol and 2-ethylhexanoic acid. The ester obtained from the skin cond. agent-emol. 69275-04-3 reaction of 2-octyldodecanol and 2-ethylhexanoic acid. Octyldodecyl Hydroxystearate the ester of Octyldodecanol and 12-hydroxystearic acid. The ester obtained from the skin cond. agent-oc. 308122-33-0 reaction of 2-octyldodecanol and 12-hydroxystearic acid. Octyldodecyl Isostearate the ester of Octyldodecanol and isostearic acid. The mixture of esters obtained from skin cond. agent-oc. 93803-87-3 the reaction of 2-octyldodecanol with isostearic acid.

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Table 5. Definitions and functions Ingredient/CAS No. Definition4 (italicized text generated by CIR) Function4 Octyldodecyl Meadowfoamate the ester of Octyldodecanol and the fatty acids derived from Limnanthes Alba skin cond. agent-oc. (Meadowfoam) Seed Oil. The mixture of esters obtained from the reaction of 2-octyldodecanol with the fatty acids derived from Limnanthes Alba (Meadowfoam) Seed Oil. Octyldodecyl Myristate the ester of octyldodecanol and myristic acid. The ester obtained from the reaction of skin cond. agent-oc. 22766-83-2; 83826-43-1 2-octyldodecanol with myristic acid. Octyldodecyl Neodecanoate the ester of Octyldodecanol and neodecanoic acid. The ester obtained from the skin cond. agent-emol. 1004272-41-6 reaction of 2-octyldodecanol with neodecanoic acid. Octyldodecyl Neopentanoate the ester of Octyldodecanol and neopentanoic acid. The ester obtained from the skin cond. agent-emol. 158567-66-9 reaction of 2-octyldodecanol with neopentanoic acid. Octyldodecyl Octyldodecanoate the ester of Octyldecanol and octyldodecanoic acid. The ester obtained from the skin cond. agent-oc. reaction of 2-octyldecanol with 2-octyldodecanoic acid. Octyldodecyl Oleate the ester of Octyldodecanol and oleic acid. The ester obtained from the reaction of skin cond. agent-oc. 22801-45-2 2-octyldodecanol with oleic acid. Octyldodecyl Olivate the ester of Octyldodecanol and the fatty acids derived from Olea Europaea (Olive) skin cond. agent-emol.; skin cond. 22801-45-2 Oil. The ester obtained from the reaction of 2-octyldodecanol with the fatty acids agent-oc.; binder; film former; hair derived from Olea Europaea (Olive) Oil. cond. agent; slip modifier Octyldodecyl Ricinoleate the ester of octyldodecanol and ricinoleic acid. The ester obtained from the reaction hair cond. agent; shampoo 79490-62-3; 125093-27-8 of 2-octyldodecanol with ricinoleic acid. Octyldodecyl Safflowerate the ester of Octyldodecanol and the fatty acids derived from Carthamus Tinctorius skin cond. agent-emol. (Safflower) Oil. The ester obtained from the reaction of 2-octyldodecanol with the fatty acids derived from Carthamus Tinctorius (Safflower) Oil. Octyldodecyl Stearate the ester of octyldodecanol and stearic acid. The ester obtained from the reaction of skin cond. agent-oc. 22766-82-1 2-octyldodecanol with stearic acid. Oleyl Arachidate the ester of oleyl alcohol and Arachidic Acid. The ester obtained from the reaction of skin cond. agent-oc. 22393-96-0; 156952-79-3 oleyl alcohol with arachidic acid. Oleyl Erucate the ester of Oleyl Alcohol and erucic acid. The ester obtained from the reaction of skin cond. agent-oc. 17673-56-2; 143485-69-2 oleyl alcohol with erucic acid. Oleyl Linoleate the ester of Oleyl Alcohol and Linoleic Acid. The ester obtained from the reaction of skin cond. agent-oc.; hair cond. 17673-59-5 oleyl alcohol with linoleic acid. agent Oleyl Myristate the ester of oleyl alcohol and myristic acid. The ester obtained from the reaction of skin cond. agent-oc.; hair cond. 22393-93-7 oleyl alcohol with myristic acid. agent Oleyl Oleate the ester of Oleyl Alcohol and oleic acid. The ester obtained from the reaction of skin cond. agent-emol.; skin cond. 3687-45-4; 17363-94-9 oleyl alcohol with oleic acid. agent-emol. Oleyl Stearate the ester of oleyl alcohol and stearic acid. The ester obtained from the reaction of skin cond. agent-oc.; hair cond. 33057-39-5; 17673-50-6 oleyl alcohol with stearic acid. agent Propylheptyl Caprylate the organic compound that conforms to the formula. The ester obtained from the skin cond. agent-emol. 868839-23-0 reaction of 2-propylheptanol with caprylic acid. Stearyl Beeswax the ester of Stearyl Alcohol and Beeswax Acid. The mixture of esters obtained from skin cond. agent-oc. 42233-11-4 the reaction of stearyl alcohol with a mixture of straight-chain fatty acids, containing 24 to 36 carbons in alkyl chain length (beeswax acid). Stearyl Behenate the ester of stearyl alcohol and behenic acid. The ester obtained from the reaction of skin cond. agent-oc. 24271-12-3 stearyl alcohol with behenic acid. Stearyl Caprylate the ester of stearyl alcohol and caprylic acid. The ester obtained from the reaction of skin cond. agent-oc. 18312-31-7 stearyl alcohol with caprylic acid. Stearyl Erucate the ester of stearyl alcohol and erucic acid. The ester obtained from the reaction of visc. incr. agent-nonaq. 86601-84-5; 96810-34-3 stearyl alcohol with erucic acid. Stearyl Ethylhexanoate the ester of stearyl alcohol and 2-ethylhexanoic acid. The ester obtained from the skin cond. agent-oc. 59130-70-0 reaction of stearyl alcohol with 2-ethylhexanoic acid. Stearyl Heptanoate the ester of stearyl alcohol and heptanoic acid. The ester obtained from the reaction skin cond. agent-oc. 66009-41-4 of stearyl alcohol with heptanoic acid. Stearyl Linoleate the ester of stearyl alcohol and linoleic acid that conforms to the formula. The ester skin cond. agent-oc.; visc. incr. 17673-53-9 obtained from the reaction of stearyl alcohol with linoleic acid. agent-nonaq. Stearyl Olivate the ester of stearyl alcohol and the fatty acids derived from Olea Europaea (Olive) skin cond. agent-emol.; surf- Oil. The ester obtained from the reaction of stearyl alcohol with the fatty acids emulsifying agent derived from Olea Europaea (Olive) Oil. Steary Palmitate the ester of stearyl alcohol and palmitic acid. The ester obtained from the reaction of skin cond. agent-misc.; hair cond. 2598-99-4 stearyl alcohol with palmitic acid. agent; binder; emul. stab; humectant; film former; opacifying agent Stearyl Stearate the ester of stearyl alcohol and stearic acid. The ester obtained from the reaction of skin cond. agent-oc.; visc. incr. 2778-96-3 stearyl alcohol with stearic acid. agent-nonaq. Tetradecyleicosyl Stearate the ester of Myristyleicosanol and stearic acid. The ester obtained from the reaction skin cond. agent-oc. of myristyleicosanol with stearic acid. Tetradecyloctadecyl Behenate the ester of Tetradecyloctadecanol and Behenic Acid. The ester obtained from the skin cond. agent-oc.; binder; emul. reaction of tetradecyloctadecanol with behenic acid. stab; film former; opacifying agent Tetradecyloctadecyl the organic compound that conforms to the formula. The ester obtained from the skin cond. agent-emol. Hexyldecanoate reaction of 2-tetradecyloctyldecanol with 2-hexyldecanoic acid. 93982-00-4 Tetradecyloctadecyl Myristate the ester of tetradecyloctadecanol and myristic acid. The ester obtained from the skin cond. agent-oc.; binder; emul. reaction of 2-tetradecyloctyldecanol with myristic acid. stab; film former; opacifying agent Tetradecyloctadecyl Stearate the ester of Tetradecyloctadecanol and stearic acid. The ester obtained from the skin cond. agent-oc.; binder; emul. reaction of 2-tetradecyloctadecanol with stearic acid. stab; film former; opacifying agent

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Table 5. Definitions and functions Ingredient/CAS No. Definition4 (italicized text generated by CIR) Function4 Tetradecylpropionates an isomeric mixture of esters consisting chiefly of 2-tetradecylproprionate, 3- skin cond. agent-emol.; solvent tetradecylproprionate, and 4-tetradecylproprionate. The mixture of esters obtained from the reaction of a mixture of 2-, 3-, and 4-tetradecanols with propionic acid. Tridecyl Behenate the ester of Tridecyl Alcohol and Behenic Acid. The ester obtained from the reaction skin cond. agent-oc. 42233-08-9 of tridecyl alcohol with behenic acid. Tridecyl Cocoate the ester of tridecyl alcohol and coconut acid. The mixture of esters obtained from skin cond. agent-oc. the reaction of tridecyl alcohol with the fatty acids derived from coconut acid. Tridecyl Erucate the ester of Tridecyl Alcohol and erucic acid. The ester obtained from the reaction of skin cond. agent-oc. 131154-74-0; 221048-36-8 tridecyl alcohol with erucic acid. Tridecyl Ethylhexanoate the ester of Tridecyl Alcohol and 2-ethylhexanoic acid. The ester obtained from the skin cond. agent-emol. reaction of tridecyl alcohol with 2-ethylhexanoic acid. Tridecyl Isononanoate the ester of Tridecyl Alcohol and isononanoic acid that conforms to the formula. The skin cond. agent-emol. 125804-18-4 ester of tridecyl alcohol and branched-chain nonanoic acids. Tridecyl Laurate the ester of tridecyl alcohol and lauric acid that conforms to the formula. The ester skin cond. agent-oc. 36665-67-5 obtained from the reaction of tridecyl alcohol with lauric acid. Tridecyl Myristate the ester of tridecyl alcohol and myristic acid. The ester obtained from the reaction skin cond. agent-oc. 36617-27-3 of tridecyl alcohol with myristic acid. Tridecyl Neopentanoate the ester of Tridecyl Alcohol and neopentanoic acid. The ester obtained from the skin cond. agent-emol. 106436-39-9; 105859-93-6 reaction of tridecyl alcohol with neopentanoic acid. Tridecyl Stearate the ester of Tridecyl Alcohol and stearic acid. The ester obtained from the reaction skin cond. agent-emol. 31556-45-3 of tridecyl alcohol with stearic acid. Abbreviations: cond. – conditioning; disp. – dispersing; emol. – emollient; emul. – emulsion; incr. – increasing; ingr. – ingredient; misc. – miscellaneous; nonaq. – non-aqueous; nonsurf – non-surfactant; oc. – occlusive; solub. – solubilizing; stab. – stabilizer; surf. – surfactant; visc. – viscosity

Table 6. Methods of Manufacture Ingredient Method of Manufacture Reference 32 Arachidyl Propionate manufactured as a mixture of the esters of the C18 – C28 fatty alcohols, of which C20 fatty alcohol ester is the major constituent Butyl Oleate reaction of butanol and oleic acid in the presence of dihydrogen phosphate 67 prepared from n-butanol and oleic acid by heating, with sulfuric acid as a catalyst 68,69 esterification of oleic acid with butyl alcohol in n-hexane in the presence of the macroporous sulfonic resin K2411 70 synthesized with Candida antarctica lipase catalyst or using a sodium alcoholate catalyst 2 esterification of oleic acid with butanol in the presence of p-toluene sulfonic acid 71 lipase-catalyzed oleic acid esterification by n-butyl alcohol in almost non-aqueous media without an organic solvent 72 Butyl Myristate derived from the esterification of myristic aci and butyl alcohol in the presence of an acid catalsty 35 Butyl Stearate the esterification of stearic acid with butyl alcohol; the reaction products are refined either by catalyst neutralization, 37 vacuum distillation, or various decolorization-deodorization techniques to remove traces of alcohol Cetearyl Ethylhexanoate commercially prepared by catalytic esterification with removal by azeotropic distillation; also prepared by blending cetyl 38 octanoate and stearyl octanoate in a weight ratio of 7:2 Cetyl Behenate esterification of behenic acid with cetyl alcohol using n-butyl benzene as the solvent and tetra n-butyl titanate as the 73 catalyst Cetyl Oleate cetyl alcohol and oleic acid were dissolved in benzene and heated, using sulfuric acid as a catalyst; the mixture was then 16 washed, the benzene filtered and removed by vacuum distillation, and the ester separated twice by distillation esterification of oleic acid with cetyl alcohol in n-hexane in the presence of p-toluene sulfonic acid 70 lipase-catalyzed oleic acid esterification by cetyl alcohol in almost non-aqueous media without an organic solvent 72 Cetyl Stearate the esterification of stearic acid with cetyl alcohol; the reaction products are refined either by catalyst neutralization, 37 vacuum distillation, or various decolorization-deodorization techniques to remove traces of alcohol Ethylhexyl Ethylhexanoate direct esterification reaction of 2-ethylhexanoic acid and 2-ethylhexanol in n-hexane as solvent and Novozym 435 (a 74 commercial immobilized lipase from Candida antartica) as catalyst Ethylhexyl Laurate co-produced by the lipase-catalyzed acylation of racemic alcohol and vinyl laurate in the production of (R)-2-ethylhexanol 75 Ethylhexyl Oleate synthesized with Candida antarctica lipase catalyst or using a sodium alcoholate catalyst 2

Ethylhexyl Stearate the esterification of stearic acid with octyl alcohol; the reaction products are refined either by catalyst neutralization, 37 vacuum distillation, or various decolorization-deodorization techniques to remove traces of alcohol Isobutyl Stearate the esterification of stearic acid with isobutyl alcohol; the reaction products are refined either by catalyst neutralization, 37 vacuum distillation, or various decolorization-deodorization techniques to remove traces of alcohol Isocetyl Myristate the esterification of isocetyl alcohol and myristic acid 34 Isocetyl Stearate the esterification of stearic acid with isocetyl alcohol; the reaction products are refined either by catalyst neutralization, 37 vacuum distillation, or various decolorization-deodorization techniques to remove traces of alcohol can be made by heating with or without acid catalyst Isopropyl Arachidate arachidic acid was treated with with isopropyl alcohol in large molar excess, p-toluene sulfonic acid was the catalyst 76 Isopropyl Laurate lauric acid was treated with with isopropyl alcohol in large molar excess, p-toluene sulfonic acid was the catalyst 76 Isopropyl Myristate commercially produced by distillation, which is preceded by the esterification of myristic acid and isopropanol, in the 48 presence of an acid catalyst

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Table 6. Methods of Manufacture Ingredient Method of Manufacture Reference Isopropyl Oleate esterification of oleic acid with isopropyl alcohol in n-hexane in the presence of K2411 70 synthesized with Candida antarctica lipase catalyst or using a sodium alcoholate catalyst 2 Isopropyl Stearate the esterification of stearic acid with isopropyl alcohol; the reaction products are refined either by catalyst neutralization, 37 vacuum distillation, or various decolorization-deodorization techniques to remove traces of alcohol Isostearyl Neopentanoate prepared by esterifying isostearyl alcohol with neopentanoic acid in the presence of a catalyst 49 Lauryl Behenate esterification of behenic acid with lauryl alcohol using n-butyl benzene as the solvent and tetra n-butyl titanate as the 73 catalyst Lauryl Oleate esterification of oleic acid with lauryl alcohol in n-hexane in the presence of p-toluene sulfonic acid 70 synthesized with Candida antarctica lipase catalyst or using a sodium alcoholate catalyst Lauryl Palmitate lipase-catalyzed esterification of palmitic acid and lauryl alcohol using Novozym 435 as the biocatalyst 77 Myristyl Laurate the fatty acid chloride was reacted with myristic acid in the presence of pyridine, using diethyl ether as the solvent 78 Myristyl Myristate produced by the esterification of myristic acid and myristyl alcohol in the presence of an acid catalyst 48 Myristyl Stearate the esterification of stearic acid with myristyl alcohol; the reaction products are refined either by catalyst neutralization, 37 vacuum distillation, or various decolorization-deodorization techniques to remove traces of alcohol Octyldodecyl Myristate the esterification of myristic acid with 2-octyl dodecanol, manufactured from vegetable sources 34 Oleyl Arachidate the fatty acid chloride was reacted with oleic acid in the presence of pyridine, using diethyl ether as the solvent 78 Oleyl Oleate the fatty acid chloride was reacted with oleic acid in the presence of pyridine, using diethyl ether as the solvent 78 lipase-catalyzed oleic acid esterification by oleyl alcohol in almost non-aqueous media without an organic solvent 72 synthesized with Candida antarctica lipase catalyst or using a sodium alcoholate catalyst 2 Oleyl Stearate the fatty acid chloride was reacted with oleic acid in the presence of pyridine, using diethyl ether as the solvent 78

Table 7. Chemical and physical properties Property Description Reference Arachidyl Behenate molecular weight 621.12 79 boiling point 648.7°C (760 Torr) (calculated) 79 density 0.856 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 20.146 (25°C) (calculated) 79 Arachidyl Erucate molecular weight 619.10 79 boiling point 608.3°C (760 Torr) (calculated) 79 density 0.898 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 16.353 (25°C) (calculated) 79 Arachidyl Propionate characteristics soft, waxy, amber-colored solid with a slight characteristic odor 32 melting point 36-38°C 32 boiling point 224°C 32 specific gravity 0.83 32 solubility soluble in mineral oil 32 insoluble in water Batyl Stearate molecular weight 611.03 79 boiling point 656.9°C (760 Torr) (calculated) 79 density 0.856 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 20.146 (25°C) (calculated) 79 pKa 14.08 (most acidic temperature: 25°C) (calculated) 79 Behenyl Behenate molecular weight 649.18 80 Behenyl Erucate molecular weight 647.15 79 boiling point 669.1°C (760 Torr) (calculated) 79 density 0.860 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 20.755 (25°C) (calculated) 79 Butyl Myristate form colorless oily liquid 35 boiling point 167-197°C (5 mm Hg) 35 specific gravity 0.850 – 0.858 (25°C) 35 solubility soluble in acetone, castor oil, chloroform, methanol, mineral oil, and toluene 35 insoluble in water Butyl Oleate appearance and form mobile, yellow, oily liquid molecular weight 338.57 67 melting point -31.7°C 2 -35.5°C 71 boiling point 235-45 °C 67 density 0.870 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 9.547 (25°C) (calculated) 79 56

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Table 7. Chemical and physical properties Property Description Reference Butyl Stearate characteristics stable, colorless, oily liquid 37 molecular weight 340.57 37 melting point 16-20.5°C 37 boiling point 212-216°C 37 specific gravity 0.851-0.861 (20°/20°C) 37 refractive index 1.441 (25°C) 37 saponification value 146-177 37 solubility soluble in acetone, chloroform, ether, alcohol, ketones, ethyl acetate, aromatic and aliphatic hydrocarbons, fats, 37 waxes, mineral oils, and many plasticizers insoluble in water Caprylyl Butyrate molecular weight 200.32 79,80 melting point -55.6°C 81 boiling point 244.1°C 81 water solubility 5.81 mg/l (25°C) (estimated) 81 density 0.870 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 4.861 (25°C) (calculated) 79 Caprylyl Caprylate molecular weight 256.42 79,80 melting point -18.1°C 81 boiling point 306.8°C 81 water solubility 0.112 mg/l (25°C) (estimated) 81 density 0.865 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 6.899 (25°C) (calculated) 79 Cetearyl Ethylhexanoate characteristics clear, oily liquid 38 specific gravity -4.0 – 1.0°C 38 refractive index 1.444 – 1.116 (20°C) 38 saponification value 135-160 38 Cetearyl Isononanoate form yellowish liquid 40 melting point <15°C 40 refractive index 1.445 – 1.450 40 density 0.854 – 8.858 g/ml 40 saponification value 140-146 40 solubility insoluble in water 40 Cetyl Behenate molecular weight 565.01 79 melting point 65°C 73 boiling point 569.4°C (760 Torr) (calculated) 79 density 0.857 g/cm3 (20°C; 760 Torr) (calculated) 79 specific gravity 0.8178 – 0.804 (70 - 100°C, respectively) 73 refractive index 1.441 – 1.433 (70 - 90°C, respectively) 73 log P 18.108 (25°C) (calculated) 79 Cetyl Caprylate form liquid 22 molecular weight 368.64 79,80 boiling point 414.2°C (760 Torr) (calculated) 79 density 0.860 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 10.975 (25°C) (calculated) 79 Cetyl Esters characteristics white to off-white, somewhat translucent solid with a crystalline structure and a faint odor 82 melting range 43-47°C 82 specific gravity 0.820-0.840 (50°C) 82 saponification value 109 - 120 82 solubility soluble in boiling alcohol, ether, chloroform, and fixed oils 82 insoluble in water and cold alcohol 82 composition mixture consisting of esters of primarily saturated fatty alcohols (C14 to C18) and saturated fatty acids (C14 to C18) Cetyl Ethylhexanoate form liquid 22 molecular weight 368.64 79,80 boiling point 407.2°C (760 Torr) (calculated) 79 density 0.859 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 10.819 (25°C) (calculated) 79 Cetyl Isononanoate molecular weight 382.66 40 log P 0.28 (calculated) 40 Cetyl Laurate molecular weight 424.74 79 melting point 40-41°C 83 boiling point 462.2°C (760 Torr) (calculated) 79 density 0.860 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 113.013 (25°C) (calculated) 79 57

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Table 7. Chemical and physical properties Property Description Reference Cetyl Myristoleate molecular weight 450.78 79 boiling point 519.6°C (calculated) 79 log P 14.005 (25°C) (calculated) 79 Cetyl Oleate molecular weight 506.89 80 melting point 25.5°C 84 saponification value 110.7 16 Cetyl Palmitate molecular weight 481 41 characteristics white, crystalline, wax-like substance 41 melting point 46 - 54°C 41 specific gravity 0.832 (25°C) 41 41 refractive index 1.4398 (nD70) solubility soluble in alcohol and ether 41 insoluble in water C32-36 Isoalkyl Stearate molecular weight 761.38 80 Decyl Cocoate characteristics almost odorless light yellow liquid 43 specific gravity 0.85 g/cm3 (25°C) 43 saponification value 155 -* 170 43 Decyl Laurate molecular weight 340.58 80 boiling point 388.9°C (760 Torr) (calculated) 79 log P 9.956 (25°C) (calculated) 79 Decyl Oleate characteristics light yellow liquid 3 molecular weight 422 3 specific gravity 0.855 – 0.865 3 saponification value 103-142 3 solubility soluble in alcohol 3 insoluble in water Decyl Palmitate molecular weight 396.69 79,80 melting point 30°C 85 boiling point 438.7°C (760 Torr) (calculated) 79 density 0.860 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 11.994 (25°C) (calculated) 79 Ethylhexyl Ethylhexanoate molecular weight 256.42 79 boiling point 288.3°C (760 Torr) (calculated) 79 density 0.863 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 6.587 (25°C) (calculated) 79 Ethylhexyl Hydroxystearate characteristics clear to slightly opalescent, yellow, oily liquid with a slight fatty odor 82 boiling point 490.6°C (760 Torr) (calculated) 79 specific gravity 0.889-0.895 (25°/25°C) 82 saponification value 140-160 82 solubility soluble in ethyl alcohol and corn oil 82 insoluble in water and propylene glycol log P 9.776 (25°C) (calculated) 79 Ethylhexyl Isononanoate molecular weight 270.45 40 log P 5.91 (calculated) 40 Ethylhexyl Isopalmitate form liquid 22 Ethylhexyl Laurate molecular weight 312.53 79,80 melting point -30°C 26 boiling point >250°C (1013 hPa) 26 124-126°C (0.1 mm Hg) 75 water solubility 1 mg/l (20°C) 26 density 0.86 g/cm3 (20°C) 26 log P 8.781 (25°C) (calculated) 79 Ethylhexyl Oleate molecular weight 394.67 79 melting point -2.9°C 2 boiling point 465.8°C (760 Torr) (calculated) 79 density 0.867 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 11.429 (25°C) (calculated) 79 Ethylhexyl Palmitate molecular weight 388 41 characteristics clear, colorless, practically odorless liquid 41 58

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Table 7. Chemical and physical properties Property Description Reference specific gravity 0.850 – 0.865 (25°C) 41 refractive index 1.445 – 1.4465 (25°C) 41 solubility soluble in acetone, castor oil, corn oil, chloroform, ethanol, and mineral oil 41 insoluble in water, glycerin, and propylene glycol Ethylhexyl Pelargonate molecular weight 270.45 40 density 0.864 ± 0.06 g/cm3 (20°C) 40 log P 7.432 (calculated) 40 Ethylhexyl Stearate molecular weight 396 37 Erucyl Erucate molecular weight 645.14 79 boiling point 668.1°C (760 Torr) (calculated) 79 density 0.865 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 20.346 (25°C) (calculated) 79 Erucyl Oleate molecular weight 589.03 79 boiling point 631.3 79 density 0.866 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 18.308 (25°C) (calculated) 79 Heptyl Undecylenate molecular weight 282.46 79,80 boiling point 351.0°C (760 Torr) (calculated) 79 density 0.871 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 7.510 (25°C) (calculated) 79

Heptylundecyl Hydroxystearate molecular weight 552.96 79 boiling point 607.3°C (760 Torr) (calculated) 79 density 0.885 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 14.870 (25°C) (calculated) 79 pKa 15.40 (most acidic temp: 25°C) 79 Hexyldecyl Laurate molecular weight 424.74 80 Hexyldecyl Oleate molecular weight 506.89 79,80 boiling point 563.6°C (760 Torr) (calculated) 79 density 0.863 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 15.505 (25°C) (calculated) 79 Hexyldecyl Palmitate molecular weight 480.85 80 Hexyl Laurate molecular weight 284.48 79,80 melting point -3.4°C 86 boiling point 130°C 86 density 0.864 g/cm3 (20°C; 760 Torr) (calculated) 79 refractive index 1.4382 86 log P 7.918 (25°C) (calculated) 79 Hydroxyoctacosanyl Hydroxystearate molecular weight 709.22 79,80 boiling point 311.8°C (760 Torr) (calculated) 79 density 0.864 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 7.253 (25°C) (calculated) 79 Isoamyl Laurate molecular weight 270.45 79,80 boiling point 631.3 79 density 0.866 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 18.308 (25°C) (calculated) 79 Isobutyl Palmitate molecular weight 312.53 79,80 boiling point 354.6°C (760 Torr) (calculated) 79 density 0.862 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 8.781 (25°C) (calculated) 79 Isobutyl Pelargonate molecular weight 214.34 40 density 0.867 ± 0.06 g/cm3 (20°C) 40 log P 5.307 (calculated) 40 Isobutyl Stearate characteristics a paraffinlike crystal substance a low temperature; a liquid at room temperature 37 molecular weight 340.57 37 melting point 20°C 37 saponification value 170-180 37 Isocetyl Myristate characteristics oily liquid with practically no odor 34 59

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Table 7. Chemical and physical properties Property Description Reference density 0.862 34 solubility soluble in most organic solvents 34 insoluble in water Isocetyl Ethylhexanoate form liquid 22 Isocetyl Isostearate form liquid 22 molecular weight 508.9 80 Isocetyl Palmitate form liquid 22 Isocetyl Stearate characteristics an oily, colorless or yellow liquid with practically no odor 37 molecular weight 508 37 specific gravity 0.8520-00.858 (25°/25°C) 37 refractive index 1.451-1.453 (25°C) 37 saponification value 110-118 37 solubility soluble in ethanol, isopropanol, mineral oil, castor oil, acetone, and ethyl acetate 37 insoluble in water, glycerin, and propylene glycol Isodecyl Isononanoate molecular weight 298.5 40 refractive index 1.437 – 1.439 (25°C) 40 specific gravity 0.852 – 0.858 (25°/25°C) 40 saponification value 175 – 192 40 log P 6.68 (calculated) 40 Isodecyl Laurate form colorless or pale yellow liquid 27 molecular weight 340.58 79 boiling point 374.2°C (760 Torr) (calculated) 79 density 0.860 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 9.644 (25°C) (calculated) 79 Isodecyl Neopentanoate molecular weight 242.40 80 Isodecyl Oleate molecular weight 422 3 saponification value 130-145 3 Isodecyl Palmitate molecular weight 396.69 79,80 boiling point 425.2°C (760 Torr) (calculated) 79 density 0.858 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 11.682 (25°C) (calculated) 79 Isodecyl Stearate molecular weight 424.74 80 Isohexyl Caprate molecular weight 256.42 79 boiling point 296.8°C (760 Torr) (calculated) 79 density 0.864 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 6.743 (25°C) (calculated) 79 Isohexyl Laurate characteristics pale yellow liquid with a coconut-like odor 82 molecular weight 284.48 79 boiling point 326.5°C (760 Torr) (calculated) 79 refractive index 1.439 - 1.442 (20°C) 82 specific gravity 0.843 -0.853 (25°/25°C) 82 saponification value 130 - 145 82 solubility soluble in most organic solvents 82 insoluble in water free fatty acid content 0.1% (max.) (as lauric acid) 82 log P 7.762 (25°C) (calculated) 79 Isohexyl Neopentanoate molecular weight 186.29 79 boiling point 193.2°C (760 Torr) (calculated) 79 density 0.870 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 3.941 (25°C) (calculated) 79 Isohexyl Palmitate characteristics light yellow liquid with a fatty-type odor 82 molecular weight 340.58 79 boiling point 381.5°C (760 Torr) (calculated) 79 refractive index 1.4433 - 1.4443 (20°C) 82 specific gravity 0.850 -0.860 (25°/25°C) 82 saponification value 165-171 82 solubility soluble in alcohol and mineral oil 82 insoluble in water and lower glycols and glycerin log P 9.800 (25°C) (calculated) 79

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Table 7. Chemical and physical properties Property Description Reference Isononyl Isononanaote molecular weight 284.48 40 refractive index 1.430 – 1.436 (25°C) 40 specific gravity 0.849 – 0.855 (25°/25°C) 40 saponification value 192 - 202 40 log P 6.27 (calculated) 40 Isopropyl Arachidate form white crystal 76 molecular weight 354.61 79 melting point 53-55°C 76 boiling point 394.4°C (760 Torr) (calculated) 79 density 0.860 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 10.310 (25°C) (calculated) 79 Isopropyl Behenate molecular weight 382.66 79 boiling point 419.6°C (760 Torr) (calculated) 79 density 0.859 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 11.329 (25°C) (calculated) 79 Isopropyl Isostearate form liquid 45 specific gravity 0.853 – 0.859 (25°C) 45 solubility soluble in acetone, ethyl acetate, isopropyl alcohol, and mineral oil 45 Isopropyl Laurate form yellow oil 76 molecular weight 242.40 79 boiling point 196°C 81 specific gravity 0.851-0.857 87 refractive index 1.427-1.433 (20°C) 87 solubility insoluble in water 87 solubility in 95% ethanol, 1 ml in 1 ml log P 6.234 (25°C) (calculated) 79 Isopropyl Linoleate molecular weight 322.53 79 boiling point 399.0°C (760 Torr) (calculated) 79 density 0.880 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 8.478 (25°C) (calculated) 79 Isopropyl Myristate characteristics colorless, almost odorless liquid with a bland taste 48 boiling point 192.6°C (20 mm Hg) 48 specific gravity 0.847 – 0.853 (25°C) 48 refractive index 1.432 – 1.430 (25°C) 48 solubility soluble in acetone, castor oil, chloroform, cottonseed oil, ethanol, ethyl acetate, mineral oil, and toluene 48 insoluble in water, glycerol, sorbitan, and propylene glycol Isopropyl Oleate molecular weight 324.54 80 melting point -33.4°C 2 boiling point 369.8°C (760 Torr) (calculated) 79 density 0.870 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 8.881 (25°C) (calculated) 79 Isopropyl Palmitate molecular weight 318 41 characteristics colorless, almost odorless, mobile liquid mixture of isopropyl esters consisiting of a minimum of 60% isopropyl 41 palmitate melting point 11°C 41 specific gravity 0.850 – 0.855 (25°C) 41 refractive index 1.4355 – 1.4375 (25°C) 41 solubility soluble in acetone, castor oil, chloroform, cottonseed oil, ethyl acetate, ethanol, and mineral oil 41 insoluble in water, glycerin, and propylene glycol Isopropyl Stearate form liquid at room temperature 37 molecular weight 326 37 Isopropyl Sorbate molecular weight 154.21 79 boiling point 200.0°C (760 Torr) (calculated) 79 density 0.916 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 2.770 (25°C) (calculated) 79 Isostearyl Ethylhexanoate form liquid 22 Isostearyl Hydroxystearate molecular weight 552.96 79 boiling point 607.3°C (760 Torr) (calculated) 79 density 0.885 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 14.870 (25°C) (calculated) 79

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Table 7. Chemical and physical properties Property Description Reference Isostearyl Isononanoate molecular weight 410.72 40 log P 10.02 calculated) 40 Isostearyl Isostearate molecular weight 536.96 80 log P 17.399 (calculated) 21 Isostearyl Neopentanoate form clear, slightly yellow liquid 49 molecular weight 348-390 49 refractive index 1.4485 – 1.4515 (25°C) 49 specific gravity 0.858 – 0.870 (25°C) 49 saponification value 144 – 161 49 solubility soluble in mineral oil, 95% ethanol, propylene glycol , isopropyl myristate, oleyl alcohol, peanut oil 49 insoluble in water, 80% ethanol, Isotridecyl Isononanoate molecular weight 340.58 40 refractive index 1.433 – 1.445 (25°C) 40 specific gravity 0.859 – 0.861 (25°/25°C) 40 saponification value 155 - 162 40 log P 7.94 (calculated) 40 Isotridecyl Laurate molecular weight 382.66 79 boiling point 419.6°C (760 Torr) (calculated) 79 density 0.859 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 11.329 (25°C) (calculated) 79 Isotridecyl Stearate molecular weight 466.82 80 Lauryl Behenate molecular weight 508.90 79 melting point 53°C 73 boiling point 528.4°C (760 Torr) (calculated) 79 specific gravity 0.8295 – 0.8137 (60 - 90°C, respectively) 73 refractive index 1.443 – 1.433 (60 - 80°C, respectively) 73 log P 16.070 (25°C) (calculated) 79 Lauryl Ethylhexanoate molecular weight 312.53 79 boiling point 354.6°C (760 Torr) (calculated) 79 density 0.862 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 8.781 (25°C) (calculated) 79 Lauryl Laurate molecular weight 368.64 79 melting point 27°C 88 boiling point 226°C 88 density 0.860 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 10.975 (25°C) (calculated) 79 Lauryl Oleate molecular weight 485.75 79 melting point 14.5°C 89 18.4°C 2 boiling point 519.6°C (760 Torr) (calculated) 79 density 0.865g/cm3 (20°C; 760 Torr) (calculated) 79 log P 13.623 (25°C) (calculated) 79 Lauryl Palmitate molecular weight 424.74 79 boiling point 462.2°C (760 Torr) (calculated) 79 density 0.859 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 13.013 (25°C) (calculated) 79 Lauryl Stearate molecular weight 452.08 79 boiling point 484.9°C (760 Torr) (calculated) 79 density 0.858 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 14.032 (25°C) (calculated) 79 Myristyl Ethylhexanoate molecular weight 340.58 79 boiling point 381.5°C (760 Torr) (calculated) 79 density 0.861 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 9.800 (25°C) (calculated) 79 Myristyl Laurate molecular weight 396.69 79 boiling point 438.7°C (760 Torr) (calculated) 79 density 0.860 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 11.994 (25°C) (calculated) 79 Myristyl Myristate melting point 37-39°C 48 62

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Table 7. Chemical and physical properties Property Description Reference saponification value 119 - 129 48 Myristyl Neopentanoate molecular weight 298.50 79 boiling point 332.3°C (760 Torr) (calculated) 79 density 0.863 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 8.173 (25°C) (calculated) 79 Myristyl Laurate melting point 40-40.4°C 78 Myristyl Stearate molecular weight 480.85 79 form waxy solid at room temperature 37 Octyldodecyl Behenate molecular weight 621.12 79 boiling point 603.0°C (760 Torr) (calculated) 79 density 0.855 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 19.990 (25°C) (calculated) 79 Octyldedecyl Erucate molecular weight 619.10 79 boiling point 646.0°C (760 Torr) (calculated) 79 density 0.860 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 19.581 (25°C) (calculated) 79 Octyldodecyl Ethylhexanoate molecular weight 424.74 79 boiling point 449.2°C (760 Torr) (calculated) 79 density 0.858 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 12.701 (25°C) (calculated) 79 Octyldodecyl Myristate characteristics colorless odorless liquid 34 saponification value 105 - 111 34 Octyldodecyl Neopentanoate molecular weight 382.66 79 boiling point 405.6°C (760 Torr) (calculated) 79 density 0.859 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 11.074 (25°C) (calculated) 79 Octyldodecyl Oleate molecular weight 562.99 79 boiling point 608.2°C (760 Torr) (calculated) 79 density 0.861 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 17.543 (25°C) (calculated) 79 Octyldodecyl Stearate molecular weight 565.01 79 boiling point 563.8°C (760 Torr) (calculated) 79 density 0.856 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 17.952 (25°C) (calculated) 79 Oleyl Arachidate molecular weight 562.99 79 melting point 39.5-40°C 78 boiling point 617.5°C (760 Torr) (calculated) 79 density 0.862 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 17.699 (25°C) (calculated) 79 Oleyl Erucate molecular weight 589.03 79 boiling point 637.7°C (760 Torr) (calculated) 79 density 0.866 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 18.308 (25°C) (calculated) 79 Oleyl Linoleate molecular weight 530.91 79 boiling point 595.5°C (760 Torr) (calculated) 79 density 0.874 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 15.867 (25°C) (calculated) 79 Oleyl Oleate molecular weight 532.92 79 melting point -4.0 to -3.5°C 78 -1.5°C 2 boiling point 596.5°C (760 Torr) (calculated) 79 density 0.868 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 16.270 (25°C) (calculated) 79 Oleyl Stearate molecular weight 534.94 79 melting point 34.0-34.5°C 78 boiling point 595.8°C (760 Torr) (calculated) 79 density 0.862 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 16.680 (25°C) (calculated) 79

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Table 7. Chemical and physical properties Property Description Reference Propylheptyl Caprylate molecular weight 284.48 79 purity >80% 25 melting point -38.9°C 25 boiling point 319.0°C (101.3 kPa) 25 waer solubility <0.01 mg/l (20°C) 25 density 0.863 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 7.963 (25°C) (calculated) 79 Stearyl Erucate molecular weight 591.05 79 boiling point 627.8°C (760 Torr) (calculated) 79 density 0.861 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 18.718 (25°C) (calculated) 79 Stearyl Ethylhexanoate form liquid 22 molecular weight 396.69 79 boiling point 431.9°C (760 Torr) (calculated) 79 density 0.859 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 11.838 (25°C) (calculated) 79 Stearyl Linoleate molecular weight 532.92 79 boiling point 590.8°C (760 Torr) (calculated) 79 density 0.868 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 16.276 (25°C) (calculated) 79 Tetradecyloctadecyl Hexyldecanoate molecular weight 705.27 79 boiling point 653.7°C (760 Torr) (calculated) 79 density 0.854 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 22.891 (25°C) (calculated) 79 Tridecyl Behenate molecular weight 522.93 79 boiling point 538.8°C (760 Torr) (calculated) 79 density 0.857 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 16.579 (25°C) (calculated) 79 Tridecyl Erucate molecular weight 520.91 79 boiling point 573.1°C (760 Torr) (calculated) 79 density 0.863 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 16.170 (25°C) (calculated) 79 Tridecyl Laurate molecular weight 382.66 79 boiling point 426.6°C (760 Torr) (calculated) 79 density 0.860 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 11.485 (25°C) (calculated) 79 Tridecyl Isononanoate molecular weight 340.58 40 log P 8.02 (calculated) 40 Tridecyl Stearate molecular weight 466.82 79 boiling point 496.0°C (760 Torr) (calculated) 79 density 0.858 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 14.541 (25°C) (calculated) 79

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Table 8. Frequency and concentration of use according to duration and type of exposure # of Uses5 Max Conc of Use (%)6,7 # of Uses5 Max Conc of Use (%)6,7 # of Uses5 Max Conc of Use (%)6,7 Arachidyl Behenate Arachidyl Propionate Behenyl Beeswax Totals* 20 0.3-4 48 0.0003-15 1 0.4 Duration of Use Leave-On 20 0.3-4 39 0.002-15 1 0.4 Rinse-Off NR NR 9 0.0003-15 NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 5 3 3 3-14 1 0.4 Incidental Ingestion 2 3-4 6 8-15 NR NR Incidental Inhalation-Spray NR NR NR 14a NR NR 0.0002 (spray) Incidental Inhalation-Powder NR NR NR 14 NR NR Dermal Contact 18 0.3-3 37 0.002-15 NR 0.4 Deodorant (underarm) NR NR NR 15 (not a spray) NR NR Hair - Non-Coloring NR NR 5 0.0003-0.003 NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR 0.05-0.09 NR NR Mucous Membrane 2 3-4 7 8-15 NR NR Baby Products NR NR NR NR NR NR Behenyl Behenate Behenyl Erucate Behenyl Olivate Totals* 5 0.4-5 9 0.5 NR 0.5 Duration of Use Leave-On 5 0.4-5 9 0.5 NR 0.5 Rinse Off NR NR NR NR NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 2 0.6-5 NR NR NR NR Incidental Ingestion NR 4 9 0.5 NR NR Incidental Inhalation-Spray NR NR NR NR NR NR Incidental Inhalation-Powder NR NR NR NR NR NR Dermal Contact 5 0.4-2 NR NR NR 0.5 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR 4 9 0.5 NR NR Baby Products NR NR NR NR NR NR Butyl Avocadate Butyl Myristate Butyl Stearate Totals* 10 1 4 5 10 0.0008-12 Duration of Use Leave-On 6 1 4 5 10 0.002-12 Rinse-Off 4 NR NR NR NR 0.0008-2 Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area NR NR NR NR 5 0.4-9 Incidental Ingestion NR NR NR NR 2 0.1-12 Incidental Inhalation-Spray 1a NR NR NR NR 0.6a-5 Incidental Inhalation-Powder NR NR NR NR NR 0.5-2 Dermal Contact 6 1 4 NR 8 0.0008-9 Deodorant (underarm) NR NR NR NR NR 0.6 (not a spray) Hair - Non-Coloring 4 NR NR 5 NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR NR NR NR 2 0.1-12 Baby Products NR NR NR NR NR NR C12-13 Alkyl Ethylhexanoate C12-15 Alkyl Ethylhexanoate C20-40 Alkyl Stearate Totals* 8 13-27 45 1-22 11 NR Duration of Use Leave-On 8 13-27 45 1-22 11 NR Rinse-Off NR NR NR NR NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 4 13-27 2 2-5 NR NR Incidental Ingestion 2 17 NR NR 8 NR Incidental Inhalation-Spray NR NR 1 NR NR NR Incidental Inhalation-Powder NR NR 1 12 NR NR Dermal Contact 6 13-27 45 1-22 NR NR Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR 3 NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane 2 17 NR NR 8 NR Baby Products NR NR NR NR NR NR 65

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Table 8. Frequency and concentration of use according to duration and type of exposure # of Uses5 Max Conc of Use (%)6,7 # of Uses5 Max Conc of Use (%)6,7 # of Uses5 Max Conc of Use (%)6,7 Caprylyl Caprylate Caprylyl Eicosenoate Cetearyl Behenate Totals 11 NR 2 0.3 3 7-15 Duration of Use Leave-On 11 NR 2 0.3 3 7-15 Rinse Off NR NR NR NR NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 1 NR NR NR 1 NR Incidental Ingestion NR NR NR NR NR 7 Incidental Inhalation-Spray NR NR NR NR NR NR Incidental Inhalation-Powder NR NR NR 0.3 NR NR Dermal Contact 11 NR 2 0.3 3 14-15 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR NR NR NR NR 7 Baby Products NR NR NR NR NR NR Cetearyl Candelillate Cetearyl Ethylhexanoate Cetearyl Isononanoate Totals* 2 6 382 0.00009-46 162 0.2-40 Duration of Use Leave-On 2 6 361 0.00009-46 140 0.2-40 Rinse-Off NR NR 18 0.6-2 22 1-4 Diluted for (Bath) Use NR NR 3 NR NR NR Exposure Type Eye Area NR NR 60 0.3-26 18 NR Incidental Ingestion 1 6 2 0.2-5 1 5 Incidental Inhalation-Spray 1a NR 17a 3 8a 40 (spray) 0.2 (aerosol) 6 (pump spray) 0.00009-5 (pump spray) Incidental Inhalation-Powder NR NR 22 1-8 1 NR Dermal Contact 1 NR 354 0.3-35 158 0.2-40 Deodorant (underarm) NR NR 2b 0.6 (not spray) NR NR 0.6 (aerosol) Hair - Non-Coloring NR NR 25 0.00009-2 3 NR Hair-Coloring NR NR NR 0.6 NR NR Nail NR NR 1 46 1 NR Mucous Membrane 1 6 5 0.2-5 3 5 Baby Products NR NR NR NR NR NR Cetearyl Olivate Cetearyl Stearate Cetyl Babassuate Totals* 146 0.3-3 3 NR 2 NR Duration of Use Leave-On 114 0.3-3 3 NR 2 NR Rinse-Off 32 0.4-2 NR NR NR NR Diluted for (Bath) Use NR 2a NR NR NR NR Exposure Type Eye Area 14 1-3 NR NR NR NR Incidental Ingestion NR NR NR NR NR NR Incidental Inhalation-Spray 2a 2a NR NR NR NR Incidental Inhalation-Powder 1 NR NR NR NR NR Dermal Contact 141 0.3-3 3 NR 2 NR Deodorant (underarm) 1b NR NR NR NR NR Hair - Non-Coloring 3 2 NR NR NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane 3 NR NR NR NR NR Baby Products 1 NR NR NR NR NR

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Table 8. Frequency and concentration of use according to duration and type of exposure # of Uses5 Max Conc of Use (%)6,7 # of Uses5 Max Conc of Use (%)6,7 # of Uses5 Max Conc of Use (%)6,7 Cetyl Caprate Cetyl Caprylate Cetyl Esters Totals* NR 0.5 14 2-4 452 0.7 - 30 Duration of Use Leave-On NR 0.5 12 2-4 228 0.8-30 Rinse-Off NR NR 2 NR 224 0.7-5 Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area NR NR 1 NR 28 3-4 Incidental Ingestion NR 0.5 NR NR 8 12-30 Incidental Inhalation-Spray NR NR NR NR 5a NR Incidental Inhalation-Powder NR NR 1 NR 1 NR Dermal Contact NR NR 12 2-4 170 0.8-5 Deodorant (underarm) NR NR NR NR 1b NR Hair - Non-Coloring NR NR NR NR 269 0.7-5 Hair-Coloring NR NR NR NR 5 NR Nail NR NR NR NR NR NR Mucous Membrane NR 0.5 NR NR 11 NR Baby Products NR NR 1 NR 1 NR Cetyl Ethylhexanoate Cetyl Laurate Cetyl Myristate Totals* 262 0.5-78 1 NR 4 NR Duration of Use Leave-On 184 0.4-52 1 NR 4 NR Rinse-Off 78 0.5-78 NR NR NR NR Diluted for (Bath) Use NR 20 NR NR NR NR Exposure Type Eye Area 38 4-78 NR NR 1 NR Incidental Ingestion 15 10-52 NR NR NR NR Incidental Inhalation-Spray 8a 3a-8 NR NR NR NR 2 (aerosol) 2 (pump spray) Incidental Inhalation-Powder 4 1-8 NR NR NR NR Dermal Contact 187 1-78 1 NR 4 NR Deodorant (underarm) NR 1 (aerosol) NR NR NR NR Hair - Non-Coloring 59 0.5-14 NR NR NR NR Hair-Coloring 1 1-10 NR NR NR NR Nail NR 0.4-19 NR NR NR NR Mucous Membrane 17 10-52 NR NR NR NR Baby Products NR NR NR NR NR Cetyl Palmitate Cetyl Ricinoleate Cetyl Stearate Totals* 474 0.002-11 130 0.3-16 5 1-16 Duration of Use Leave-On 431 0.002-11 121 0.4-16 5 16 Rinse-Off 43 0.006-5 9 0.3 NR 1 Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 47 3-11 12 3-5 2 NR Incidental Ingestion 22 2-7 32 2-16 NR NR Incidental Inhalation-Spray 16a 0.4a-6 1a NR NR NR 8 (pump spray) Incidental Inhalation-Powder NR 0.8 4 NR NR NR Dermal Contact 442 0.002-11 89 0.3-6 5 NR Deodorant (underarm) 2b NR NR NR NR NR Hair - Non-Coloring 10 2 NR NR NR 1-16 Hair-Coloring NR 0.8 NR NR NR NR Nail 2 2-7 NR NR NR NR Mucous Membrane 26 0.006-7 32 2-16 NR NR Baby Products NR NR NR NR NR NR

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Table 8. Frequency and concentration of use according to duration and type of exposure # of Uses5 Max Conc of Use (%)6,7 # of Uses5 Max Conc of Use (%)6,7 # of Uses5 Max Conc of Use (%)6,7 Cetyl Tallowate Coco-Caprylate Coco-Caprylate/Caprate Totals 1 NR 5 NR 232 0.5-62 Duration of Use Leave-On 1 NR 5 NR 204 0.5-35 Rinse Off NR NR NR NR 22 1-62 Diluted for (Bath) Use NR NR NR NR 6 NR Exposure Type Eye Area NR NR 1 NR 26 0.7-35 Incidental Ingestion NR NR NR NR 2 0.5-9 Incidental Inhalation-Spray NR NR NR NR 15a 2-6a Incidental Inhalation-Powder NR NR NR NR 1 4-16 Dermal Contact 1 NR NR NR 229 0.5-62 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR 1 30 Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR NR NR NR 9 0.5-9 Baby Products NR NR NR NR NR NR Decyl Cocoate Decyl Oleate Decyl Olivate Totals 5 NR 200 0.5-94 1 NR Duration of Use Leave-On 3 NR 185 0.5-94 1 NR Rinse Off 2 NR 15 2-20 NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area NR NR 6 20 NR NR Incidental Ingestion NR NR NR NR NR NR Incidental Inhalation-Spray NR NR 1 2 (pump spray) NR NR Incidental Inhalation-Powder NR NR NR NR NR NR Dermal Contact 5 NR 189 0.5-20 1 NR Deodorant (underarm) NR NR 1b NR NR NR Hair - Non-Coloring NR NR 10 2-94 NR NR Hair-Coloring NR NR NR 2 NR NR Nail NR NR 1 NR NR NR Mucous Membrane NR NR NR NR NR NR Baby Products NR NR NR NR NR NR Ethylhexyl Cocoate Ethylhexyl Ethylhexanoate Ethylhexyl Hydroxystearate Totals* 89 0.0006-41 20 0.5-55 253 0.09-18 Duration of Use Leave-On 77 0.0006-41 20 1-55 228 0.1-18 Rinse-Off 12 5-9 NR 0.5 25 0.09-3 Diluted for (Bath) Use NR 6 NR NR NR 3 Exposure Type Eye Area 10 12 1 1 16 2-8 Incidental Ingestion 4 8 NR 9 79 2-18 Incidental Inhalation-Spray 11a NR NR 4 (pump spray) 3a NR Incidental Inhalation-Powder NR NR NR NR 1 NR Dermal Contact 80 2-41 20 0.5-55 150 0.1-9 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring 2 NR NR NR 4 0.09-2 Hair-Coloring NR NR NR NR NR NR Nail 3 0.0006 NR NR NR NR Mucous Membrane 5 8 NR 9 91 0.2-18 Baby Products NR NR NR NR NR NR Ethylhexyl Isononanaote Ethylhexyl Isopalmitate Ethylhexyl Isostearate Totals* 137 0.02-75 6 NR 6 27-40 Duration of Use Leave-On 134 0.02-75 6 NR 6 27-40 Rinse-Off 3 0.3-20 NR NR NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 6 0.8-20 1 NR 6 27-40 Incidental Ingestion 1 2 NR NR NR NR Incidental Inhalation-Spray 4 0.02-0.1a; 2 1a NR NR NR 4 (pump spray) Incidental Inhalation-Powder 2 NR NR NR NR NR Dermal Contact 131 0.02-75 6 NR 1 27-40 Deodorant (underarm) NR 3 (not spray) NR NR NR NR Hair - Non-Coloring 5 8 NR NR NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane 2 2 NR NR NR NR Baby Products NR NR NR NR NR NR 68

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Table 8. Frequency and concentration of use according to duration and type of exposure # of Uses5 Max Conc of Use (%)6,7 # of Uses5 Max Conc of Use (%)6,7 # of Uses5 Max Conc of Use (%)6,7 Ethylhexyl Laurate Ethylhexyl Myristate Ethylhexyl Olivate Totals* 1 NR 2 NR 2 NR Duration of Use Leave-On 1 NR 1 NR 2 NR Rinse-Off NR NR 1 NR NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area NR NR NR NR 1 NR Incidental Ingestion NR NR NR NR NR NR Incidental Inhalation-Spray NR NR NR NR NR NR Incidental Inhalation-Powder NR NR NR NR NR NR Dermal Contact 1 NR 2 NR 2 NR Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR NR NR NR NR NR Baby Products NR NR NR NR NR NR Ethylhexyl Palmitate Ethylhexyl Pelargonate Ethylhexyl Stearate Totals* 1298 0.0003-78 3 2-4 318 0.0004-38 Duration of Use Leave-On 1246 0.0003-78 2 2 286 0.0004-38 Rinse-Off 50 0.05-50 1 3-4 27 0.1-29 Diluted for (Bath) Use 2 10 NR NR 5 NR Exposure Type Eye Area 281 0.01-50 NR NR 39 0.003-38 Incidental Ingestion 210 NR NR NR 6 19-28 Incidental Inhalation-Spray 51a 3-16 NR NR 16a 2-10a 4-45 (aerosol) 0.4 (pump spray) Incidental Inhalation-Powder 67 0.3-10 NR NR 9 6 Dermal Contact 1264 0.003-78 3 2 303 0.0004-38 Deodorant (underarm) 6 1 (aerosol) NR NR NR NR Hair - Non-Coloring 18 2-4 NR NR 9 5 Hair-Coloring NR NR NR 3-4 NR 29 Nail 15 5-50 NR NR NR NR Mucous Membrane 216 1-10 NR NR 15 5-28 Baby Products 2 NR NR NR NR NR Heptyl Undecylenate Heptylundecyl Hydroxystearate Hexyl Isostearate Totals 3 0.01-26 10 20 NR 0.008-0.04 Duration of Use Leave-On 3 0.01-26 10 20 NR 0.008-0.04 Rinse Off NR 0.01-0.1 NR NR NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 3 26 8 NR NR NR Incidental Ingestion NR NR 2 20 NR NR Incidental Inhalation-Spray NR 0.01 (pump spray) NR NR NR NR Incidental Inhalation-Powder NR NR NR NR NR NR Dermal Contact 3 10-26 8 NR NR 0.008 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR 0.01-0.1 NR NR NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR 0.04 Mucous Membrane NR NR 2 20 NR NR Baby Products NR NR NR NR NR NR

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Table 8. Frequency and concentration of use according to duration and type of exposure # of Uses5 Max Conc of Use (%)6,7 # of Uses5 Max Conc of Use (%)6,7 # of Uses5 Max Conc of Use (%)6,7 Hexyl Laurate Hexyldecyl Isostearate Hexyldecyl Laurate Totals* 182 0.07-3 NR 0.2-2 39 1-2 Duration of Use Leave-On 179 0.07-3 NR 2 33 2 Rinse-Off 3 2 NR 0.2-7 6 2 Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 16 0.3-3 NR NR 2 NR Incidental Ingestion 15 0.1-2 NR NR NR NR Incidental Inhalation-Spray 12a 0.07-0.1 NR NR NR NR Incidental Inhalation-Powder 1 2 NR NR NR NR Dermal Contact 177 0.07-3 NR 0.2-2 36 1-2 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring 2 2-3 NR 0.7-2 5 2 Hair-Coloring NR NR NR NR NR NR Nail 1 2 NR NR NR NR Mucous Membrane 15 0.1-2 NR NR NR NR Baby Products 3 NR NR NR NR NR Hexyldecyl Stearate Hydrogenated Ethylhexyl Olivate Hydroxyoctacosanyl Hydroxystearate Totals* 32 0.5-13 7 0.05-16 5 NR Duration of Use Leave-On 23 0.5-13 6 4-16 5 NR Rinse-Off 9 3 1 0.05 NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 2 3 2 4 1 NR Incidental Ingestion NR 0.9 NR NR NR NR Incidental Inhalation-Spray NR NR NR 16 (pump spray) NR NR Incidental Inhalation-Powder NR NR NR NR NR NR Dermal Contact 32 0.5-13 6 4-7 5 NR Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR NR 1 0.05-16 NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR NR NR NR NR NR Baby Products NR NR NR NR NR NR Isoamyl Laurate Isocetyl Ethylhexanoate Isocetyl Myristate Totals NR 1-2 8 NR 10 0.4-37 Duration of Use Leave-On NR 1 8 NR 9 0.4-37 Rinse Off NR 2 NR NR 1 NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area NR NR 1 NR 3 NR Incidental Ingestion NR NR 1 NR NR NR Incidental Inhalation-Spray NR NR NR NR NR NR Incidental Inhalation-Powder NR NR NR NR 1 0.4-2 Dermal Contact NR 1-2 7 NR 10 0.4-37 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR NR 1 NR NR NR Baby Products NR NR NR NR NR NR Isocetyl Palmitate Isocetyl Stearate Isodecyl Cocoate Totals 5 NR 202 0.1-34 NR 2 Duration of Use Leave-On 5 NR 189 0.1-34 NR 2 Rinse Off NR NR 13 0.6-5 NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area NR NR 2 0.1-16 NR NR Incidental Ingestion NR NR 14 0.3-24 NR NR Incidental Inhalation-Spray NR NR 3a 0.6a NR NR 34 (pump spray) Incidental Inhalation-Powder NR NR 4 NR NR NR Dermal Contact 5 NR 188 0.1-34 NR 2 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR NR 8 0.5-1 NR NR Hair-Coloring NR NR NR 0.6 NR NR Nail NR NR NR NR NR NR Mucous Membrane NR NR 15 0.3-24 NR NR Baby Products NR NR NR NR NR NR 70

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Table 8. Frequency and concentration of use according to duration and type of exposure # of Uses5 Max Conc of Use (%)6,7 # of Uses5 Max Conc of Use (%)6,7 # of Uses5 Max Conc of Use (%)6,7 Isodecyl Isononanoate Isodecyl Laurate Isodecyl Myristate Totals* 36 1-44 4 NR 1 NR Duration of Use Leave-On 33 1-44 2 NR 1 NR Rinse-Off 3 10 2 NR NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 8 1-40 2 NR 1 NR Incidental Ingestion 4 40-44 NR NR NR NR Incidental Inhalation-Spray 2a NR NR NR NR NR Incidental Inhalation-Powder NR NR NR NR NR NR Dermal Contact 32 1-40 4 NR 1 NR Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane 4 40-44 NR NR NR NR Baby Products NR NR NR NR NR NR Isodecyl Neopentanoate Isodecyl Oleate Isohexyl Caprate Totals* 126 0.05-17 15 0.07-4 3 NR Duration of Use Leave-On 121 0.05-17 14 0.07-4 3 NR Rinse-Off 5 0.1-2 1 2-3 NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 25 1-17 NR 2 NR NR Incidental Ingestion 8 0.6-5 NR 0.07 NR NR Incidental Inhalation-Spray 7a 3 3 4 (aerosol) NR NR 0.5 (aerosol) 2 (pump spray) 0.3 (pump spray) Incidental Inhalation-Powder 4 2 NR NR NR NR Dermal Contact 116 0.05-17 4 2-3 3 NR Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring 1 0.3-2 10 2-4 NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR 1 NR NR NR Mucous Membrane 8 0.6-5 NR 0.07 NR NR Baby Products NR 3 NR NR NR NR Isononyl Isononanoate Isopropyl Hydroxystearate Isopropyl Iostearate Totals* 611 0.07-53 NR 8 225 0.5-19 Duration of Use Leave-On 588 0.07-53 NR 8 212 0.5-19 Rinse-Off 23 0.3-25 NR NR 13 0.7-6 Diluted for (Bath) Use NR 15 NR NR NR NR Exposure Type Eye Area 80 0.8-53 NR 8 59 0.8-10 Incidental Ingestion 47 5-47 NR NR 18 15-17 Incidental Inhalation-Spray 32a 0.1-6a; 26-45 NR NR 7a 0.6 (pump spray) 0.4 (pump spray) Incidental Inhalation-Powder 28 4-9 NR NR 16 2-19 Dermal Contact 559 0.07-53 NR 8 203 0.5-19 Deodorant (underarm) 1b 7 (not spray) NR NR NR NR 7 (aerosol) Hair - Non-Coloring 3 0.4-1 NR NR 3 0.5-0.8 Hair-Coloring NR NR NR NR NR NR Nail 2 6 NR NR NR NR Mucous Membrane 48 5-47 NR NR 19 15-17 Baby Products NR 3 NR NR 2 NR

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Table 8. Frequency and concentration of use according to duration and type of exposure # of Uses5 Max Conc of Use (%)6,7 # of Uses5 Max Conc of Use (%)6,7 # of Uses5 Max Conc of Use (%)6,7 Isopropyl Jojobate Isopropyl Linoleate Isopropyl Myristate Totals* 22 0.3-6 NR 0.1 1149 0.000005-78 Duration of Use Leave-On 22 0.3-6 NR 0.1 932 0.0002-78 Rinse-Off NR NR NR 0.1 202 0.000005-67 Diluted for (Bath) Use NR NR NR NR 15 1-22 Exposure Type Eye Area 2 0.7 NR NR 130 0.9-31 Incidental Ingestion 3 NR NR NR 53 2-18 Incidental Inhalation-Spray 1a NR NR NR 72a 0.6-36a 0.02-77 (aerosol) Incidental Inhalation-Powder NR NR NR 0.1 24 0.7-3 Dermal Contact 19 0.7-6 NR 0.1 923 0.0003-60 Deodorant (underarm) NR NR NR NR 20b 0.0003-23 (not spray) 0.03-23 (aerosol) 8 (pump spray) Hair - Non-Coloring NR NR NR 0.1 143 0.000005-78 Hair-Coloring NR NR NR NR 21 30-68 Nail NR NR NR NR 9 0.05-38 Mucous Membrane 3 NR NR NR 111 1-22 Baby Products NR NR NR NR 6 17 Isopropyl Palmitate Isopropyl Ricinoleate Isopropyl Stearate Totals 999 0.0001-76 NR 2 10 0.9-16 Duration of Use Leave-On 888 0.0001-76 NR 2 9 1-16 Rinse Off 85 0.0003-31 NR NR 1 0.9-9 Diluted for (Bath) Use 26 0.001-60 NR NR NR 7 Exposure Type Eye Area 72 0.1-34 NR NR 1 2 Incidental Ingestion 104 1-34 NR 2 NR 16 Incidental Inhalation-Spray 47a 0.4-5a; 2-76 NR NR NR NR 0.8 (aerosol) 3-20 (pump spray) Incidental Inhalation-Powder 33 3-18 NR NR NR NR Dermal Contact 829 0.0001-76 NR NR 10 1-9 Deodorant (underarm) 15 0.5-17 (not spray) NR NR 1b NR 3-5 (aerosol) Hair - Non-Coloring 33 0.0003-20 NR NR NR NR Hair-Coloring NR 44 NR NR NR NR Nail 14 0.5-12 NR NR NR 0.9 Mucous Membrane 139 0.05-34 NR 2 NR 16 Baby Products 4 2-11 NR NR NR NR Isostearyl Avocadate Isostearyl Behenate Isostearyl Hydroxystearate Totals 1 NR 7 4 21 0.01-3 Duration of Use Leave-On 1 NR 7 4 21 0.01-3 Rinse Off NR NR NR NR NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area NR NR NR NR 7 3 Incidental Ingestion NR NR NR NR NR NR Incidental Inhalation-Spray NR NR NR NR NR NR Incidental Inhalation-Powder NR NR NR NR 3 0.01 Dermal Contact 1 NR 7 4 14 0.01-3 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR NR NR NR 7 NR Baby Products NR NR NR NR NR NR

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Table 8. Frequency and concentration of use according to duration and type of exposure # of Uses5 Max Conc of Use (%)6,7 # of Uses5 Max Conc of Use (%)6,7 # of Uses5 Max Conc of Use (%)6,7 Isostearyl Isononanoate Isostearyl Isostearate Isostearyl Laurate Totals* 4 NR 194 1-31 NR 0.4 Duration of Use Leave-On 3 NR 181 1-31 NR NR Rinse-Off 1 NR 12 NR NR 0.4 Diluted for (Bath) Use NR NR 1 NR NR NR Exposure Type Eye Area NR NR 3 4 NR NR Incidental Ingestion NR NR 114 4-31 NR NR Incidental Inhalation-Spray NR NR 1 NR NR NR Incidental Inhalation-Powder NR NR NR NR NR NR Dermal Contact NR NR 75 1-30 NR 0.4 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR NR NR Hair-Coloring NR NR NR NR NR NR Nail 9 NR NR NR NR NR Mucous Membrane NR NR 115 4-31 NR NR Baby Products NR NR NR NR NR NR Isostearyl Linoleate Isostearyl Myristate Isostearyl Neopentanoate Totals* 2 2-3 1 2 225 0.5-46 Duration of Use Leave-On 2 2-3 1 2 210 0.5-46 Rinse-Off NR NR NR NR 15 5-16 Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area NR NR NR NR 78 3-30 Incidental Ingestion NR 2 NR NR 8 4-19 Incidental Inhalation-Spray NR NR NR NR 4a 0.5 (pump spray) Incidental Inhalation-Powder 1 NR NR NR 34 1-16 Dermal Contact 2 2-3 1 2 211 0.5-46 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR 13 16 Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR 1 NR Mucous Membrane NR 2 NR NR 8 4-19 Baby Products NR NR NR NR NR NR Isostearyl Palmitate Isotridecyl Isononanoate Isotridecyl Stearate Totals* 48 0.2-17 77 1-21 1 NR Duration of Use Leave-On 41 0.2-17 77 1-21 1 NR Rinse-Off 7 0.5-8 NR 3-4 NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 7 0.2-5 5 2-21 1 NR Incidental Ingestion 3 5-8 17 2 NR NR Incidental Inhalation-Spray 3a NR 3a NR NR NR Incidental Inhalation-Powder 8 1-16 6 2 NR NR Dermal Contact 39 0.2-17 60 1-21 1 NR Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring 6 NR NR 3 NR NR Hair-Coloring NR NR NR NR NR NR Nail NR 1 NR NR NR NR Mucous Membrane 3 0.5-8 17 2 NR NR Baby Products NR NR NR NR NR NR Lauryl Laurate Lauryl Palmitate Myristyl Laurate Totals 30 0.1-16 2 NR 10 0.1-2 Duration of Use Leave-On 30 0.1-16 1 NR 9 0.2-2 Rinse Off NR NR 1 NR 1 0.1-0.7 Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 2 0.8-16 NR NR 1 0.4-2 Incidental Ingestion 1 NR NR NR 1 2 Incidental Inhalation-Spray 3 NR NR NR NR 0.2a Incidental Inhalation-Powder NR 0.1 NR NR NR NR Dermal Contact 27 0.1-16 1 NR 9 0.1-2 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring 1 NR 1 NR NR 0.4-0.5 Hair-Coloring NR NR NR NR NR NR Nail 1 NR NR NR NR NR Mucous Membrane 1 NR NR NR 1 2 Baby Products NR NR NR NR NR NR

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Table 8. Frequency and concentration of use according to duration and type of exposure # of Uses5 Max Conc of Use (%)6,7 # of Uses5 Max Conc of Use (%)6,7 # of Uses5 Max Conc of Use (%)6,7 Myristyl Myristate Myristyl Neopentanoate Octyldodecyl Erucate Totals* 402 0.5-17 NR 2 1 0.01-10 Duration of Use Leave-On 360 0.5-17 NR 2 1 0.01-10 Rinse-Off 38 0.5-4 NR NR NR 0.01-0.1 Diluted for (Bath) Use 4 1-2 NR NR NR NR Exposure Type Eye Area 58 1-12 NR 2 NR 0.01-0.2 Incidental Ingestion 30 1-12 NR NR NR 10 Incidental Inhalation-Spray 15a 0.5-0.8a; 2-17 NR NR NR NR Incidental Inhalation-Powder 6 2-5 NR NR NR 0.1 Dermal Contact 354 0.5-17 NR 2 1 0.1-1 Deodorant (underarm) 14b 2 (not a spray) NR NR NR NR Hair - Non-Coloring 17 0.5-8 NR NR NR NR Hair-Coloring NR 1 NR NR NR NR Nail 1 1-7 NR NR NR 0.01 Mucous Membrane 35 1-12 NR NR NR 10 Baby Products 4 2-3 NR NR NR NR Octyldodecyl Hydroxstearate Octyldodecyl Isostearate Octyldodecyl Myristate Totals* 1 NR 1 2 142 0.05-32 Duration of Use Leave-On 1 NR 1 2 130 0.05-32 Rinse-Off NR NR NR NR 12 0.4-3 Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 1 NR NR 2 16 0.05-2 Incidental Ingestion NR NR 1 NR 19 0.08-21 Incidental Inhalation-Spray NR NR NR NR 11a NR Incidental Inhalation-Powder NR NR NR NR 3 NR Dermal Contact 1 NR NR 2 138 0.05-32 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR 2 3 Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR NR 1 NR 19 0.08-21 Baby Products NR NR NR NR 2 NR Octyldodecyl Neopentanoate Octyldodecyl Octyldodecanoate Octyldodecyl Olivate Totals* 107 0.5-20 1 4 11 2 Duration of Use Leave-On 105 0.5-20 1 4 11 2 Rinse-Off 2 3 NR NR NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 20 1-9 NR NR 2 NR Incidental Ingestion 16 0.7-12 NR NR NR NR Incidental Inhalation-Spray 7a 7a NR NR NR NR 20 (pump spray) Incidental Inhalation-Powder 2 2-4 NR NR NR NR Dermal Contact 89 0.8-20 1 4 11 2 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring 9 0.5 NR NR NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane 16 0.7-12 NR NR NR NR Baby Products NR NR NR NR NR NR Octyldodecyl Ricinoleate Octyldodecyl Stearate Oleyl Erucate Totals* 11 0.9-3 29 3-19 44 1-12 Duration of Use Leave-On 6 0.9-3 29 3-19 40 1-12 Rinse-Off 5 NR NR NR 4 NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area NR NR 21 4-19 1 12 Incidental Ingestion NR 0.9-3 2 9 16 NR Incidental Inhalation-Spray NR NR NR NR 8a NR Incidental Inhalation-Powder NR NR 1 NR NR 11 Dermal Contact 3 3 27 3-19 27 1-12 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring 8 NR NR NR 1 NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR 0.9-3 2 9 17 NR Baby Products NR NR NR NR NR NR 74

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Table 8. Frequency and concentration of use according to duration and type of exposure # of Uses5 Max Conc of Use (%)6,7 # of Uses5 Max Conc of Use (%)6,7 # of Uses5 Max Conc of Use (%)6,7 Oleyl Linoleate Oleyl Oleate Propylheptyl Caprylate Totals NR 10-11 11 0.4-9 24 1-13 Duration of Use Leave-On NR 10-11 10 0.4-9 23 2-13 Rinse Off NR 10 1 1 1 1 Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area NR NR 3 NR NR NR Incidental Ingestion NR 10 4 9 9 13 Incidental Inhalation-Spray NR NR NR NR 2a 5 Incidental Inhalation-Powder NR NR 3 NR NR NR Dermal Contact NR 10 7 0.4-3 14 2-6 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR 1 1 Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR 11 4 9 9 13 Baby Products NR NR NR NR NR NR Stearyl Beeswax Stearyl Caprylate Stearyl Ethylhexanoate Totals 10 0.4 28 0.3-10 8 0.2-10 Duration of Use Leave-On 9 0.4 27 0.3-10 8 0.2-10 Rinse Off 1 NR 1 NR NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area NR 0.4 5 0.3-1 NR NR Incidental Ingestion NR NR 2 0.5 NR 0.2 Incidental Inhalation-Spray NR NR NR 10a NR 10a Incidental Inhalation-Powder NR NR NR NR NR NR Dermal Contact 10 0.4 26 0.3-10 5 7-10 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR NR NR 3 2 NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR 0.2 Mucous Membrane NR NR 3 0.5 1 0.2 Baby Products NR NR NR NR NR NR Stearyl Heptanoate Stearyl Olivate Stearyl Palmitate Totals 95 0.6-11 3 NR NR 0.02-0.6 Duration of Use Leave-On 91 0.6-11 1 NR NR 0.02-0.6 Rinse Off 4 2.7 2 NR NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 18 0.6-11 NR NR NR 0.02-0.6 Incidental Ingestion 11 2-11 NR NR NR NR Incidental Inhalation-Spray 1 NR NR NR NR NR Incidental Inhalation-Powder NR 2 NR NR NR NR Dermal Contact 82 0.6-11 3 NR NR NR Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring 2 2-3 NR NR NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane 14 2-11 1 NR NR NR Baby Products NR NR NR NR NR NR Stearyl Stearate Tetradecyloctadecyl Stearate Tridecyl Ethylhexanoate Totals 26 0.02-3 1 NR 4 NR Duration of Use Leave-On 24 0.02-3 1 NR 4 NR Rinse Off 2 2 NR NR NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 5 0.2 NR NR NR NR Incidental Ingestion 5 0.3-0.9 NR NR NR NR Incidental Inhalation-Spray 2 NR NR NR 1 NR Incidental Inhalation-Powder NR N NR NR 1 NR Dermal Contact 19 0.02-2 1 NR 4 NR Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring 2 3 NR NR NR NR Hair-Coloring NR 2 NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane 7 0.3-2 NR NR NR NR Baby Products NR NR NR NR NR NR

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Table 8. Frequency and concentration of use according to duration and type of exposure # of Uses5 Max Conc of Use (%)6,7 # of Uses5 Max Conc of Use (%)6,7 # of Uses5 Max Conc of Use (%)6,7 Totals Tridecyl Isononanoate Tridecyl Neopentanoate Tridecyl Stearate Duration of Use 1 NR 16 2-41 85 0.2-18 Leave-On 1 NR 15 2-41 69 0.2-16 Rinse Off NR NR 1 5 15 2-18 Diluted for (Bath) Use NR NR NR NR 1 NR Exposure Type Eye Area NR NR 10 5-41 NR 0.3 Incidental Ingestion NR NR 2 2.5 10 3-16 Incidental Inhalation-Spray NR NR NR NR 1a 2 0.4 (pump spray) Incidental Inhalation-Powder NR NR NR 5 1 NR Dermal Contact 1 NR 14 2-41 68 0.2-18 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR 7 0.4-7 Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR NR 2 2-5 11 3-16 Baby Products NR NR NR NR 1 NR

*Because each ingredient may be used in cosmetics with multiple exposure types, the sum of all exposure types may not equal the sum of total uses. aIncludes suntan products, in that it is now known whether or not the reported product is a spray. bIt is not known whether or not the product is a spray. NR – no reported uses

Table 9. Ingredients not reported to be used Arachidyl Erucate Decyltetradecyl Cetearate Isopropyl Oleate Batyl Isostearate Decyltetradecyl Ethylhexanoate Isopropyl Sorbate Batyl Stearate Ethylhexyl Adipate/Palmitate/Stearate Isopropyl Tallowate Behenyl Isostearate Ethylhexyl C10-40 Isoalkyl Acidate Isostearyl Erucate Behenyl/Isostearyl Beeswax Ethylhexyl Neopentanoate Isostearyl Ethylhexanoate Butyl Babassuate Ethylhexyl Oleate Isotridecyl Laurate Butyl Isostearate Erucyl Arachidate Isotridecyl Myristate Butyl Oleate Erucyl Erucate Lauryl Behenate Butyloctyl Beeswax Erucyl Oleate Lauryl Cocoate Butyloctyl Behenate Hexyldecyl Ethylhexanoate Lauryl Ethylhexanoate Butyloctyl Candelillate Hexyldecyl Hexyldecanoate Lauryl Isostearate Butyloctyl Cetearate Hexyldecyl Oleate Lauryl Myristate Butyloctyl Oleate Hexyldecyl Palmitate Lauryl Oleate Butyloctyl Palmitate Hexyldodecyl/Octyldecyl Hydroxystearate Lauryl Stearate C14-30 Alkyl Beeswax Hydrogenated Castor Oil Behenyl Esters Lignoceryl Erucate C18-38 Alkyl Beeswax Hydrogenated Castor Oil Cetyl Esters Myristyl Ethylhexanoate C30-50 Alkyl Beeswax Hydrogenated Castor Oil Stearyl Esters Myristyl Isostearate C20-40 Alkyl Behenate Hydrogenated Ethylhexyl Sesamate Octyldecyl Oleate C18-38 Alkyl C24-54 Acid Ester Hydrogenated Isocetyl Olivate Octyldodecyl Avocadoate C14-18 Alkyl Ethylhexanoate Hydrogenated Isopropyl Jojobate Octyldodecyl Beeswax C16-36 Alkyl Stearate Hydroxycetyl Isostearate Octyldodecyl Behenate C30-50 Alkyl Stearate Isobutyl Myristate Octyldodecyl Cocoate C40-60 Alkyl Stearate Isobutyl Palmitate Octyldodecyl Ethylhexanoate Caprylyl Butyrate Isobutyl Pelargonate Octyldodecyl Hydroxystearate Cetearyl Nonanoate Isobutyl Stearate Octyldodecyl Meadowfoamate Cetearyl Palmate Isobutyl Tallowate Octyldodecyl Neodecanoate Cetearyl Palmitate Isocetyl Behenate Octyldodecyl Oleate Cetearyl Rice Branate Isocetyl Isodecanoate Octyldodecyl Safflowerate Cetyl Behenate Isocetyl Isostearate Oleyl Arachidate Cetyl Dimethyloctanoate Isocetyl Laurate Oleyl Myristate Cetyl Isononanoate Isodecyl Ethylhexanoate Oleyl Stearate Cetyl Myristoleate Isodecyl Hydroxystearate Stearyl Behenate Cetyl Oleate Isodecyl Palmitate Stearyl Erucate Chimyl Isostearate Isodecyl Stearate Stearyl Linoleate Chimyl Stearate Isohexyl Laurate Tetradecyleicosyl Stearate C10-40 Isoalkyl Acid Octyldodecanol Esters Isohexyl Neopentanoate Tetradecyloctadecyl Behenate C4-5 Isoalkyl Cocoate Isohexyl Palmitate Tetradecyloctadecyl Hexyldecanoate C32-36 Isoalkyl Stearate Isolauryl Behenate Tetradecyloctadecyl Myristate Coco-Rapeseedate Isooctyl Caprylate/Caprate Tetradecylpropionates Decyl Castorate Isooctyl Tallate Tridecyl Behenate Decyl Isostearate Isopropyl Arachidate Tridecyl Cocoate Decyl Jojobate Isopropyl Avocadate Tridecyl Erucate Decyl Laurate Isopropyl Babassuate Tridecyl Laurate Decyl Myristate Isopropyl Behenate Tridecyl Myristate Decyl Palmitate Isopropyl Laurate

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Table 10. Examples of non-cosmetic uses Ingredient Non-Cosmetic Use Reference Behenyl Behenate used in mold releasing agents in methyl acrylamide polymer 73 Butyl Oleate indirect food additive as a plasticizer in rubber articles 21CFR177.2600 biodiesel additive; polyvinylchloride plasticizer; water-resisting agent; in hydraulic fluids 90 Ethylhexyl Ethylhexanoate used in pharmaceutical preparations for improving the spreading behavior of the oil 74 Ethylhexyl Laurate lubricant for friction and in paper industry; activity enhancer for pesticides 75 Isoamyl Laurate direct food additive as a synthetic flavoring substance and adjuvant 21CFR172.515 Isobutyl Palmitate indirect food additive used in fiber finishing or in textile fibers 21CFR177.2260; 21CFR177.2800 Isooctyl Tallate indirect food additive as a plasticizer in rubber articles 21CFR177.2600 Isopropy Laurate indirect food additive as a lubricant in the manufacture of metallic articles; use level not to exceed 21CFR178.3910 10% by wt. Isopropyl Oleate indirect food additive as a lubricant in the manufacture of metallic articles or in mineral oil 21CFR178.3910; lubricants with incidental food contact 21CFR178.3570

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17. Liu P, Cettina M, and Wong J. Effects of isopropanol-isopropyl myristate binary enhancers on in vitro transport of estradiol in human epidermis: a mechanistic evaluation. Journal of Pharmaceutical Sciences. 2009;98:(2):565- 572.

18. Caussin J, Rozema E, Gooris GS, Wiechers JW., Pavel S, and ouwstra JA. Hydrophilic and lipophilic moisturizers have similar penetration profiles but different effects on SC water distribution in vivo. Experimental Dermatology. 2009;18:(11):954-961.

19. Andersen F, Bindslev-Jensen C, Andersen KE, Hedegaard K, and Fullerton A. Comparison of the response to topical irritants in hairless guinea pigs and human volunteers. Cutaneous and Ocular Toxicology. 2005;24:(1):31-43.

CIR Panel Book Page 104 Distributed for Comment Only -- Do Not Cite or Quote

20. Guo H, Liu Z, Li J, Nie S, and Pan W. Effects of isopropyl palmitate on the skin permeation of drugs. Biological & Pharmaceutical Bulletin. 2006;29:(11):2324-2326.

21. Cornwell PA, Tubek J, van Gompel HAHP, Little CJ, and Wiechers JW. Glyceryl monocaprylate/caprate as a moderate skin penetration enhancer. International Journal of Pharmaceutics. 1998;171:(2):243-255.

22. Fujii M, Shiozawa K, Henmi T, Yamanouchi S, Suzuki H, Yamashita N, and Matsumoto M. Skin permeation of indomethacin from gel formed by fatty-acid ester and phospholipid. International Journal of Pharmaceutics. 1996;137:(1):117-124.

23. Fujii M, Hori N, Shiozawa K, Wakabayashi K, Kawahara E, and Matsumoto M. Effect of fatty acid esters on permeation of ketoprofen through hairless rat skin. International Journal of Pharmaceutics. 2000;205:(1-2):117-125.

24. MB Research Laboratories Inc. 1975. Acute oral toxicity in rats and dermal toxicity in rabbits. Unpublished data submitted by the Research Institute for Fragrance Materials. 1 pages.

25. National Industrial Chemicals Notification and Assessment Scheme (NICNAS). Full Public Report. Cetiol Sensoft. File No: STD/1264. http://www.nicnas.gov.au/publications/CAR/new/Std/stdFULLR/std1000FR/std1264FR.pdf. 2008. Date Accessed 1-5-2012.

26. European Commission. IUCLID Dataset for 2-ethylhexyl laurate, substance ID: 20292-08-4. http://esis.jrc.ec.europa.eu/doc/existing-chemicals/IUCLID/data_sheets/20292084.pdf. 2000. Date Accessed 1- 4-2012.

27. National Industrial Chemicals Notification and Assessment Scheme (NICNAS). Full public report. Dodecanoic acid, dimethyloctly ester. File no: NA/622. http://www.nicnas.gov.au/publications/CAR/new/NA/NAFULLR/NA0600FR/NA622FR.pdf. 1998. Date Accessed 1-5-2012.

28. Motoyoshi K, Toyoshima Y, Sato M, and Yoshimura M. Comparative studies on the irritancy of oils and synthetic perfumes to the skin of rabbit, guinea pig, rat, miniature swine and man. Cosmetics & Toiletries. 1979;94:(8):41- 3, 45.

29. Trattner A., Farchi Y., and David M. Cosmetics patch test: first report from Israel. Contact Dermatitis. 2002;47:(3):180- 181.

30. Kligman AM. 1975. Report on human maximization studies. Unpublished data submitted by the Research Institute for Fragrance Materials. 2 pages.

31. Pennick G, Harrison S, Jones D, and Rawlings AV. Superior effect of isostearyl isostearate on improvement in stratum corneum water permeability barrier function as examined by the plastic occlusion stress test. International Journal of Cosmetic Science. 2010;32:(4):304-312.

32. Elder RL (ed). Final report on the safety assesment of arachidyl propionate. J Am Coll Toxicol. 1990;9:(2):143-152.

33. Andersen FA (ed). Annual review of cosmetic ingredient safety assessments: 2005/2006. Int J Toxicol. 2008;27:(Suppl 1):77-142.

34. Becker LC, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Marks JG, Shank RC, Slaga TJ, Snyder PW, and Andersen FA. Final report of the amended safety assessment of myristic acid and its salts and esters as used in cosmetics. Int J Toxicol. 2010;29:(Suppl 3):162-186.

35. Elder RL (ed). Final report on the safety assessment of butyl myristate. J Am Coll Toxicol. 1990;9:(2):247-258.

36. Andersen FA (ed). Annual review of cosmetic ingredient safety assessments - 2002/2003. Int J Toxicol. 2005;24:(Suppl 1):1-102.

37. Elder RL (ed). Final report on the safety assessment of butyl stearate, cetyl stearate, isobutyl stearate, isocety stearate, isopropyl stearate, myristyl stearate, and octyl stearate. J Am Coll Toxicol. 1985;4:(5):107-146.

CIR Panel Book Page 105 Distributed for Comment Only -- Do Not Cite or Quote

38. Elder RL (ed). Final report on the safety assessment of cetearyl octanoate. J Am Coll Toxicol. 1982;1:(4):81-90.

39. Andersen FA (ed). Annual review of cosmetic ingredient safety assessments - 2004/2005. Int J Toxicol. 2006;25:(Suppl 2):1-89.

40. Johnson WJ, Heldreth BA, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG, Shank RC, Slaga TJ, Snyder PW, and Andersen FA. Final report of the Cosmetic Ingredient Review Expert Panel in the safety assessment of pelargonic acid (aka nonanoic acid) and nonanoate esters. 2010. Available from CIR, 1101 17th St, NW, Ste 412, Washington DC 20036; www.cir-safety.org.

41. Elder RL (ed). Final report on the safety assessment of octyl palmitate, cetyl palmitate, and isopropyl palmitate. J Am Coll Toxicol. 1982;1:(2):13-35.

42. Andersen FA (ed). Final Report on the Safety Assessment of Ricinus Communis (Castor) Seed Oil, Hydrogenated Castor Oil, Glyceryl Ricinoleate, Glyceryl Ricinoleate SE, Ricinoleic Acid, Potassium Ricinoleate, Sodium Ricinoleate, Zinc Ricinoleate, Cetyl Ricinoleate, Ethyl Ricinoleate, Glycol Ricinoleate, Isopropyl Ricinoleate, Methyl Ricinoleate, and Octyldodecyl Ricinoleate. Int J Toxicol. 2007;26:(Suppl 3):31-77.

43. Burnett CL, Bergfeld WF, Belsito DV, Klaassen CD, Marks JG, Shank RC, Slaga TJ, Snyder PW, and Andersen FA. Final report on the safety assessment of Cocos nucifera (coconout) oil and related ingredients. Int J Toxicol. 2011;30:(Suppl 1):55-165.

44. Andersen FA (ed). Annual review of cosmetic ingredient safety assessments - 2001/2002. Int J Toxicol. 2003;22:(Suppl 1):1-35.

45. Andersen FA (ed). Final report on the safety assessment of isopropyl isostearate. J Am Coll Toxicol. 1992;11:(1):43-49.

46. Andersen FA (ed). Annual review of cosmetic ingredient safety assessments: 2007-2010. Int J Toxicol. 2011;30:(Suppl 2):73-127.

47. Elder RL (ed). Final report on the safety assessment of isopropyl linoleate. J Am Coll Toxicol. 1992;11:(1):51-56.

48. Elder RL (ed). Final report on the safety assessment of myristyl myristate and isopropyl myristate. J Am Coll Toxicol. 1982;1:(4):55-80.

49. Elder RL (ed). Final report on the safety assessment of isosteary neopentanoate. J Am Coll Toxicol. 1985;4:(3):1-22.

50. Fiume MM, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG, Shank RC, Slaga TJ, Snyder PW, and Andersen FA. Final report on stearyl heptanoate and related stearyl alkanoates as used in cosmetics. 2010. Available from CIR, 1101 17th St, NW, Ste 412, Washington DC 20036; www.cir-safety.org.

51. Andersen FA (ed). Final report on the safety assessement of stearyl heptanoate. J Am Coll Toxicol. 1995;14:(6):498-510.

52. Johnson WJ, Bergfeld WF, Marks JG, Hill RA, Klaassen CD, Liebler DC, Marks JG, Shank RC, Slaga TJ, Snyder PW, and Andersen FA. Fi nal safety assessment of alkyl glyceryl ethers as used in cosmetics. 2011. Available from CIR, 1101 17th St, NW, Ste 412, Washington DC 20036' www.cir-safety.org.

53. Elder, RL (ed). Final report o the safety assessment of cetearyl alcohol, cetyl alcohol, isostearyl alcohol, myristyl alcohol, and behenyl alcohol. J Am Coll Toxicol. 1988;7:(3):359-413.

54. Andersen FA (ed). Final report of the addendum to the safety assessment of n-butyl alcohol as used in cosmetics. Int J Toxicol. 2008;27:(Suppl 2):53-69.

55. Johnson WJ, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG, Shank RC, Slaga TJ, Snyder PW, and Andersen FA. Final report of the Cosmetic Ingredient Review Expert Panel on the Safety Assessment of 1,2- Glycols as Used in Cosmetics. 2011. Available from CIR, 1101 17th St, NW, Ste 412, Washington DC 20036; www.cir-safety.org.

56. Heldreth BA, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG, Shank RC, Slaga TJ, Snyder PW, and Andersen FA. Final report on methyl acetate, simple acetate esters, acetic acid and salts, and related alcohols

CIR Panel Book Page 106 Distributed for Comment Only -- Do Not Cite or Quote

as used in cosmetics. 2010. Available from CIR, 1101 17th St, NW, Ste 412, Washington DC 20036; www.cir- safety.org.

57. Becker LC, Bergfeld WF, Belsito DV, Klaassen CD, Marks JG, Shank RC, Slaga TJ, Snyder PW, and Andersen FA. Final report of the Cosmetic Ingredient Review Expert Panel on Simmondsia Chinensis (Jojoba) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Wax, Hydrogenated Jojoba Oil, Hydrolyzed Jojoba Esters, Isomerized Jojoba Oil, Jojoba Esters, Simmondsia Chinensis (Jojoba) Butter, Jojoba Alcohol, and Synthetic Jojoba Oil. 2008. Available from CIR, 1101 17th St, NW, Ste 412, Washington DC 20036; www.cir-safety.org.

58. Elder RL (ed). Final report on the safety assessment of stearyl alcohol, oleyl alcohol, and octyl dodecanol. J Am Coll Toxicol. 1985;4:(5):1-29.

59. Fiume MM, Heldreth BA, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG, Shank RC, Slaga TJ, Snyder PW, and Andersen FA. Final report on dicarboxylic acids and their salts as used in cosmetics and on esters of dicarboxylic acids as used in cosmetics. 2010. Available from CIR, 1001 17th St, NW, Ste 412, Washington DCD 20036; www.cir-safety.org.

60. Burnett CL, Fiume MM, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG, Shank RC, Slaga TJ, Snyder PW, and Andersen FA. Final report on plant-derived fatty acid oils as used in cosmetics. 2011. Available from CIR, 1101 17th ST, NW, Ste 312, Washington DC 20036; www.cir-safety.org.

61. Andersen FA (ed). Amended final report on the safety assessment of hydroxstearic acid. Int J Toxicol. 1999;18:(Suppl 1):1-10.

62. Elder RL (ed). Final report on the safety assessment of isostearic acid. J Am Coll Toxicol. 1983;2:(7):61-74.

63. Elder RL (ed). Final report on the safety assessment of oleic acid, lauric acid, palmitic acid, myristic acid, and stearic acid. J Am Coll Toxicol. 1987;6:(3):321-401.

64. Elder RL (ed). Final report on the safety assessment of sorbic acid and potassium sorbate. J Am Coll Toxicol. 1988;7:(6):837-880.

65. Elder RL (ed). Final report on the safety assessment of tall oil acid. J Am Coll Toxicol. 1989;8:(4):769-776.

66. Robinson V, Bergfeld WF, Belsito DV, Klaassen CD, Marks JG, Shank RC, Slaga TJ, Snyder PW, and Andersen FA. Amended safety assessment of tall oil acid, sodium tallate, potassium tallate, and ammonium tallate. Int J Toxicol. 2009;28:(Suppl 3):352-358.

67. Bannister WJ. Normal butyl oleate. 3-10-1931. US 1930-453101:(US 1796231):Date Accessed 5-16-1930

68. Opdyke DLJ. Monographs on fragrance raw materials. Butyl oleate. Food and Cosmetics Toxicology. 1979;17:(3):249.

69. Othmer DF and Rao SA. Butyl oleate from butyl alcohol and oleic acid. Journal of Industrial and Engineering Chemistry (Washington, D.C.). 1950;42:1912-1919.

70. Vieville C, Mouloungui Z, and Gaset A. Synthesis and analysis of the C1 - C18 alkyl oleates. Chemistry and Physics of Lipids. 1995;75:(2):101-108.

71. Candy L, Vaca-Garcia C, and Borredon E. Synthesis and characterization of oleic succinic anhydrides: Structure-property relations. Journal of the American Oil Chemists' Society. 2005;82:(4):271-277.

72. Habulin M, Krmelj V, and Knez Z. Synthesis of oleic acid esters catalyzed by immobilized lipase. Journal of Agricultural and Food Chemistry. 1996;44:(1):338-342.

73. Tiwari NJ and Sawant SB. Behenic acid esters: kinetics and properties. European Journal of Lipid Science and Technology. 2005;107:(1):30-35.

74. Daneshfar A, Ghaziaskar HS, Shiri L, Manafi MH, Nikorazm M, and Abassi S. Synthesis of 2-ethylhexyl-2- ethylhexanoate catalyzed by immobilized lipase in n-hexane: A kinetic study. Biochemical Engineering Journal. 2007;37:(3):279-284.

CIR Panel Book Page 107 Distributed for Comment Only -- Do Not Cite or Quote

75. Cisko-Anic B, Majeric-Elenkov M, Hamersak Z, and Sunjic V. Combined biocatalytic preparation of (R)-2-ethylhexanol and 2-ethylhexyl laurate. Food Technology and Biotechnology. 1999;37:(1):65-70.

76. Sanna V, Mariani A, Caria G, and Sechi M. Synthesis and evaluation of different fatty acid esters formulated into Precirol ATO-based lipid nanoparticles as vehicles for topical delivery. Chemical & Pharmaceutical Bulletin. 2009;57:(7):680-684.

77. Syamsul KMW, Salina MR, Siti SO, Hanina MN., Basyaruddin MAR, and Jusoff K. Green synthesis of lauryl palmitate via lipase-catalyzed reaction. World Applied Sciences Journal. 2010;11:(4):401-407.

78. Iyengar, BTR and Schlenk H. Melting points of synthetic wax esters. Lipids. 1969;4:(1):28-30.

79. ACD/Labs. Advanced Chemistry Development (ACD/Labs) Software. 1994. (11.02):As cited in Chemical Abstracts Services Registry. Date Accessed 2012

80. Environmental Protection Agency. ACToR database. http://actor.epa.gov/actor. 1-4-2012. Date Accessed 1-4-2012.

81. Syracuse Research Corporation. "PhysProp" database. 2011.

82. Cosmetic, Toiletry, and Fragrance Association (CTFA). CTFA Compendium of Cosmetic Ingredient Composition: Descriptions. Washington, DC: CTFA, 1990.

83. Cataline EL, Worrell L, Jeffries SF, and Aronson SA. Water-in-oil emulsifying agents. II. Synthesis of some cholesteryl and cetyl esters. Journal of the American Pharmaceutical Association (1912-1977). 1944;33:107-108.

84. Kaufmann HP and Pollerberg J. The preparation of waxes from unsaturated fatty acids and alcohols. (Abstract). Fette, Seifen, Anstrichmittel. 1962;64:908-911.

85. Komppa G and Talvitie Y. Decyl series. (abstract). Journal fuer Praktische Chemie (Leipzig). 1932;135:193-203.

86. Paquot C, Sorba J ., and Wieme N. The physical properties of aliphatic esters containing eighteen carbon atoms. (abstract). Compt.rend.27e congr.intern.chim.ind., Brussels. 1955;3.

87. EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF). Scientific opinion. Flavouring Group Evaluation 7, Revision 3 (FGE.07Rev3): Saturated and unsaturated aliphatic secondary alcohols, ketones and esters of secondary alcohols and saturated linear or branched-chain carboxylic acids from chemical group 5. EFSA Journal. 2010;8:(12):1-71.

88. Zaar B. Limpricht-Piria reaction for the preparation of aldehydes. (Abstract). J prakt.Chim. 1931;132:163-168.

89. Kaufmann HP and Pollerberg J. The preparation of waxes from unsaturated fatty acids and alcohols. Fette, Seifen, Anstrichmittel. 1962;64:908-911.

90. Linko YY, Lamsa M, Huhtala A, and Rantanen O. Lipase biocatalysis in the production of esters. Journal of the American Oil Chemists' Society. 1995;72:(11):1293-1299.

CIR Panel Book Page 108 Data

Distributed for Comment Only -- Do Not Cite or Quote

ARACHIDYL BEHENATE 5 03B - Eyeliner ARACHIDYL BEHENATE 8 07C - Foundations ARACHIDYL BEHENATE 2 07E - Lipstick ARACHIDYL BEHENATE 1 07I - Other Makeup Preparations ARACHIDYL BEHENATE 2 12C - Face and Neck (exc shave) ARACHIDYL BEHENATE 2 12G - Night

ARACHIDYL PROPIONATE 1 03D - Eye Lotion ARACHIDYL PROPIONATE 2 03G - Other Eye Makeup Preparations ARACHIDYL PROPIONATE 2 05A - Hair Conditioner ARACHIDYL PROPIONATE 3 05G - Tonics, Dressings, and Other Hair Grooming Aids ARACHIDYL PROPIONATE 2 07C - Foundations ARACHIDYL PROPIONATE 6 07E - Lipstick ARACHIDYL PROPIONATE 1 07F - Makeup Bases ARACHIDYL PROPIONATE 1 10A - Bath Soaps and Detergents ARACHIDYL PROPIONATE 1 11A - Aftershave Lotion ARACHIDYL PROPIONATE 1 11E - Shaving Cream ARACHIDYL PROPIONATE 3 11G - Other Shaving Preparation Products ARACHIDYL PROPIONATE 2 12C - Face and Neck (exc shave) ARACHIDYL PROPIONATE 4 12D - Body and Hand (exc shave) ARACHIDYL PROPIONATE 6 12F - Moisturizing ARACHIDYL PROPIONATE 3 12G - Night ARACHIDYL PROPIONATE 2 12H - Paste Masks (mud packs) ARACHIDYL PROPIONATE 8 12J - Other Skin Care Preps

BEHENYL BEESWAX 1 03F - Mascara

BEHENYL BEHENATE 2 03D - Eye Lotion BEHENYL BEHENATE 1 12C - Face and Neck (exc shave) BEHENYL BEHENATE 1 12F - Moisturizing BEHENYL BEHENATE 1 12G - Night

BEHENYL ERUCATE 9 07E - Lipstick

BUTYL AVOCADATE 3 05F - Shampoos (non-coloring) BUTYL AVOCADATE 1 05I - Other Hair Preparations BUTYL AVOCADATE 1 07I - Other Makeup Preparations BUTYL AVOCADATE 1 11G - Other Shaving Preparation Products BUTYL AVOCADATE 2 12C - Face and Neck (exc shave) BUTYL AVOCADATE 1 12F - Moisturizing BUTYL AVOCADATE 1 13A - Suntan Gels, Creams, and Liquids

CIR Panel Book Page 109 Distributed for Comment Only -- Do Not Cite or Quote

BUTYL MYRISTATE 1 07H - Makeup Fixatives BUTYL MYRISTATE 2 07I - Other Makeup Preparations BUTYL MYRISTATE 1 12F - Moisturizing

BUTYL STEARATE 1 03A - Eyebrow Pencil BUTYL STEARATE 5 03B - Eyeliner BUTYL STEARATE 2 03C - Eye Shadow BUTYL STEARATE 2 03D - Eye Lotion BUTYL STEARATE 2 03G - Other Eye Makeup Preparations BUTYL STEARATE 1 05A - Hair Conditioner BUTYL STEARATE 1 05F - Shampoos (non-coloring) BUTYL STEARATE 1 05I - Other Hair Preparations BUTYL STEARATE 1 07A - Blushers (all types) BUTYL STEARATE 2 07B - Face Powders BUTYL STEARATE 2 07C - Foundations BUTYL STEARATE 17 07E - Lipstick BUTYL STEARATE 1 07I - Other Makeup Preparations BUTYL STEARATE 1 10A - Bath Soaps and Detergents BUTYL STEARATE 3 10E - Other Personal Cleanliness Products BUTYL STEARATE 4 12C - Face and Neck (exc shave) BUTYL STEARATE 5 12F - Moisturizing BUTYL STEARATE 1 12G - Night BUTYL STEARATE 1 12J - Other Skin Care Preps BUTYL STEARATE 1 13A - Suntan Gels, Creams, and Liquids BUTYL STEARATE 1 13B - Indoor Tanning Preparations

C12-13 ALKYL ETHYLHEXANOATE 1 03B - Eyeliner C12-13 ALKYL ETHYLHEXANOATE 2 03C - Eye Shadow C12-13 ALKYL ETHYLHEXANOATE 1 03G - Other Eye Makeup Preparations C12-13 ALKYL ETHYLHEXANOATE 2 07E - Lipstick C12-13 ALKYL ETHYLHEXANOATE 1 11A - Aftershave Lotion C12-13 ALKYL ETHYLHEXANOATE 1 12C - Face and Neck (exc shave)

C12-15 ALKYL ETHYLHEXANOATE 1 03C - Eye Shadow C12-15 ALKYL ETHYLHEXANOATE 1 03G - Other Eye Makeup Preparations C12-15 ALKYL ETHYLHEXANOATE 1 04E - Other Fragrance Preparation C12-15 ALKYL ETHYLHEXANOATE 1 07B - Face Powders C12-15 ALKYL ETHYLHEXANOATE 4 07C - Foundations C12-15 ALKYL ETHYLHEXANOATE 1 07I - Other Makeup Preparations C12-15 ALKYL ETHYLHEXANOATE 26 12D - Body and Hand (exc shave) C12-15 ALKYL ETHYLHEXANOATE 8 12F - Moisturizing C12-15 ALKYL ETHYLHEXANOATE 2 12G - Night

CIR Panel Book Page 110 Distributed for Comment Only -- Do Not Cite or Quote

C20-40 ALKYL STEARATE 3 05I - Other Hair Preparations C20-40 ALKYL STEARATE 8 07E - Lipstick

CAPRYLYL CAPRYLATE 1 03D - Eye Lotion CAPRYLYL CAPRYLATE 3 12C - Face and Neck (exc shave) CAPRYLYL CAPRYLATE 3 12D - Body and Hand (exc shave) CAPRYLYL CAPRYLATE 4 12F - Moisturizing

CAPRYLYL EICOSENOATE 1 12C - Face and Neck (exc shave) CAPRYLYL EICOSENOATE 1 12F - Moisturizing

CETEARYL BEHENATE 1 03B - Eyeliner CETEARYL BEHENATE 2 07I - Other Makeup Preparations

CETEARYL CANDELILLATE 1 07E - Lipstick CETEARYL CANDELILLATE 1 13C - Other Suntan Preparations

CETEARYL ETHYLHEXANOATE 2 02A - Bath Oils, Tablets, and Salts CETEARYL ETHYLHEXANOATE 1 02D - Other Bath Preparations CETEARYL ETHYLHEXANOATE 49 03C - Eye Shadow CETEARYL ETHYLHEXANOATE 3 03D - Eye Lotion CETEARYL ETHYLHEXANOATE 1 03E - Eye Makeup Remover CETEARYL ETHYLHEXANOATE 7 03G - Other Eye Makeup Preparations CETEARYL ETHYLHEXANOATE 2 04A - Cologne and Toilet waters CETEARYL ETHYLHEXANOATE 1 04C - Powders (dusting and talcum, excluding aftershave talc) CETEARYL ETHYLHEXANOATE 8 04E - Other Fragrance Preparation CETEARYL ETHYLHEXANOATE 1 05A - Hair Conditioner CETEARYL ETHYLHEXANOATE 2 05B - Hair Spray (aerosol fixatives) CETEARYL ETHYLHEXANOATE 19 05G - Tonics, Dressings, and Other Hair Grooming Aids CETEARYL ETHYLHEXANOATE 3 05I - Other Hair Preparations CETEARYL ETHYLHEXANOATE 13 07A - Blushers (all types) CETEARYL ETHYLHEXANOATE 20 07B - Face Powders CETEARYL ETHYLHEXANOATE 7 07C - Foundations CETEARYL ETHYLHEXANOATE 2 07E - Lipstick CETEARYL ETHYLHEXANOATE 1 07F - Makeup Bases CETEARYL ETHYLHEXANOATE 1 07G - Rouges CETEARYL ETHYLHEXANOATE 7 07I - Other Makeup Preparations CETEARYL ETHYLHEXANOATE 1 08G - Other Manicuring Preparations CETEARYL ETHYLHEXANOATE 2 10B - Deodorants (underarm) CETEARYL ETHYLHEXANOATE 38 11A - Aftershave Lotion CETEARYL ETHYLHEXANOATE 1 11C - Mens Talcum

CIR Panel Book Page 111 Distributed for Comment Only -- Do Not Cite or Quote

CETEARYL ETHYLHEXANOATE 3 11G - Other Shaving Preparation Products CETEARYL ETHYLHEXANOATE 8 12A - Cleansing CETEARYL ETHYLHEXANOATE 57 12C - Face and Neck (exc shave) CETEARYL ETHYLHEXANOATE 38 12D - Body and Hand (exc shave) CETEARYL ETHYLHEXANOATE 45 12F - Moisturizing CETEARYL ETHYLHEXANOATE 16 12G - Night CETEARYL ETHYLHEXANOATE 5 12H - Paste Masks (mud packs) CETEARYL ETHYLHEXANOATE 13 12J - Other Skin Care Preps CETEARYL ETHYLHEXANOATE 4 13A - Suntan Gels, Creams, and Liquids CETEARYL ETHYLHEXANOATE 1 13B - Indoor Tanning Preparations

CETEARYL ISONONANOATE 2 03B - Eyeliner CETEARYL ISONONANOATE 5 03C - Eye Shadow CETEARYL ISONONANOATE 4 03D - Eye Lotion CETEARYL ISONONANOATE 2 03E - Eye Makeup Remover CETEARYL ISONONANOATE 5 03G - Other Eye Makeup Preparations CETEARYL ISONONANOATE 2 04E - Other Fragrance Preparation CETEARYL ISONONANOATE 1 05E - Rinses (non-coloring) CETEARYL ISONONANOATE 2 05G - Tonics, Dressings, and Other Hair Grooming Aids CETEARYL ISONONANOATE 2 07A - Blushers (all types) CETEARYL ISONONANOATE 1 07B - Face Powders CETEARYL ISONONANOATE 3 07C - Foundations CETEARYL ISONONANOATE 1 07E - Lipstick CETEARYL ISONONANOATE 3 07F - Makeup Bases CETEARYL ISONONANOATE 1 07G - Rouges CETEARYL ISONONANOATE 3 07I - Other Makeup Preparations CETEARYL ISONONANOATE 1 08G - Other Manicuring Preparations CETEARYL ISONONANOATE 2 10E - Other Personal Cleanliness Products CETEARYL ISONONANOATE 1 11A - Aftershave Lotion CETEARYL ISONONANOATE 1 11D - Preshave Lotions (all types) CETEARYL ISONONANOATE 14 12A - Cleansing CETEARYL ISONONANOATE 24 12C - Face and Neck (exc shave) CETEARYL ISONONANOATE 17 12D - Body and Hand (exc shave) CETEARYL ISONONANOATE 1 12E - Foot Powders and Sprays CETEARYL ISONONANOATE 33 12F - Moisturizing CETEARYL ISONONANOATE 15 12G - Night CETEARYL ISONONANOATE 2 12H - Paste Masks (mud packs) CETEARYL ISONONANOATE 9 12J - Other Skin Care Preps CETEARYL ISONONANOATE 4 13B - Indoor Tanning Preparations CETEARYL ISONONANOATE 1 13C - Other Suntan Preparations

CETEARYL OLIVATE 1 01B - Baby Lotions, Oils, Powders, and Creams CETEARYL OLIVATE 8 03D - Eye Lotion CETEARYL OLIVATE 2 03F - Mascara CETEARYL OLIVATE 4 03G - Other Eye Makeup Preparations

CIR Panel Book Page 112 Distributed for Comment Only -- Do Not Cite or Quote

CETEARYL OLIVATE 2 05A - Hair Conditioner CETEARYL OLIVATE 1 05I - Other Hair Preparations CETEARYL OLIVATE 1 07C - Foundations CETEARYL OLIVATE 3 07F - Makeup Bases CETEARYL OLIVATE 1 07H - Makeup Fixatives CETEARYL OLIVATE 1 07I - Other Makeup Preparations CETEARYL OLIVATE 1 10B - Deodorants (underarm) CETEARYL OLIVATE 3 10E - Other Personal Cleanliness Products CETEARYL OLIVATE 2 11A - Aftershave Lotion CETEARYL OLIVATE 6 11E - Shaving Cream CETEARYL OLIVATE 18 12A - Cleansing CETEARYL OLIVATE 14 12C - Face and Neck (exc shave) CETEARYL OLIVATE 14 12D - Body and Hand (exc shave) CETEARYL OLIVATE 42 12F - Moisturizing CETEARYL OLIVATE 11 12G - Night CETEARYL OLIVATE 3 12H - Paste Masks (mud packs) CETEARYL OLIVATE 6 12J - Other Skin Care Preps CETEARYL OLIVATE 1 13A - Suntan Gels, Creams, and Liquids CETEARYL OLIVATE 1 13B - Indoor Tanning Preparations

CETEARYL STEARATE 1 07I - Other Makeup Preparations CETEARYL STEARATE 1 12C - Face and Neck (exc shave) CETEARYL STEARATE 1 12D - Body and Hand (exc shave)

CETYL BABASSUATE 1 07C - Foundations CETYL BABASSUATE 1 12C - Face and Neck (exc shave)

CETYL CAPRYLATE 2 01B - Baby Lotions, Oils, Powders, and Creams CETYL CAPRYLATE 1 03C - Eye Shadow CETYL CAPRYLATE 2 12A - Cleansing CETYL CAPRYLATE 5 12C - Face and Neck (exc shave) CETYL CAPRYLATE 1 12D - Body and Hand (exc shave) CETYL CAPRYLATE 3 12F - Moisturizing

CETYL ESTERS 1 01C - Other Baby Products CETYL ESTERS 1 03A - Eyebrow Pencil CETYL ESTERS 1 03C - Eye Shadow CETYL ESTERS 20 03D - Eye Lotion CETYL ESTERS 6 03G - Other Eye Makeup Preparations CETYL ESTERS 192 05A - Hair Conditioner CETYL ESTERS 1 05E - Rinses (non-coloring) CETYL ESTERS 1 05F - Shampoos (non-coloring) CETYL ESTERS 17 05G - Tonics, Dressings, and Other Hair Grooming Aids

CIR Panel Book Page 113 Distributed for Comment Only -- Do Not Cite or Quote

CETYL ESTERS 58 05I - Other Hair Preparations 06A - Hair Dyes and Colors (all types requiring caution 3 CETYL ESTERS statements and patch tests) CETYL ESTERS 2 06H - Other Hair Coloring Preparation CETYL ESTERS 1 07B - Face Powders CETYL ESTERS 7 07C - Foundations CETYL ESTERS 8 07E - Lipstick CETYL ESTERS 1 07F - Makeup Bases CETYL ESTERS 5 07I - Other Makeup Preparations CETYL ESTERS 2 10A - Bath Soaps and Detergents CETYL ESTERS 1 10B - Deodorants (underarm) CETYL ESTERS 1 10E - Other Personal Cleanliness Products CETYL ESTERS 1 11E - Shaving Cream CETYL ESTERS 14 12A - Cleansing CETYL ESTERS 9 12C - Face and Neck (exc shave) CETYL ESTERS 32 12D - Body and Hand (exc shave) CETYL ESTERS 43 12F - Moisturizing CETYL ESTERS 8 12G - Night CETYL ESTERS 7 12H - Paste Masks (mud packs) CETYL ESTERS 4 12J - Other Skin Care Preps CETYL ESTERS 2 13A - Suntan Gels, Creams, and Liquids CETYL ESTERS 3 13B - Indoor Tanning Preparations

CETYL ETHYLHEXANOATE 4 03A - Eyebrow Pencil CETYL ETHYLHEXANOATE 9 03B - Eyeliner CETYL ETHYLHEXANOATE 15 03C - Eye Shadow CETYL ETHYLHEXANOATE 4 03D - Eye Lotion CETYL ETHYLHEXANOATE 6 03E - Eye Makeup Remover CETYL ETHYLHEXANOATE 50 05A - Hair Conditioner CETYL ETHYLHEXANOATE 4 05G - Tonics, Dressings, and Other Hair Grooming Aids CETYL ETHYLHEXANOATE 5 05I - Other Hair Preparations CETYL ETHYLHEXANOATE 1 06C - Hair Rinses (coloring) CETYL ETHYLHEXANOATE 5 07A - Blushers (all types) CETYL ETHYLHEXANOATE 4 07B - Face Powders CETYL ETHYLHEXANOATE 6 07C - Foundations CETYL ETHYLHEXANOATE 15 07E - Lipstick CETYL ETHYLHEXANOATE 15 07F - Makeup Bases CETYL ETHYLHEXANOATE 1 07G - Rouges CETYL ETHYLHEXANOATE 5 07I - Other Makeup Preparations CETYL ETHYLHEXANOATE 2 10E - Other Personal Cleanliness Products CETYL ETHYLHEXANOATE 2 11D - Preshave Lotions (all types) CETYL ETHYLHEXANOATE 17 12A - Cleansing CETYL ETHYLHEXANOATE 25 12C - Face and Neck (exc shave) CETYL ETHYLHEXANOATE 18 12D - Body and Hand (exc shave) CETYL ETHYLHEXANOATE 27 12F - Moisturizing CETYL ETHYLHEXANOATE 5 12G - Night

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CETYL ETHYLHEXANOATE 1 12I - Skin Fresheners CETYL ETHYLHEXANOATE 8 12J - Other Skin Care Preps CETYL ETHYLHEXANOATE 2 13A - Suntan Gels, Creams, and Liquids CETYL ETHYLHEXANOATE 4 13B - Indoor Tanning Preparations CETYL ETHYLHEXANOATE 2 13C - Other Suntan Preparations

CETYL LAURATE 1 12D - Body and Hand (exc shave)

CETYL MYRISTATE 1 03C - Eye Shadow CETYL MYRISTATE 1 12D - Body and Hand (exc shave) CETYL MYRISTATE 1 12F - Moisturizing CETYL MYRISTATE 1 12J - Other Skin Care Preps

CETYL PALMITATE 7 03A - Eyebrow Pencil CETYL PALMITATE 16 03B - Eyeliner CETYL PALMITATE 3 03C - Eye Shadow CETYL PALMITATE 8 03D - Eye Lotion CETYL PALMITATE 2 03E - Eye Makeup Remover CETYL PALMITATE 11 03G - Other Eye Makeup Preparations CETYL PALMITATE 2 04B - Perfumes CETYL PALMITATE 5 04E - Other Fragrance Preparation CETYL PALMITATE 3 05A - Hair Conditioner CETYL PALMITATE 1 05E - Rinses (non-coloring) CETYL PALMITATE 4 05F - Shampoos (non-coloring) CETYL PALMITATE 2 05G - Tonics, Dressings, and Other Hair Grooming Aids CETYL PALMITATE 3 07A - Blushers (all types) CETYL PALMITATE 8 07C - Foundations CETYL PALMITATE 22 07E - Lipstick CETYL PALMITATE 1 07F - Makeup Bases CETYL PALMITATE 5 07I - Other Makeup Preparations CETYL PALMITATE 1 08C - Nail Creams and Lotions CETYL PALMITATE 1 08G - Other Manicuring Preparations CETYL PALMITATE 2 10B - Deodorants (underarm) CETYL PALMITATE 4 10E - Other Personal Cleanliness Products CETYL PALMITATE 3 11A - Aftershave Lotion CETYL PALMITATE 1 11E - Shaving Cream CETYL PALMITATE 1 11G - Other Shaving Preparation Products CETYL PALMITATE 23 12A - Cleansing CETYL PALMITATE 60 12C - Face and Neck (exc shave) CETYL PALMITATE 127 12D - Body and Hand (exc shave) CETYL PALMITATE 94 12F - Moisturizing CETYL PALMITATE 19 12G - Night CETYL PALMITATE 4 12H - Paste Masks (mud packs) CETYL PALMITATE 5 12I - Skin Fresheners

CIR Panel Book Page 115 Distributed for Comment Only -- Do Not Cite or Quote

CETYL PALMITATE 17 12J - Other Skin Care Preps CETYL PALMITATE 4 13A - Suntan Gels, Creams, and Liquids CETYL PALMITATE 3 13B - Indoor Tanning Preparations CETYL PALMITATE 2 13C - Other Suntan Preparations

CETYL RICINOLEATE 10 03D - Eye Lotion CETYL RICINOLEATE 2 03G - Other Eye Makeup Preparations CETYL RICINOLEATE 1 07A - Blushers (all types) CETYL RICINOLEATE 4 07B - Face Powders CETYL RICINOLEATE 4 07C - Foundations CETYL RICINOLEATE 32 07E - Lipstick CETYL RICINOLEATE 7 12A - Cleansing CETYL RICINOLEATE 8 12C - Face and Neck (exc shave) CETYL RICINOLEATE 5 12D - Body and Hand (exc shave) CETYL RICINOLEATE 36 12F - Moisturizing CETYL RICINOLEATE 11 12G - Night CETYL RICINOLEATE 2 12H - Paste Masks (mud packs) CETYL RICINOLEATE 7 12J - Other Skin Care Preps CETYL RICINOLEATE 1 13B - Indoor Tanning Preparations

CETYL STEARATE 1 03A - Eyebrow Pencil CETYL STEARATE 1 03C - Eye Shadow CETYL STEARATE 1 12D - Body and Hand (exc shave) CETYL STEARATE 2 12F - Moisturizing

CETYL TALLOWATE 1 12J - Other Skin Care Preps

COCO-CAPRYLATE 1 03G - Other Eye Makeup Preparations COCO-CAPRYLATE 2 12C - Face and Neck (exc shave) COCO-CAPRYLATE 2 12G - Night

COCO-CAPRYLATE/CAPRATE 6 02A - Bath Oils, Tablets, and Salts COCO-CAPRYLATE/CAPRATE 1 03A - Eyebrow Pencil COCO-CAPRYLATE/CAPRATE 1 03B - Eyeliner COCO-CAPRYLATE/CAPRATE 13 03C - Eye Shadow COCO-CAPRYLATE/CAPRATE 2 03D - Eye Lotion COCO-CAPRYLATE/CAPRATE 9 03G - Other Eye Makeup Preparations COCO-CAPRYLATE/CAPRATE 1 04E - Other Fragrance Preparation COCO-CAPRYLATE/CAPRATE 1 05A - Hair Conditioner COCO-CAPRYLATE/CAPRATE 3 07A - Blushers (all types) COCO-CAPRYLATE/CAPRATE 1 07B - Face Powders COCO-CAPRYLATE/CAPRATE 4 07C - Foundations

CIR Panel Book Page 116 Distributed for Comment Only -- Do Not Cite or Quote

COCO-CAPRYLATE/CAPRATE 2 07E - Lipstick COCO-CAPRYLATE/CAPRATE 2 07F - Makeup Bases COCO-CAPRYLATE/CAPRATE 4 07I - Other Makeup Preparations COCO-CAPRYLATE/CAPRATE 1 10E - Other Personal Cleanliness Products COCO-CAPRYLATE/CAPRATE 2 11A - Aftershave Lotion COCO-CAPRYLATE/CAPRATE 2 11D - Preshave Lotions (all types) COCO-CAPRYLATE/CAPRATE 1 11G - Other Shaving Preparation Products COCO-CAPRYLATE/CAPRATE 14 12A - Cleansing COCO-CAPRYLATE/CAPRATE 25 12C - Face and Neck (exc shave) COCO-CAPRYLATE/CAPRATE 57 12D - Body and Hand (exc shave) COCO-CAPRYLATE/CAPRATE 42 12F - Moisturizing COCO-CAPRYLATE/CAPRATE 10 12G - Night COCO-CAPRYLATE/CAPRATE 3 12H - Paste Masks (mud packs) COCO-CAPRYLATE/CAPRATE 2 12I - Skin Fresheners COCO-CAPRYLATE/CAPRATE 9 12J - Other Skin Care Preps COCO-CAPRYLATE/CAPRATE 1 13A - Suntan Gels, Creams, and Liquids COCO-CAPRYLATE/CAPRATE 12 13B - Indoor Tanning Preparations COCO-CAPRYLATE/CAPRATE 1 13C - Other Suntan Preparations

DECYL COCOATE 2 12A - Cleansing DECYL COCOATE 3 12C - Face and Neck (exc shave)

DECYL OLEATE 4 03D - Eye Lotion DECYL OLEATE 1 03G - Other Eye Makeup Preparations DECYL OLEATE 1 04E - Other Fragrance Preparation DECYL OLEATE 4 05A - Hair Conditioner DECYL OLEATE 6 05G - Tonics, Dressings, and Other Hair Grooming Aids DECYL OLEATE 1 07C - Foundations DECYL OLEATE 2 07D - Leg and Body Paints DECYL OLEATE 1 07F - Makeup Bases DECYL OLEATE 1 07I - Other Makeup Preparations DECYL OLEATE 1 08C - Nail Creams and Lotions DECYL OLEATE 1 10B - Deodorants (underarm) DECYL OLEATE 2 11A - Aftershave Lotion DECYL OLEATE 7 12A - Cleansing DECYL OLEATE 35 12C - Face and Neck (exc shave) DECYL OLEATE 54 12D - Body and Hand (exc shave) DECYL OLEATE 54 12F - Moisturizing DECYL OLEATE 12 12G - Night DECYL OLEATE 4 12H - Paste Masks (mud packs) DECYL OLEATE 9 12J - Other Skin Care Preps

DECYL OLIVATE 1 12D - Body and Hand (exc shave)

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ETHYLHEXYL COCOATE 1 03C - Eye Shadow ETHYLHEXYL COCOATE 7 03D - Eye Lotion ETHYLHEXYL COCOATE 2 03G - Other Eye Makeup Preparations ETHYLHEXYL COCOATE 1 05A - Hair Conditioner ETHYLHEXYL COCOATE 1 05G - Tonics, Dressings, and Other Hair Grooming Aids ETHYLHEXYL COCOATE 4 07C - Foundations ETHYLHEXYL COCOATE 4 07E - Lipstick ETHYLHEXYL COCOATE 3 07F - Makeup Bases ETHYLHEXYL COCOATE 2 08E - Nail Polish and Enamel ETHYLHEXYL COCOATE 1 08G - Other Manicuring Preparations ETHYLHEXYL COCOATE 1 10E - Other Personal Cleanliness Products ETHYLHEXYL COCOATE 1 11A - Aftershave Lotion ETHYLHEXYL COCOATE 8 12A - Cleansing ETHYLHEXYL COCOATE 10 12C - Face and Neck (exc shave) ETHYLHEXYL COCOATE 9 12D - Body and Hand (exc shave) ETHYLHEXYL COCOATE 15 12F - Moisturizing ETHYLHEXYL COCOATE 4 12G - Night ETHYLHEXYL COCOATE 2 12H - Paste Masks (mud packs) ETHYLHEXYL COCOATE 2 12J - Other Skin Care Preps ETHYLHEXYL COCOATE 2 13A - Suntan Gels, Creams, and Liquids ETHYLHEXYL COCOATE 9 13B - Indoor Tanning Preparations

ETHYLHEXYL ETHYLHEXANOATE 1 03D - Eye Lotion ETHYLHEXYL ETHYLHEXANOATE 1 11A - Aftershave Lotion ETHYLHEXYL ETHYLHEXANOATE 2 12C - Face and Neck (exc shave) ETHYLHEXYL ETHYLHEXANOATE 13 12D - Body and Hand (exc shave) ETHYLHEXYL ETHYLHEXANOATE 1 12G - Night ETHYLHEXYL ETHYLHEXANOATE 2 12J - Other Skin Care Preps

ETHYLHEXYL HYDROXYSTEARATE 5 03B - Eyeliner ETHYLHEXYL HYDROXYSTEARATE 6 03C - Eye Shadow ETHYLHEXYL HYDROXYSTEARATE 4 03D - Eye Lotion ETHYLHEXYL HYDROXYSTEARATE 1 03G - Other Eye Makeup Preparations ETHYLHEXYL HYDROXYSTEARATE 3 05F - Shampoos (non-coloring) ETHYLHEXYL HYDROXYSTEARATE 1 05G - Tonics, Dressings, and Other Hair Grooming Aids ETHYLHEXYL HYDROXYSTEARATE 6 07A - Blushers (all types) ETHYLHEXYL HYDROXYSTEARATE 1 07B - Face Powders ETHYLHEXYL HYDROXYSTEARATE 6 07C - Foundations ETHYLHEXYL HYDROXYSTEARATE 79 07E - Lipstick ETHYLHEXYL HYDROXYSTEARATE 9 07G - Rouges ETHYLHEXYL HYDROXYSTEARATE 28 07I - Other Makeup Preparations ETHYLHEXYL HYDROXYSTEARATE 9 10A - Bath Soaps and Detergents ETHYLHEXYL HYDROXYSTEARATE 3 10E - Other Personal Cleanliness Products ETHYLHEXYL HYDROXYSTEARATE 8 12A - Cleansing

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ETHYLHEXYL HYDROXYSTEARATE 3 12C - Face and Neck (exc shave) ETHYLHEXYL HYDROXYSTEARATE 43 12D - Body and Hand (exc shave) ETHYLHEXYL HYDROXYSTEARATE 2 12E - Foot Powders and Sprays ETHYLHEXYL HYDROXYSTEARATE 25 12F - Moisturizing ETHYLHEXYL HYDROXYSTEARATE 3 12G - Night ETHYLHEXYL HYDROXYSTEARATE 2 12H - Paste Masks (mud packs) ETHYLHEXYL HYDROXYSTEARATE 5 12J - Other Skin Care Preps ETHYLHEXYL HYDROXYSTEARATE 1 13C - Other Suntan Preparations

ETHYLHEXYL ISONONANOATE 2 03D - Eye Lotion ETHYLHEXYL ISONONANOATE 4 03G - Other Eye Makeup Preparations ETHYLHEXYL ISONONANOATE 3 04E - Other Fragrance Preparation ETHYLHEXYL ISONONANOATE 4 05G - Tonics, Dressings, and Other Hair Grooming Aids ETHYLHEXYL ISONONANOATE 1 05I - Other Hair Preparations ETHYLHEXYL ISONONANOATE 2 07A - Blushers (all types) ETHYLHEXYL ISONONANOATE 2 07B - Face Powders ETHYLHEXYL ISONONANOATE 2 07C - Foundations ETHYLHEXYL ISONONANOATE 1 07E - Lipstick ETHYLHEXYL ISONONANOATE 1 07H - Makeup Fixatives ETHYLHEXYL ISONONANOATE 2 07I - Other Makeup Preparations ETHYLHEXYL ISONONANOATE 1 10E - Other Personal Cleanliness Products ETHYLHEXYL ISONONANOATE 6 11A - Aftershave Lotion ETHYLHEXYL ISONONANOATE 1 11G - Other Shaving Preparation Products ETHYLHEXYL ISONONANOATE 1 12A - Cleansing ETHYLHEXYL ISONONANOATE 4 12C - Face and Neck (exc shave) ETHYLHEXYL ISONONANOATE 39 12D - Body and Hand (exc shave) ETHYLHEXYL ISONONANOATE 23 12F - Moisturizing ETHYLHEXYL ISONONANOATE 9 12G - Night ETHYLHEXYL ISONONANOATE 4 12J - Other Skin Care Preps ETHYLHEXYL ISONONANOATE 1 13A - Suntan Gels, Creams, and Liquids ETHYLHEXYL ISONONANOATE 23 13B - Indoor Tanning Preparations ETHYLHEXYL ISONONANOATE 1 13C - Other Suntan Preparations

ETHYLHEXYL ISOPALMITATE 1 03C - Eye Shadow ETHYLHEXYL ISOPALMITATE 1 07I - Other Makeup Preparations ETHYLHEXYL ISOPALMITATE 1 12C - Face and Neck (exc shave) ETHYLHEXYL ISOPALMITATE 3 12D - Body and Hand (exc shave) ETHYLHEXYL ISOPALMITATE 1 13C - Other Suntan Preparations

ETHYLHEXYL ISOSTEARATE 2 03A - Eyebrow Pencil ETHYLHEXYL ISOSTEARATE 4 03B - Eyeliner

Ethylhexyl Laurate:

CIR Panel Book Page 119 Distributed for Comment Only -- Do Not Cite or Quote

OCTYL LAURATE 1 12C - Face and Neck (exc shave)

ETHYLHEXYL MYRISTATE 1 12A - Cleansing ETHYLHEXYL MYRISTATE 1 12F - Moisturizing

ETHYLHEXYL OLIVATE 1 03G - Other Eye Makeup Preparations ETHYLHEXYL OLIVATE 1 12F - Moisturizing

ETHYLHEXYL PALMITATE 2 01B - Baby Lotions, Oils, Powders, and Creams ETHYLHEXYL PALMITATE 1 02A - Bath Oils, Tablets, and Salts ETHYLHEXYL PALMITATE 2 03A - Eyebrow Pencil ETHYLHEXYL PALMITATE 13 03B - Eyeliner ETHYLHEXYL PALMITATE 125 03C - Eye Shadow ETHYLHEXYL PALMITATE 17 03D - Eye Lotion ETHYLHEXYL PALMITATE 1 03F - Mascara ETHYLHEXYL PALMITATE 30 03G - Other Eye Makeup Preparations ETHYLHEXYL PALMITATE 1 04A - Cologne and Toilet waters ETHYLHEXYL PALMITATE 8 04B - Perfumes ETHYLHEXYL PALMITATE 1 04C - Powders (dusting and talcum, excluding aftershave talc) ETHYLHEXYL PALMITATE 13 04E - Other Fragrance Preparation ETHYLHEXYL PALMITATE 6 05A - Hair Conditioner ETHYLHEXYL PALMITATE 4 05F - Shampoos (non-coloring) ETHYLHEXYL PALMITATE 5 05G - Tonics, Dressings, and Other Hair Grooming Aids ETHYLHEXYL PALMITATE 2 05I - Other Hair Preparations ETHYLHEXYL PALMITATE 47 07A - Blushers (all types) ETHYLHEXYL PALMITATE 58 07B - Face Powders ETHYLHEXYL PALMITATE 39 07C - Foundations ETHYLHEXYL PALMITATE 1 07D - Leg and Body Paints ETHYLHEXYL PALMITATE 199 07E - Lipstick ETHYLHEXYL PALMITATE 15 07F - Makeup Bases ETHYLHEXYL PALMITATE 2 07H - Makeup Fixatives ETHYLHEXYL PALMITATE 62 07I - Other Makeup Preparations ETHYLHEXYL PALMITATE 1 08A - Basecoats and Undercoats ETHYLHEXYL PALMITATE 3 08B - Cuticle Softeners ETHYLHEXYL PALMITATE 2 08C - Nail Creams and Lotions ETHYLHEXYL PALMITATE 1 08F - Nail Polish and Enamel Removers ETHYLHEXYL PALMITATE 8 08G - Other Manicuring Preparations ETHYLHEXYL PALMITATE 5 10B - Deodorants (underarm) ETHYLHEXYL PALMITATE 4 10E - Other Personal Cleanliness Products ETHYLHEXYL PALMITATE 3 11A - Aftershave Lotion ETHYLHEXYL PALMITATE 4 11E - Shaving Cream ETHYLHEXYL PALMITATE 17 12A - Cleansing ETHYLHEXYL PALMITATE 58 12C - Face and Neck (exc shave) ETHYLHEXYL PALMITATE 97 12D - Body and Hand (exc shave)

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ETHYLHEXYL PALMITATE 2 12E - Foot Powders and Sprays ETHYLHEXYL PALMITATE 170 12F - Moisturizing ETHYLHEXYL PALMITATE 19 12G - Night ETHYLHEXYL PALMITATE 6 12H - Paste Masks (mud packs) ETHYLHEXYL PALMITATE 1 12I - Skin Fresheners ETHYLHEXYL PALMITATE 35 12J - Other Skin Care Preps ETHYLHEXYL PALMITATE 6 13A - Suntan Gels, Creams, and Liquids ETHYLHEXYL PALMITATE 13 13B - Indoor Tanning Preparations ETHYLHEXYL PALMITATE 4 13C - Other Suntan Preparations OCTYL PALMITATE 1 02A - Bath Oils, Tablets, and Salts OCTYL PALMITATE 1 03A - Eyebrow Pencil OCTYL PALMITATE 84 03C - Eye Shadow OCTYL PALMITATE 1 03E - Eye Makeup Remover OCTYL PALMITATE 7 03G - Other Eye Makeup Preparations OCTYL PALMITATE 1 05A - Hair Conditioner OCTYL PALMITATE 8 07A - Blushers (all types) OCTYL PALMITATE 6 07B - Face Powders OCTYL PALMITATE 4 07C - Foundations OCTYL PALMITATE 1 07D - Leg and Body Paints OCTYL PALMITATE 11 07E - Lipstick OCTYL PALMITATE 9 07I - Other Makeup Preparations OCTYL PALMITATE 1 10B - Deodorants (underarm) OCTYL PALMITATE 6 12A - Cleansing OCTYL PALMITATE 7 12C - Face and Neck (exc shave) OCTYL PALMITATE 10 12D - Body and Hand (exc shave) OCTYL PALMITATE 12 12F - Moisturizing OCTYL PALMITATE 5 12G - Night OCTYL PALMITATE 6 12J - Other Skin Care Preps OCTYL PALMITATE 1 13A - Suntan Gels, Creams, and Liquids OCTYL PALMITATE 3 13B - Indoor Tanning Preparations

ETHYLHEXYL PELARGONATE 1 07A - Blushers (all types) ETHYLHEXYL PELARGONATE 1 07C - Foundations ETHYLHEXYL PELARGONATE 1 12A - Cleansing

ETHYLHEXYL STEARATE 5 02A - Bath Oils, Tablets, and Salts ETHYLHEXYL STEARATE 7 03A - Eyebrow Pencil ETHYLHEXYL STEARATE 3 03B - Eyeliner ETHYLHEXYL STEARATE 12 03C - Eye Shadow ETHYLHEXYL STEARATE 4 03D - Eye Lotion ETHYLHEXYL STEARATE 1 03E - Eye Makeup Remover ETHYLHEXYL STEARATE 11 03G - Other Eye Makeup Preparations ETHYLHEXYL STEARATE 3 04B - Perfumes ETHYLHEXYL STEARATE 3 04E - Other Fragrance Preparation ETHYLHEXYL STEARATE 1 05B - Hair Spray (aerosol fixatives)

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ETHYLHEXYL STEARATE 8 05G - Tonics, Dressings, and Other Hair Grooming Aids ETHYLHEXYL STEARATE 4 07A - Blushers (all types) ETHYLHEXYL STEARATE 9 07B - Face Powders ETHYLHEXYL STEARATE 7 07C - Foundations ETHYLHEXYL STEARATE 6 07E - Lipstick ETHYLHEXYL STEARATE 1 07F - Makeup Bases ETHYLHEXYL STEARATE 9 07I - Other Makeup Preparations ETHYLHEXYL STEARATE 4 10E - Other Personal Cleanliness Products ETHYLHEXYL STEARATE 3 11A - Aftershave Lotion ETHYLHEXYL STEARATE 3 11E - Shaving Cream ETHYLHEXYL STEARATE 12 12A - Cleansing ETHYLHEXYL STEARATE 17 12C - Face and Neck (exc shave) ETHYLHEXYL STEARATE 56 12D - Body and Hand (exc shave) ETHYLHEXYL STEARATE 57 12F - Moisturizing ETHYLHEXYL STEARATE 15 12G - Night ETHYLHEXYL STEARATE 2 12H - Paste Masks (mud packs) ETHYLHEXYL STEARATE 10 12J - Other Skin Care Preps ETHYLHEXYL STEARATE 2 13A - Suntan Gels, Creams, and Liquids ETHYLHEXYL STEARATE 6 13B - Indoor Tanning Preparations OCTYL STEARATE 1 03G - Other Eye Makeup Preparations OCTYL STEARATE 1 07C - Foundations OCTYL STEARATE 1 07F - Makeup Bases OCTYL STEARATE 4 12A - Cleansing OCTYL STEARATE 3 12C - Face and Neck (exc shave) OCTYL STEARATE 5 12D - Body and Hand (exc shave) OCTYL STEARATE 11 12F - Moisturizing OCTYL STEARATE 1 12H - Paste Masks (mud packs) OCTYL STEARATE 3 12I - Skin Fresheners OCTYL STEARATE 6 12J - Other Skin Care Preps OCTYL STEARATE 1 13B - Indoor Tanning Preparations

HEPTYL UNDECYLENATE 3 03G - Other Eye Makeup Preparations

HEPTYLUNDECYL HYDROXYSTEARATE 8 03C - Eye Shadow HEPTYLUNDECYL HYDROXYSTEARATE 2 07E - Lipstick

HEXYL LAURATE 3 01B - Baby Lotions, Oils, Powders, and Creams HEXYL LAURATE 1 03C - Eye Shadow HEXYL LAURATE 2 03D - Eye Lotion HEXYL LAURATE 4 03F - Mascara HEXYL LAURATE 9 03G - Other Eye Makeup Preparations HEXYL LAURATE 2 05G - Tonics, Dressings, and Other Hair Grooming Aids HEXYL LAURATE 5 07A - Blushers (all types) HEXYL LAURATE 1 07B - Face Powders

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HEXYL LAURATE 61 07C - Foundations HEXYL LAURATE 2 07D - Leg and Body Paints HEXYL LAURATE 15 07E - Lipstick HEXYL LAURATE 15 07F - Makeup Bases HEXYL LAURATE 1 07G - Rouges HEXYL LAURATE 2 07H - Makeup Fixatives HEXYL LAURATE 21 07I - Other Makeup Preparations HEXYL LAURATE 1 08G - Other Manicuring Preparations HEXYL LAURATE 1 11A - Aftershave Lotion HEXYL LAURATE 1 12A - Cleansing HEXYL LAURATE 8 12C - Face and Neck (exc shave) HEXYL LAURATE 5 12F - Moisturizing HEXYL LAURATE 2 12H - Paste Masks (mud packs) HEXYL LAURATE 8 12J - Other Skin Care Preps HEXYL LAURATE 4 13A - Suntan Gels, Creams, and Liquids HEXYL LAURATE 7 13B - Indoor Tanning Preparations HEXYL LAURATE 1 13C - Other Suntan Preparations

HEXYLDECYL LAURATE 2 03D - Eye Lotion HEXYLDECYL LAURATE 1 05A - Hair Conditioner HEXYLDECYL LAURATE 4 12A - Cleansing HEXYLDECYL LAURATE 8 12C - Face and Neck (exc shave) HEXYLDECYL LAURATE 14 12D - Body and Hand (exc shave) HEXYLDECYL LAURATE 5 12F - Moisturizing HEXYLDECYL LAURATE 3 12G - Night HEXYLDECYL LAURATE 1 12H - Paste Masks (mud packs) HEXYLDECYL LAURATE 1 12J - Other Skin Care Preps

HEXYLDECYL STEARATE 1 03D - Eye Lotion HEXYLDECYL STEARATE 1 03G - Other Eye Makeup Preparations HEXYLDECYL STEARATE 1 07C - Foundations HEXYLDECYL STEARATE 1 11A - Aftershave Lotion HEXYLDECYL STEARATE 7 12A - Cleansing HEXYLDECYL STEARATE 1 12C - Face and Neck (exc shave) HEXYLDECYL STEARATE 6 12D - Body and Hand (exc shave) HEXYLDECYL STEARATE 6 12F - Moisturizing HEXYLDECYL STEARATE 4 12G - Night HEXYLDECYL STEARATE 2 12H - Paste Masks (mud packs) HEXYLDECYL STEARATE 2 12J - Other Skin Care Preps

HYDROGENATED ETHYLHEXYL OLIVATE 2 03C - Eye Shadow HYDROGENATED ETHYLHEXYL OLIVATE 1 05A - Hair Conditioner HYDROGENATED ETHYLHEXYL OLIVATE 2 07C - Foundations HYDROGENATED ETHYLHEXYL OLIVATE 1 12C - Face and Neck (exc shave)

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HYDROGENATED ETHYLHEXYL OLIVATE 1 12G - Night

HYDROXYOCTACOSANYL HYDROXYSTEARATE 1 03G - Other Eye Makeup Preparations HYDROXYOCTACOSANYL HYDROXYSTEARATE 1 12F - Moisturizing HYDROXYOCTACOSANYL HYDROXYSTEARATE 3 12G - Night

Isocetyl Ethylhexanoate: CETYL OCTANOATE, ISO 1 03D - Eye Lotion CETYL OCTANOATE, ISO 2 07C - Foundations CETYL OCTANOATE, ISO 1 07E - Lipstick CETYL OCTANOATE, ISO 3 12C - Face and Neck (exc shave) CETYL OCTANOATE, ISO 1 12F - Moisturizing

ISOCETYL MYRISTATE 1 03C - Eye Shadow ISOCETYL MYRISTATE 2 03D - Eye Lotion ISOCETYL MYRISTATE 1 07B - Face Powders ISOCETYL MYRISTATE 1 12C - Face and Neck (exc shave) ISOCETYL MYRISTATE 1 12D - Body and Hand (exc shave) ISOCETYL MYRISTATE 2 12F - Moisturizing ISOCETYL MYRISTATE 1 12H - Paste Masks (mud packs) ISOCETYL MYRISTATE 1 12J - Other Skin Care Preps

ISOCETYL PALMITATE 1 07A - Blushers (all types) ISOCETYL PALMITATE 3 07C - Foundations ISOCETYL PALMITATE 1 07I - Other Makeup Preparations

ISOCETYL STEARATE 1 03D - Eye Lotion ISOCETYL STEARATE 1 03G - Other Eye Makeup Preparations ISOCETYL STEARATE 2 04E - Other Fragrance Preparation ISOCETYL STEARATE 8 05A - Hair Conditioner ISOCETYL STEARATE 4 07A - Blushers (all types) ISOCETYL STEARATE 4 07B - Face Powders ISOCETYL STEARATE 8 07C - Foundations ISOCETYL STEARATE 14 07E - Lipstick ISOCETYL STEARATE 5 07I - Other Makeup Preparations ISOCETYL STEARATE 1 10E - Other Personal Cleanliness Products ISOCETYL STEARATE 2 11A - Aftershave Lotion ISOCETYL STEARATE 4 12A - Cleansing ISOCETYL STEARATE 4 12C - Face and Neck (exc shave) ISOCETYL STEARATE 66 12D - Body and Hand (exc shave) ISOCETYL STEARATE 68 12F - Moisturizing ISOCETYL STEARATE 2 12G - Night

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ISOCETYL STEARATE 7 12J - Other Skin Care Preps ISOCETYL STEARATE 1 13B - Indoor Tanning Preparations

ISODECYL ISONONANOATE 1 03B - Eyeliner ISODECYL ISONONANOATE 4 03C - Eye Shadow ISODECYL ISONONANOATE 1 03D - Eye Lotion ISODECYL ISONONANOATE 1 03E - Eye Makeup Remover ISODECYL ISONONANOATE 1 03G - Other Eye Makeup Preparations ISODECYL ISONONANOATE 4 07A - Blushers (all types) ISODECYL ISONONANOATE 1 07C - Foundations ISODECYL ISONONANOATE 4 07E - Lipstick ISODECYL ISONONANOATE 3 07I - Other Makeup Preparations ISODECYL ISONONANOATE 4 12C - Face and Neck (exc shave) ISODECYL ISONONANOATE 6 12F - Moisturizing ISODECYL ISONONANOATE 1 12G - Night ISODECYL ISONONANOATE 2 12H - Paste Masks (mud packs) ISODECYL ISONONANOATE 1 12J - Other Skin Care Preps ISODECYL ISONONANOATE 1 13B - Indoor Tanning Preparations ISODECYL ISONONANOATE 1 13C - Other Suntan Preparations

ISODECYL LAURATE 1 03E - Eye Makeup Remover ISODECYL LAURATE 1 03G - Other Eye Makeup Preparations ISODECYL LAURATE 1 12A - Cleansing ISODECYL LAURATE 1 12H - Paste Masks (mud packs)

ISODECYL MYRISTATE 1 03D - Eye Lotion

ISODECYL NEOPENTANOATE 8 03B - Eyeliner ISODECYL NEOPENTANOATE 8 03C - Eye Shadow ISODECYL NEOPENTANOATE 3 03D - Eye Lotion ISODECYL NEOPENTANOATE 1 03F - Mascara ISODECYL NEOPENTANOATE 5 03G - Other Eye Makeup Preparations ISODECYL NEOPENTANOATE 1 05H - Wave Sets ISODECYL NEOPENTANOATE 3 07A - Blushers (all types) ISODECYL NEOPENTANOATE 4 07B - Face Powders ISODECYL NEOPENTANOATE 14 07C - Foundations ISODECYL NEOPENTANOATE 8 07E - Lipstick ISODECYL NEOPENTANOATE 1 07F - Makeup Bases ISODECYL NEOPENTANOATE 1 07G - Rouges ISODECYL NEOPENTANOATE 7 07I - Other Makeup Preparations ISODECYL NEOPENTANOATE 1 11A - Aftershave Lotion ISODECYL NEOPENTANOATE 1 11G - Other Shaving Preparation Products ISODECYL NEOPENTANOATE 2 12A - Cleansing

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ISODECYL NEOPENTANOATE 11 12C - Face and Neck (exc shave) ISODECYL NEOPENTANOATE 12 12D - Body and Hand (exc shave) ISODECYL NEOPENTANOATE 19 12F - Moisturizing ISODECYL NEOPENTANOATE 5 12G - Night ISODECYL NEOPENTANOATE 1 12H - Paste Masks (mud packs) ISODECYL NEOPENTANOATE 3 12J - Other Skin Care Preps ISODECYL NEOPENTANOATE 4 13A - Suntan Gels, Creams, and Liquids ISODECYL NEOPENTANOATE 3 13B - Indoor Tanning Preparations

ISODECYL OLEATE 3 05B - Hair Spray (aerosol fixatives) ISODECYL OLEATE 6 05G - Tonics, Dressings, and Other Hair Grooming Aids ISODECYL OLEATE 1 05I - Other Hair Preparations ISODECYL OLEATE 1 08G - Other Manicuring Preparations ISODECYL OLEATE 1 12A - Cleansing ISODECYL OLEATE 3 12F - Moisturizing

Isohexyl Caprate: ISOHEXYL DECANOATE 3 07I - Other Makeup Preparations

ISONONYL ISONONANOATE 1 03B - Eyeliner ISONONYL ISONONANOATE 43 03C - Eye Shadow ISONONYL ISONONANOATE 12 03D - Eye Lotion ISONONYL ISONONANOATE 5 03E - Eye Makeup Remover ISONONYL ISONONANOATE 19 03G - Other Eye Makeup Preparations ISONONYL ISONONANOATE 9 04B - Perfumes ISONONYL ISONONANOATE 7 04E - Other Fragrance Preparation ISONONYL ISONONANOATE 1 05G - Tonics, Dressings, and Other Hair Grooming Aids ISONONYL ISONONANOATE 2 05I - Other Hair Preparations ISONONYL ISONONANOATE 33 07A - Blushers (all types) ISONONYL ISONONANOATE 28 07B - Face Powders ISONONYL ISONONANOATE 50 07C - Foundations ISONONYL ISONONANOATE 2 07D - Leg and Body Paints ISONONYL ISONONANOATE 47 07E - Lipstick ISONONYL ISONONANOATE 5 07F - Makeup Bases ISONONYL ISONONANOATE 3 07G - Rouges ISONONYL ISONONANOATE 3 07H - Makeup Fixatives ISONONYL ISONONANOATE 27 07I - Other Makeup Preparations ISONONYL ISONONANOATE 1 08C - Nail Creams and Lotions ISONONYL ISONONANOATE 1 08G - Other Manicuring Preparations ISONONYL ISONONANOATE 1 10B - Deodorants (underarm) ISONONYL ISONONANOATE 1 10E - Other Personal Cleanliness Products ISONONYL ISONONANOATE 13 11A - Aftershave Lotion ISONONYL ISONONANOATE 1 11G - Other Shaving Preparation Products ISONONYL ISONONANOATE 13 12A - Cleansing

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ISONONYL ISONONANOATE 56 12C - Face and Neck (exc shave) ISONONYL ISONONANOATE 86 12D - Body and Hand (exc shave) ISONONYL ISONONANOATE 74 12F - Moisturizing ISONONYL ISONONANOATE 18 12G - Night ISONONYL ISONONANOATE 3 12H - Paste Masks (mud packs) ISONONYL ISONONANOATE 2 12I - Skin Fresheners ISONONYL ISONONANOATE 28 12J - Other Skin Care Preps ISONONYL ISONONANOATE 2 13A - Suntan Gels, Creams, and Liquids ISONONYL ISONONANOATE 12 13B - Indoor Tanning Preparations ISONONYL ISONONANOATE 2 13C - Other Suntan Preparations

ISOPROPYL ISOSTEARATE 2 01B - Baby Lotions, Oils, Powders, and Creams ISOPROPYL ISOSTEARATE 10 03B - Eyeliner ISOPROPYL ISOSTEARATE 46 03C - Eye Shadow ISOPROPYL ISOSTEARATE 1 03D - Eye Lotion ISOPROPYL ISOSTEARATE 2 03G - Other Eye Makeup Preparations ISOPROPYL ISOSTEARATE 1 04C - Powders (dusting and talcum, excluding aftershave talc) ISOPROPYL ISOSTEARATE 1 05F - Shampoos (non-coloring) ISOPROPYL ISOSTEARATE 2 05I - Other Hair Preparations ISOPROPYL ISOSTEARATE 4 07A - Blushers (all types) ISOPROPYL ISOSTEARATE 15 07B - Face Powders ISOPROPYL ISOSTEARATE 6 07C - Foundations ISOPROPYL ISOSTEARATE 18 07E - Lipstick ISOPROPYL ISOSTEARATE 3 07F - Makeup Bases ISOPROPYL ISOSTEARATE 1 07H - Makeup Fixatives ISOPROPYL ISOSTEARATE 3 07I - Other Makeup Preparations ISOPROPYL ISOSTEARATE 1 10A - Bath Soaps and Detergents ISOPROPYL ISOSTEARATE 1 11E - Shaving Cream ISOPROPYL ISOSTEARATE 7 12A - Cleansing ISOPROPYL ISOSTEARATE 8 12C - Face and Neck (exc shave) ISOPROPYL ISOSTEARATE 8 12D - Body and Hand (exc shave) ISOPROPYL ISOSTEARATE 56 12F - Moisturizing ISOPROPYL ISOSTEARATE 6 12G - Night ISOPROPYL ISOSTEARATE 3 12H - Paste Masks (mud packs) ISOPROPYL ISOSTEARATE 13 12J - Other Skin Care Preps ISOPROPYL ISOSTEARATE 1 13A - Suntan Gels, Creams, and Liquids ISOPROPYL ISOSTEARATE 6 13B - Indoor Tanning Preparations

ISOPROPYL JOJOBATE 2 03D - Eye Lotion ISOPROPYL JOJOBATE 1 03G - Other Eye Makeup Preparations ISOPROPYL JOJOBATE 3 07E - Lipstick ISOPROPYL JOJOBATE 10 12D - Body and Hand (exc shave) ISOPROPYL JOJOBATE 4 12F - Moisturizing ISOPROPYL JOJOBATE 1 12J - Other Skin Care Preps ISOPROPYL JOJOBATE 1 13C - Other Suntan Preparations

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ISOPROPYL MYRISTATE 6 01B - Baby Lotions, Oils, Powders, and Creams ISOPROPYL MYRISTATE 14 02A - Bath Oils, Tablets, and Salts ISOPROPYL MYRISTATE 1 02D - Other Bath Preparations ISOPROPYL MYRISTATE 17 03A - Eyebrow Pencil ISOPROPYL MYRISTATE 47 03B - Eyeliner ISOPROPYL MYRISTATE 45 03C - Eye Shadow ISOPROPYL MYRISTATE 4 03D - Eye Lotion ISOPROPYL MYRISTATE 2 03E - Eye Makeup Remover ISOPROPYL MYRISTATE 15 03G - Other Eye Makeup Preparations ISOPROPYL MYRISTATE 8 04A - Cologne and Toilet waters ISOPROPYL MYRISTATE 4 04B - Perfumes ISOPROPYL MYRISTATE 2 04C - Powders (dusting and talcum, excluding aftershave talc) ISOPROPYL MYRISTATE 22 04E - Other Fragrance Preparation ISOPROPYL MYRISTATE 46 05A - Hair Conditioner ISOPROPYL MYRISTATE 5 05B - Hair Spray (aerosol fixatives) ISOPROPYL MYRISTATE 2 05C - Hair Straighteners ISOPROPYL MYRISTATE 8 05F - Shampoos (non-coloring) ISOPROPYL MYRISTATE 44 05G - Tonics, Dressings, and Other Hair Grooming Aids ISOPROPYL MYRISTATE 38 05I - Other Hair Preparations 06A - Hair Dyes and Colors (all types requiring caution 18 ISOPROPYL MYRISTATE statements and patch tests) ISOPROPYL MYRISTATE 3 06G - Hair Bleaches ISOPROPYL MYRISTATE 33 07A - Blushers (all types) ISOPROPYL MYRISTATE 16 07B - Face Powders ISOPROPYL MYRISTATE 22 07C - Foundations ISOPROPYL MYRISTATE 2 07D - Leg and Body Paints ISOPROPYL MYRISTATE 53 07E - Lipstick ISOPROPYL MYRISTATE 3 07F - Makeup Bases ISOPROPYL MYRISTATE 2 07G - Rouges ISOPROPYL MYRISTATE 25 07I - Other Makeup Preparations ISOPROPYL MYRISTATE 5 08B - Cuticle Softeners ISOPROPYL MYRISTATE 1 08C - Nail Creams and Lotions ISOPROPYL MYRISTATE 1 08F - Nail Polish and Enamel Removers ISOPROPYL MYRISTATE 2 08G - Other Manicuring Preparations ISOPROPYL MYRISTATE 20 10A - Bath Soaps and Detergents ISOPROPYL MYRISTATE 20 10B - Deodorants (underarm) ISOPROPYL MYRISTATE 8 10D - Feminine Deodorants ISOPROPYL MYRISTATE 15 10E - Other Personal Cleanliness Products ISOPROPYL MYRISTATE 9 11A - Aftershave Lotion ISOPROPYL MYRISTATE 4 11D - Preshave Lotions (all types) ISOPROPYL MYRISTATE 6 11E - Shaving Cream ISOPROPYL MYRISTATE 3 11F - Shaving Soap ISOPROPYL MYRISTATE 3 11G - Other Shaving Preparation Products ISOPROPYL MYRISTATE 61 12A - Cleansing ISOPROPYL MYRISTATE 1 12B - Depilatories

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ISOPROPYL MYRISTATE 71 12C - Face and Neck (exc shave) ISOPROPYL MYRISTATE 166 12D - Body and Hand (exc shave) ISOPROPYL MYRISTATE 4 12E - Foot Powders and Sprays ISOPROPYL MYRISTATE 148 12F - Moisturizing ISOPROPYL MYRISTATE 18 12G - Night ISOPROPYL MYRISTATE 9 12H - Paste Masks (mud packs) ISOPROPYL MYRISTATE 40 12J - Other Skin Care Preps ISOPROPYL MYRISTATE 18 13A - Suntan Gels, Creams, and Liquids ISOPROPYL MYRISTATE 8 13B - Indoor Tanning Preparations ISOPROPYL MYRISTATE 1 13C - Other Suntan Preparations

ISOPROPYL PALMITATE 4 01B - Baby Lotions, Oils, Powders, and Creams ISOPROPYL PALMITATE 26 02A - Bath Oils, Tablets, and Salts ISOPROPYL PALMITATE 3 03A - Eyebrow Pencil ISOPROPYL PALMITATE 12 03B - Eyeliner ISOPROPYL PALMITATE 35 03C - Eye Shadow ISOPROPYL PALMITATE 5 03D - Eye Lotion ISOPROPYL PALMITATE 9 03E - Eye Makeup Remover ISOPROPYL PALMITATE 8 03G - Other Eye Makeup Preparations ISOPROPYL PALMITATE 2 04A - Cologne and Toilet waters ISOPROPYL PALMITATE 1 04B - Perfumes ISOPROPYL PALMITATE 25 04E - Other Fragrance Preparation ISOPROPYL PALMITATE 14 05A - Hair Conditioner ISOPROPYL PALMITATE 1 05B - Hair Spray (aerosol fixatives) ISOPROPYL PALMITATE 3 05C - Hair Straighteners ISOPROPYL PALMITATE 1 05F - Shampoos (non-coloring) ISOPROPYL PALMITATE 14 05G - Tonics, Dressings, and Other Hair Grooming Aids ISOPROPYL PALMITATE 19 05I - Other Hair Preparations ISOPROPYL PALMITATE 9 07A - Blushers (all types) ISOPROPYL PALMITATE 26 07B - Face Powders ISOPROPYL PALMITATE 15 07C - Foundations ISOPROPYL PALMITATE 1 07D - Leg and Body Paints ISOPROPYL PALMITATE 104 07E - Lipstick ISOPROPYL PALMITATE 5 07F - Makeup Bases ISOPROPYL PALMITATE 1 07H - Makeup Fixatives ISOPROPYL PALMITATE 14 07I - Other Makeup Preparations ISOPROPYL PALMITATE 7 08B - Cuticle Softeners ISOPROPYL PALMITATE 3 08C - Nail Creams and Lotions ISOPROPYL PALMITATE 1 08F - Nail Polish and Enamel Removers ISOPROPYL PALMITATE 3 08G - Other Manicuring Preparations ISOPROPYL PALMITATE 2 10A - Bath Soaps and Detergents ISOPROPYL PALMITATE 15 10B - Deodorants (underarm) ISOPROPYL PALMITATE 7 10E - Other Personal Cleanliness Products ISOPROPYL PALMITATE 7 11A - Aftershave Lotion ISOPROPYL PALMITATE 3 11E - Shaving Cream ISOPROPYL PALMITATE 7 11G - Other Shaving Preparation Products

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ISOPROPYL PALMITATE 28 12A - Cleansing ISOPROPYL PALMITATE 37 12C - Face and Neck (exc shave) ISOPROPYL PALMITATE 157 12D - Body and Hand (exc shave) ISOPROPYL PALMITATE 3 12E - Foot Powders and Sprays ISOPROPYL PALMITATE 285 12F - Moisturizing ISOPROPYL PALMITATE 9 12G - Night ISOPROPYL PALMITATE 10 12H - Paste Masks (mud packs) ISOPROPYL PALMITATE 4 12I - Skin Fresheners ISOPROPYL PALMITATE 39 12J - Other Skin Care Preps ISOPROPYL PALMITATE 2 13A - Suntan Gels, Creams, and Liquids ISOPROPYL PALMITATE 12 13B - Indoor Tanning Preparations ISOPROPYL PALMITATE 1 13C - Other Suntan Preparations

ISOPROPYL STEARATE 1 03G - Other Eye Makeup Preparations ISOPROPYL STEARATE 1 10B - Deodorants (underarm) ISOPROPYL STEARATE 1 12A - Cleansing ISOPROPYL STEARATE 7 12F - Moisturizing

ISOSTEARYL AVOCADATE 1 12D - Body and Hand (exc shave)

ISOSTEARYL BEHENATE 1 07C - Foundations ISOSTEARYL BEHENATE 1 07F - Makeup Bases ISOSTEARYL BEHENATE 4 07I - Other Makeup Preparations ISOSTEARYL BEHENATE 1 12F - Moisturizing

ISOSTEARYL HYDROXYSTEARATE 7 03C - Eye Shadow ISOSTEARYL HYDROXYSTEARATE 3 07A - Blushers (all types) ISOSTEARYL HYDROXYSTEARATE 3 07B - Face Powders ISOSTEARYL HYDROXYSTEARATE 7 07E - Lipstick ISOSTEARYL HYDROXYSTEARATE 1 12G - Night

ISOSTEARYL ISONONANOATE 3 08D - Nail Extenders ISOSTEARYL ISONONANOATE 1 08F - Nail Polish and Enamel Removers

ISOSTEARYL ISOSTEARATE 1 02A - Bath Oils, Tablets, and Salts ISOSTEARYL ISOSTEARATE 1 03D - Eye Lotion ISOSTEARYL ISOSTEARATE 2 03G - Other Eye Makeup Preparations ISOSTEARYL ISOSTEARATE 1 04E - Other Fragrance Preparation ISOSTEARYL ISOSTEARATE 2 07A - Blushers (all types) ISOSTEARYL ISOSTEARATE 1 07C - Foundations ISOSTEARYL ISOSTEARATE 114 07E - Lipstick

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ISOSTEARYL ISOSTEARATE 2 07I - Other Makeup Preparations ISOSTEARYL ISOSTEARATE 5 12A - Cleansing ISOSTEARYL ISOSTEARATE 15 12C - Face and Neck (exc shave) ISOSTEARYL ISOSTEARATE 11 12D - Body and Hand (exc shave) ISOSTEARYL ISOSTEARATE 14 12F - Moisturizing ISOSTEARYL ISOSTEARATE 7 12G - Night ISOSTEARYL ISOSTEARATE 7 12H - Paste Masks (mud packs) ISOSTEARYL ISOSTEARATE 11 12J - Other Skin Care Preps

ISOSTEARYL LINOLEATE 1 07B - Face Powders ISOSTEARYL LINOLEATE 1 12D - Body and Hand (exc shave)

ISOSTEARYL MYRISTATE 1 12F - Moisturizing

ISOSTEARYL NEOPENTANOATE 4 03B - Eyeliner ISOSTEARYL NEOPENTANOATE 49 03C - Eye Shadow ISOSTEARYL NEOPENTANOATE 18 03D - Eye Lotion ISOSTEARYL NEOPENTANOATE 7 03G - Other Eye Makeup Preparations ISOSTEARYL NEOPENTANOATE 3 04E - Other Fragrance Preparation ISOSTEARYL NEOPENTANOATE 1 05A - Hair Conditioner ISOSTEARYL NEOPENTANOATE 11 05F - Shampoos (non-coloring) ISOSTEARYL NEOPENTANOATE 1 05I - Other Hair Preparations ISOSTEARYL NEOPENTANOATE 11 07A - Blushers (all types) ISOSTEARYL NEOPENTANOATE 34 07B - Face Powders ISOSTEARYL NEOPENTANOATE 16 07C - Foundations ISOSTEARYL NEOPENTANOATE 8 07E - Lipstick ISOSTEARYL NEOPENTANOATE 2 07F - Makeup Bases ISOSTEARYL NEOPENTANOATE 1 07H - Makeup Fixatives ISOSTEARYL NEOPENTANOATE 12 07I - Other Makeup Preparations ISOSTEARYL NEOPENTANOATE 1 08E - Nail Polish and Enamel ISOSTEARYL NEOPENTANOATE 1 11A - Aftershave Lotion ISOSTEARYL NEOPENTANOATE 1 12A - Cleansing ISOSTEARYL NEOPENTANOATE 10 12C - Face and Neck (exc shave) ISOSTEARYL NEOPENTANOATE 6 12D - Body and Hand (exc shave) ISOSTEARYL NEOPENTANOATE 13 12F - Moisturizing ISOSTEARYL NEOPENTANOATE 4 12G - Night ISOSTEARYL NEOPENTANOATE 2 12H - Paste Masks (mud packs) ISOSTEARYL NEOPENTANOATE 8 12J - Other Skin Care Preps ISOSTEARYL NEOPENTANOATE 1 13B - Indoor Tanning Preparations

ISOSTEARYL PALMITATE 3 03C - Eye Shadow ISOSTEARYL PALMITATE 4 03E - Eye Makeup Remover ISOSTEARYL PALMITATE 1 05A - Hair Conditioner

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ISOSTEARYL PALMITATE 3 05G - Tonics, Dressings, and Other Hair Grooming Aids ISOSTEARYL PALMITATE 2 05I - Other Hair Preparations ISOSTEARYL PALMITATE 1 07A - Blushers (all types) ISOSTEARYL PALMITATE 8 07B - Face Powders ISOSTEARYL PALMITATE 6 07C - Foundations ISOSTEARYL PALMITATE 3 07E - Lipstick ISOSTEARYL PALMITATE 2 12A - Cleansing ISOSTEARYL PALMITATE 2 12C - Face and Neck (exc shave) ISOSTEARYL PALMITATE 1 12D - Body and Hand (exc shave) ISOSTEARYL PALMITATE 6 12F - Moisturizing ISOSTEARYL PALMITATE 3 12G - Night ISOSTEARYL PALMITATE 1 12J - Other Skin Care Preps ISOSTEARYL PALMITATE 2 13A - Suntan Gels, Creams, and Liquids

ISOTRIDECYL ISONONANOATE 2 03C - Eye Shadow ISOTRIDECYL ISONONANOATE 3 03G - Other Eye Makeup Preparations ISOTRIDECYL ISONONANOATE 18 07A - Blushers (all types) ISOTRIDECYL ISONONANOATE 6 07B - Face Powders ISOTRIDECYL ISONONANOATE 12 07C - Foundations ISOTRIDECYL ISONONANOATE 17 07E - Lipstick ISOTRIDECYL ISONONANOATE 2 07G - Rouges ISOTRIDECYL ISONONANOATE 3 07I - Other Makeup Preparations ISOTRIDECYL ISONONANOATE 7 12C - Face and Neck (exc shave) ISOTRIDECYL ISONONANOATE 4 12F - Moisturizing ISOTRIDECYL ISONONANOATE 3 13A - Suntan Gels, Creams, and Liquids

ISOTRIDECYL STEARATE 1 03D - Eye Lotion

LAURYL LAURATE 1 03C - Eye Shadow LAURYL LAURATE 1 03D - Eye Lotion LAURYL LAURATE 2 04B - Perfumes LAURYL LAURATE 1 05G - Tonics, Dressings, and Other Hair Grooming Aids LAURYL LAURATE 1 07A - Blushers (all types) LAURYL LAURATE 1 07C - Foundations LAURYL LAURATE 1 07E - Lipstick LAURYL LAURATE 3 07I - Other Makeup Preparations LAURYL LAURATE 1 08C - Nail Creams and Lotions LAURYL LAURATE 3 12C - Face and Neck (exc shave) LAURYL LAURATE 7 12D - Body and Hand (exc shave) LAURYL LAURATE 1 12E - Foot Powders and Sprays LAURYL LAURATE 5 12F - Moisturizing LAURYL LAURATE 2 12G - Night

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LAURYL PALMITATE 1 05A - Hair Conditioner LAURYL PALMITATE 1 07I - Other Makeup Preparations

MYRISTYL LAURATE 1 03G - Other Eye Makeup Preparations MYRISTYL LAURATE 1 07E - Lipstick MYRISTYL LAURATE 1 12A - Cleansing MYRISTYL LAURATE 1 12C - Face and Neck (exc shave) MYRISTYL LAURATE 1 12D - Body and Hand (exc shave) MYRISTYL LAURATE 4 12F - Moisturizing MYRISTYL LAURATE 1 12J - Other Skin Care Preps

MYRISTYL MYRISTATE 4 01B - Baby Lotions, Oils, Powders, and Creams MYRISTYL MYRISTATE 4 02A - Bath Oils, Tablets, and Salts MYRISTYL MYRISTATE 8 03A - Eyebrow Pencil MYRISTYL MYRISTATE 22 03B - Eyeliner MYRISTYL MYRISTATE 11 03C - Eye Shadow MYRISTYL MYRISTATE 9 03D - Eye Lotion MYRISTYL MYRISTATE 8 03G - Other Eye Makeup Preparations MYRISTYL MYRISTATE 8 04E - Other Fragrance Preparation MYRISTYL MYRISTATE 13 05A - Hair Conditioner MYRISTYL MYRISTATE 1 05C - Hair Straighteners MYRISTYL MYRISTATE 3 05G - Tonics, Dressings, and Other Hair Grooming Aids MYRISTYL MYRISTATE 4 07A - Blushers (all types) MYRISTYL MYRISTATE 6 07C - Foundations MYRISTYL MYRISTATE 2 07D - Leg and Body Paints MYRISTYL MYRISTATE 30 07E - Lipstick MYRISTYL MYRISTATE 4 07F - Makeup Bases MYRISTYL MYRISTATE 6 07I - Other Makeup Preparations MYRISTYL MYRISTATE 1 08C - Nail Creams and Lotions MYRISTYL MYRISTATE 14 10B - Deodorants (underarm) MYRISTYL MYRISTATE 1 10E - Other Personal Cleanliness Products MYRISTYL MYRISTATE 4 11A - Aftershave Lotion MYRISTYL MYRISTATE 8 11E - Shaving Cream MYRISTYL MYRISTATE 7 12A - Cleansing MYRISTYL MYRISTATE 29 12C - Face and Neck (exc shave) MYRISTYL MYRISTATE 59 12D - Body and Hand (exc shave) MYRISTYL MYRISTATE 2 12E - Foot Powders and Sprays MYRISTYL MYRISTATE 95 12F - Moisturizing MYRISTYL MYRISTATE 19 12G - Night MYRISTYL MYRISTATE 6 12H - Paste Masks (mud packs) MYRISTYL MYRISTATE 9 12J - Other Skin Care Preps MYRISTYL MYRISTATE 5 13B - Indoor Tanning Preparations

OCTYLDODECYL ERUCATE 1 07I - Other Makeup Preparations

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OCTYLDODECYL HYDROXYSTEARATE 1 03C - Eye Shadow

OCTYLDODECYL ISOSTEARATE 1 07E - Lipstick

OCTYLDODECYL MYRISTATE 2 01B - Baby Lotions, Oils, Powders, and Creams OCTYLDODECYL MYRISTATE 1 03B - Eyeliner OCTYLDODECYL MYRISTATE 10 03C - Eye Shadow OCTYLDODECYL MYRISTATE 1 03D - Eye Lotion OCTYLDODECYL MYRISTATE 2 03F - Mascara OCTYLDODECYL MYRISTATE 2 03G - Other Eye Makeup Preparations OCTYLDODECYL MYRISTATE 1 04E - Other Fragrance Preparation OCTYLDODECYL MYRISTATE 2 05G - Tonics, Dressings, and Other Hair Grooming Aids OCTYLDODECYL MYRISTATE 1 07B - Face Powders OCTYLDODECYL MYRISTATE 15 07C - Foundations OCTYLDODECYL MYRISTATE 19 07E - Lipstick OCTYLDODECYL MYRISTATE 1 07G - Rouges OCTYLDODECYL MYRISTATE 2 11A - Aftershave Lotion OCTYLDODECYL MYRISTATE 2 11D - Preshave Lotions (all types) OCTYLDODECYL MYRISTATE 3 12A - Cleansing OCTYLDODECYL MYRISTATE 11 12C - Face and Neck (exc shave) OCTYLDODECYL MYRISTATE 14 12D - Body and Hand (exc shave) OCTYLDODECYL MYRISTATE 28 12F - Moisturizing OCTYLDODECYL MYRISTATE 3 12G - Night OCTYLDODECYL MYRISTATE 7 12H - Paste Masks (mud packs) OCTYLDODECYL MYRISTATE 5 12J - Other Skin Care Preps OCTYLDODECYL MYRISTATE 10 13B - Indoor Tanning Preparations

OCTYLDODECYL NEOPENTANOATE 17 03C - Eye Shadow OCTYLDODECYL NEOPENTANOATE 1 03D - Eye Lotion OCTYLDODECYL NEOPENTANOATE 2 03G - Other Eye Makeup Preparations OCTYLDODECYL NEOPENTANOATE 1 05A - Hair Conditioner OCTYLDODECYL NEOPENTANOATE 1 05G - Tonics, Dressings, and Other Hair Grooming Aids OCTYLDODECYL NEOPENTANOATE 7 05I - Other Hair Preparations OCTYLDODECYL NEOPENTANOATE 1 07A - Blushers (all types) OCTYLDODECYL NEOPENTANOATE 1 07B - Face Powders OCTYLDODECYL NEOPENTANOATE 8 07C - Foundations OCTYLDODECYL NEOPENTANOATE 16 07E - Lipstick OCTYLDODECYL NEOPENTANOATE 3 07I - Other Makeup Preparations OCTYLDODECYL NEOPENTANOATE 1 11A - Aftershave Lotion OCTYLDODECYL NEOPENTANOATE 9 12C - Face and Neck (exc shave) OCTYLDODECYL NEOPENTANOATE 2 12D - Body and Hand (exc shave) OCTYLDODECYL NEOPENTANOATE 1 12E - Foot Powders and Sprays

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OCTYLDODECYL NEOPENTANOATE 26 12F - Moisturizing OCTYLDODECYL NEOPENTANOATE 2 12G - Night OCTYLDODECYL NEOPENTANOATE 1 12H - Paste Masks (mud packs) OCTYLDODECYL NEOPENTANOATE 1 12J - Other Skin Care Preps OCTYLDODECYL NEOPENTANOATE 1 13A - Suntan Gels, Creams, and Liquids OCTYLDODECYL NEOPENTANOATE 2 13B - Indoor Tanning Preparations OCTYLDODECYL NEOPENTANOATE 3 13C - Other Suntan Preparations

OCTYLDODECYL OCTYLDODECANOATE 1 12C - Face and Neck (exc shave)

OCTYLDODECYL OLIVATE 1 03D - Eye Lotion OCTYLDODECYL OLIVATE 1 03G - Other Eye Makeup Preparations OCTYLDODECYL OLIVATE 7 12F - Moisturizing OCTYLDODECYL OLIVATE 1 12G - Night OCTYLDODECYL OLIVATE 1 12J - Other Skin Care Preps

OCTYLDODECYL RICINOLEATE 4 05A - Hair Conditioner OCTYLDODECYL RICINOLEATE 1 05F - Shampoos (non-coloring) OCTYLDODECYL RICINOLEATE 3 05I - Other Hair Preparations OCTYLDODECYL RICINOLEATE 2 07G - Rouges OCTYLDODECYL RICINOLEATE 1 12C - Face and Neck (exc shave)

OCTYLDODECYL STEARATE 21 03C - Eye Shadow OCTYLDODECYL STEARATE 1 04C - Powders (dusting and talcum, excluding aftershave talc) OCTYLDODECYL STEARATE 3 07A - Blushers (all types) OCTYLDODECYL STEARATE 2 07E - Lipstick OCTYLDODECYL STEARATE 1 07G - Rouges OCTYLDODECYL STEARATE 1 07I - Other Makeup Preparations

OLEYL ERUCATE 1 03D - Eye Lotion OLEYL ERUCATE 1 05F - Shampoos (non-coloring) OLEYL ERUCATE 16 07E - Lipstick OLEYL ERUCATE 1 07I - Other Makeup Preparations OLEYL ERUCATE 1 10E - Other Personal Cleanliness Products OLEYL ERUCATE 2 12A - Cleansing OLEYL ERUCATE 7 12C - Face and Neck (exc shave) OLEYL ERUCATE 2 12D - Body and Hand (exc shave) OLEYL ERUCATE 1 12F - Moisturizing OLEYL ERUCATE 4 12J - Other Skin Care Preps OLEYL ERUCATE 6 13A - Suntan Gels, Creams, and Liquids OLEYL ERUCATE 2 13B - Indoor Tanning Preparations

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OLEYL OLEATE 3 03C - Eye Shadow OLEYL OLEATE 3 07B - Face Powders OLEYL OLEATE 4 07E - Lipstick OLEYL OLEATE 1 12A - Cleansing

PROPYLHEPTYL CAPRYLATE 1 05A - Hair Conditioner PROPYLHEPTYL CAPRYLATE 1 07C - Foundations PROPYLHEPTYL CAPRYLATE 9 07E - Lipstick PROPYLHEPTYL CAPRYLATE 5 12C - Face and Neck (exc shave) PROPYLHEPTYL CAPRYLATE 5 12F - Moisturizing PROPYLHEPTYL CAPRYLATE 1 12G - Night PROPYLHEPTYL CAPRYLATE 2 13B - Indoor Tanning Preparations

STEARYL BEESWAX 1 12A - Cleansing STEARYL BEESWAX 2 12C - Face and Neck (exc shave) STEARYL BEESWAX 5 12D - Body and Hand (exc shave) STEARYL BEESWAX 1 12G - Night STEARYL BEESWAX 1 12J - Other Skin Care Preps

STEARYL CAPRYLATE 1 03D - Eye Lotion STEARYL CAPRYLATE 4 03G - Other Eye Makeup Preparations STEARYL CAPRYLATE 2 07C - Foundations STEARYL CAPRYLATE 2 07E - Lipstick STEARYL CAPRYLATE 1 07I - Other Makeup Preparations STEARYL CAPRYLATE 1 10E - Other Personal Cleanliness Products STEARYL CAPRYLATE 4 12C - Face and Neck (exc shave) STEARYL CAPRYLATE 1 12D - Body and Hand (exc shave) STEARYL CAPRYLATE 4 12F - Moisturizing STEARYL CAPRYLATE 6 12G - Night STEARYL CAPRYLATE 2 12J - Other Skin Care Preps

STEARYL ETHYLHEXANOATE 2 05I - Other Hair Preparations STEARYL ETHYLHEXANOATE 1 07C - Foundations STEARYL ETHYLHEXANOATE 1 07E - Lipstick STEARYL ETHYLHEXANOATE 2 07F - Makeup Bases STEARYL ETHYLHEXANOATE 1 07I - Other Makeup Preparations STEARYL ETHYLHEXANOATE 1 12F - Moisturizing

STEARYL HEPTANOATE 9 03B - Eyeliner STEARYL HEPTANOATE 2 03D - Eye Lotion STEARYL HEPTANOATE 7 03G - Other Eye Makeup Preparations

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STEARYL HEPTANOATE 1 05B - Hair Spray (aerosol fixatives) STEARYL HEPTANOATE 1 05I - Other Hair Preparations STEARYL HEPTANOATE 3 07C - Foundations STEARYL HEPTANOATE 11 07E - Lipstick STEARYL HEPTANOATE 1 07F - Makeup Bases STEARYL HEPTANOATE 3 07I - Other Makeup Preparations STEARYL HEPTANOATE 1 10A - Bath Soaps and Detergents STEARYL HEPTANOATE 2 10E - Other Personal Cleanliness Products STEARYL HEPTANOATE 12 12C - Face and Neck (exc shave) STEARYL HEPTANOATE 17 12D - Body and Hand (exc shave) STEARYL HEPTANOATE 12 12F - Moisturizing STEARYL HEPTANOATE 8 12G - Night STEARYL HEPTANOATE 1 12H - Paste Masks (mud packs) STEARYL HEPTANOATE 4 12J - Other Skin Care Preps

STEARYL OLIVATE 1 10A - Bath Soaps and Detergents STEARYL OLIVATE 1 12A - Cleansing STEARYL OLIVATE 1 12J - Other Skin Care Preps

STEARYL STEARATE 5 03F - Mascara STEARYL STEARATE 1 04B - Perfumes STEARYL STEARATE 1 04E - Other Fragrance Preparation STEARYL STEARATE 2 05G - Tonics, Dressings, and Other Hair Grooming Aids STEARYL STEARATE 1 07C - Foundations STEARYL STEARATE 1 07D - Leg and Body Paints STEARYL STEARATE 5 07E - Lipstick STEARYL STEARATE 1 07H - Makeup Fixatives STEARYL STEARATE 2 07I - Other Makeup Preparations STEARYL STEARATE 1 10A - Bath Soaps and Detergents STEARYL STEARATE 1 10E - Other Personal Cleanliness Products STEARYL STEARATE 2 12D - Body and Hand (exc shave) STEARYL STEARATE 1 12F - Moisturizing STEARYL STEARATE 2 12J - Other Skin Care Preps

TETRADECYLOCTADECYL STEARATE 1 12F - Moisturizing

Tridecyl Ethylhexanoate: TRIDECYL OCTANOATE 1 04E - Other Fragrance Preparation TRIDECYL OCTANOATE 1 07B - Face Powders TRIDECYL OCTANOATE 1 07I - Other Makeup Preparations TRIDECYL OCTANOATE 1 12F - Moisturizing

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TRIDECYL ISONONANOATE 1 07C - Foundations

TRIDECYL NEOPENTANOATE 10 03C - Eye Shadow TRIDECYL NEOPENTANOATE 1 07C - Foundations TRIDECYL NEOPENTANOATE 2 07E - Lipstick TRIDECYL NEOPENTANOATE 1 07F - Makeup Bases TRIDECYL NEOPENTANOATE 1 12A - Cleansing TRIDECYL NEOPENTANOATE 1 12C - Face and Neck (exc shave)

TRIDECYL STEARATE 1 01B - Baby Lotions, Oils, Powders, and Creams TRIDECYL STEARATE 1 02A - Bath Oils, Tablets, and Salts TRIDECYL STEARATE 3 05A - Hair Conditioner TRIDECYL STEARATE 3 05G - Tonics, Dressings, and Other Hair Grooming Aids TRIDECYL STEARATE 1 05I - Other Hair Preparations TRIDECYL STEARATE 5 07C - Foundations TRIDECYL STEARATE 10 07E - Lipstick TRIDECYL STEARATE 1 07F - Makeup Bases TRIDECYL STEARATE 1 07I - Other Makeup Preparations TRIDECYL STEARATE 3 11A - Aftershave Lotion TRIDECYL STEARATE 1 11E - Shaving Cream TRIDECYL STEARATE 2 11G - Other Shaving Preparation Products TRIDECYL STEARATE 8 12A - Cleansing TRIDECYL STEARATE 4 12C - Face and Neck (exc shave) TRIDECYL STEARATE 16 12D - Body and Hand (exc shave) TRIDECYL STEARATE 10 12F - Moisturizing TRIDECYL STEARATE 4 12G - Night TRIDECYL STEARATE 1 12H - Paste Masks (mud packs) TRIDECYL STEARATE 9 12J - Other Skin Care Preps TRIDECYL STEARATE 1 13C - Other Suntan Preparations

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Decyl Alcohol Clinical Irritation and Sensitization Tested in at a concentration of 3% in petrolatum, decyl alcohol produced no irritation in a 48 h closed-patch test in 25 human subjects.185

Methanol Absorption, Distribution, Metabolism, and Excretion Methanol is further metabolized to formaldehyde and then to formic acid. The CIR Expert Panel concluded that formic acid is safe where used in cosmetic formulations as a pH adjustor with a 64 ppm limit for the free acid.201 The main toxicological risks in humans are severe metabolic acidosis with increased anion gap, typically following oral exposure resulting in > 100 mg/L of formate in the urine.202 The acidosis and the formic acid metabolite are believed to play a central role in both the central nervous system toxicity and the ocular toxicity.A study to determine the formate levels that resulted from exposure of human volunteers to 200 ppm of methanol for 4 h was conducted. Human volunteers (n=27; age 20-55 y) were exposed to 200 ppm methanol (the Occupational Safety and Health Ad¬min¬istration [OSHA] Permissible Exposure Limit) for 4 h and to water vapor for 4 h in a double-blind, random study.203 Urine samples were collected at 0, 4 and 8 h and blood samples were collected from the subjects before they entered the cham¬ber, every 15 min for the first hour, every 30 min from the first to the third hour and at 4 h. Urine and serum samples were analyzed for formate (LOD 0.5 mg/L). Twenty-six of 27 enrolled subjects completed the study (11 females and 15 males). The researchers did not find any statistically significant differences in serum or urine formate levels between the two ex¬posure conditions at any time point. At the end of the 4 h methanol exposure, formate concentrations of 14.28 ± 8.90 and 7.14 ± 5.17 mg/L were measured in serum and urine, respectively. Under control conditions, formate concentrations of 12.68 ± 6.43 (p=0.38; n=26) and 6.64 ± 4.26 (p=0.59; n=25) mg/L were measured in serum and urine respectively. After 8 h (4 h of no exposure) the serum concentrations were not statistically different with 12.38 ± 6.53 mg/L under methanol exposure con¬di¬tions and 12.95 ± 8.01 (P=0.6; n=26) under control conditions. Urine formate concentrations after 8 h were 6.08 ± 3.49 and 5.64 ±3.70 mg/L (p=0.6; n=25) in exposed and control conditions, respectively, and were not statistically significantly different.182

Clinical Irritation and Sensitization Methyl Alcohol caused primary irritation to the skin; prolonged and repeated contact with Methyl Alcohol resulted in de¬fat¬ting and dermatitis. In one occupational study, 3.2% of 274 metalworkers with dermatitis had positive results to a patch test of 30% Methyl Alcohol. Typical allergic responses observed after contact with alcohols were eczematous eruption and wheal and flare at the exposure sites. Eczema and erythema were reported after the consumption of alcoholic beverages by persons sensitized to ethyl alcohol. Five percent Methyl Alcohol caused a slight positive (+) reaction in a closed patch test for allergic contact derma¬ti¬tis, and concentrations of 7% and 70% caused (+++) reactions.204

Clinical Assessment of Safety Clinical data show that Methyl Alcohol can cause severe metabolic acidosis, blindness, and death: toxicity was manifested earlier and at a lower dose compared to ethyl alcohol, but the comparative fatal dose was the same for both alcohols. All routes of expo¬sure were toxicologically equivalent, as the alcohol distributed readily and uniformly throughout all tissues and organs. Indivi¬dual susceptibilities to Methyl Alcohol varied, but typically, the ingestion of 80 to 150 ml of 80% Methyl Alcohol was fatal. Symp¬toms of Methyl Alcohol intoxication after ingestion were delayed for 12 to 18 hours; afterwards, the symptoms included head¬ache, anorexia, weakness, fatigue, leg cramps, and/or pain and vertigo. Severe gastrointestinal pain, nausea, vomiting, diarrhea, mania, failed vision, and convulsions could occur. Chronic exposure to Methyl Alcohol could cause edema, granular degen¬eration, and necrosis of heart muscle fibers, as well as fatty degeneration of the heart muscle; sudden cardiac failure was associated with Methyl Alcohol intoxication. The liver and kidneys often had parenchymatous degeneration, and the liver had focal necrosis and fatty infiltration. Severe acidosis was necessary for the

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development of blindness. Similar symptoms were observed after percutaneous or inhalation exposure to Methyl Alcohol.204

Propyl Alcohol Absorption, Distribution, Metabolism, and Excretion Rats (strain/sex/number not specified) were exposed via inhalation to 2,000 ppm (8360 mg/m3) for 90 min.205 Propyl acetate was rapidly hydrolyzed to propyl alcohol. During the 90 min exposure period, blood levels of propyl alcohol were between 2.6 and 7.7 fold greater than propyl acetate.182

Reproductive and Developmental Toxicity The effects of propyl alcohol on fertility were investigated by exposing male Sprague-Dawley rats (18/group) to 0, 3500 or 7000 ppm (0, 8.61 or 17.2 mg/L) propyl alcohol vapor via inhalation 7 h/day, 7days/week for 62 days, prior to mating with unexposed virgin females.206 Female Sprague-Dawley rats (15/group) were similarly exposed and mated with unexposed males. Following par¬turition, litters were culled to 4/sex and the pups fostered by unexposed dams. The pups were weaned on post natal day (PND) 25 and weighed on PND 7, 14, 21, 28 and 35. Male rats exposed to 7000 ppm exhibited a decrease in mating success with 2/16 producing a litter (1 male died as a result of a cage fight and 1 male did not mate). Mating success was not affected in 3500 ppm exposed males or in females. Six males from the 7000 ppm group were retained to determine if this effect was revers¬ible. All 6 males successfully mated 15 weeks after exposure. The authors reported that weight gain was not affected in 7000 ppm exposed females (data not shown), but feed intake was decreased in this treatment group. Crooked tails were observed in 2-3 offspring in 2 of 15 litters from the 7000 ppm maternally exposed group. No other effects on female fertility were reported. No significant differences resulted between offspring of the 7000 ppm group and controls on several behavioral toxicology mea¬sures including the Ascent test, Rotorod test, Open Field test, activity test, running wheel activity, avoidance conditioning, and oper¬ant conditioning. Activity measures were significantly different between offspring of the 3500 ppm exposure group and controls.182

Clinical Irritation and Sensitization A cumulative irritation study was conducted involving 20 male subjects, where the relative irritancy of free fatty acids of dif¬fer¬ent chain lengths was evaluated.191 Equimolar concentrations (0.5 M and 1.0 M) of even- and odd-numbered - straight chain saturat¬ed fatty acids were dissolved in propanol. Each Al-test® patch containing a fatty acid (0.5 M) was applied to the inter¬scap¬u¬lar area of 10 subjects, and, similarly, each fatty acid was applied at a higher concentration (1.0 M) to the remaining 10 subjects. A control patch containing propanol was also applied to each subject. Patches remained in place for 24 h and reactions were scored 30 minutes after patch removal. This procedure was repeated daily for a total of 10 applications. In both groups of 10 subjects, there were no reactions to propanol.\ In an irritation study, wherein 116 healthy male subjects (21 to 55 years old) were patch tested with pelargonic acid at concentrations of 5%, 10%, 20%, and 39.9% in propanol, a propanol-treated control patch was used.192 Dose response curves were developed. Patches (Al-test® discs) were saturated with 0.04 ml of a test solution and applied to the upper back for 48 h. Reac¬tions were scored at 48 h and 96 h post-application. There were no reactions to propanol. In an another irritation study, wherein 16 volunteers (10 females, 6 males; median age of 29.5 years) were patch tested (closed patches, Finn chambers) with 20% pelargonic acid in propanol (pH of 4.3), propanol was one of the controls used.207 Patches were applied to the anterolateral surface of both upper arms for 24 h. Reactions were scored at 24, 48, and 96 h post-application accord¬ing to the following scale: 0 (no reaction) to 3 (strong positive reaction: marked erythema, infiltration, possibly vesicles, bullae, pustules and/or pronounced crusting). There were no reactions to propanol. A skin irritation study was conducted using 42 healthy, non-atopic male volunteers (mean age = 34 years; skin types: II [20 subjects], III [17 subjects], and IV [5 subjects]).193 Pelargonic acid was patch-tested (Finn

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chambers, volar forearm) at the followi¬ng concentrations (in propanol): 40% (12 subjects), 60% (32 subjects), 70% (32 subjects), and 80% (28 subjects), and pro¬panol was used as a control. Each subject received between 3 and 10 patch tests. The patches remained in place for 48 h, and reac¬tions were scored 1 h later according to the following scale: - (no visible reaction) to 4+ (intense erythema with bullous forma¬tion). There were no reactions to propanol. In an irritation study, wherein 16 healthy subjects (ages not stated) were patch tested with pelargonic acid (20% in propanol), propanol was used as a control.194 Closed patches (Finn chambers) containing the test substance were applied to the anterolateral surface of both upper arms. The patches were removed at 24 h post- application and reactions were scored at 24 h and 96 h post-appli¬ca¬tion. There were no reactions to propanol. In study conducted to investigate a possible seasonal variation in the skin response to pelargonic acid during the winter and sum¬mer, propanol was used as a control.196 The study was conducted using 17 healthy volunteers (10 males, 7 females; mean age = 27 years). The test substance was applied (closed patch, Finn chamber) to each arm for 24 h. Reactions were scored at 30 min post-removal. Reactions were not observed at sites treated with propanol, water, or to which an empty chamber was applied.

Cetyl Alcohol Clinical Irritation and Sensitization A topical tolerance study involving an 11.5% Cetyl Alcohol cream base was conducted with 80 male subjects, ranging in age from 21 to 52 years and in weight from 120 to 220 pounds. The preparations were applied five times daily (every 3 hours) for 10 days. One subject had erythema, folliculitis, and pustule formation (forearm site).200 A formulation containing 6.0% Cetyl Alcohol was tested for its skin irritation potential in 20 subjects according to the protocol stated above. The product did not induce skin irritation. In another study, the skin irritation potential of a cream containing 6.0% Cetyl Alcohol was evaluated in 12 female subjects (18-60 years old). The total irritation score (all panelists) for the 21 applications was 418, indicating mild cumulative irritation.200 The skin irritation and sensitization potential of a product containing 8.4% Cetyl Alcohol was evaluated in 110 female subjects. Four¬teen days after scoring of the tenth application site, a challenge patch was applied to each subject and removed after 48 h; sites were scored after patch removal. The product did not induce primary irritation or sensitization.200 The sensitization potential of a cream containing 3.0% Cetearyl Alcohol was evaluated in 25 subjects (18- 25 years old). Follow¬ing a 10-day non-treatment period, occlusive challenge patches were applied to new sites and removed after 48 h. Sensitization reac¬tions were not observed in any of the subjects.200

Photosensitization The photosensitization potential of a lipstick product containing 4.0% Cetyl Alcohol was evaluated in 52 subjects. The experimental procedure was not stated. Photosensitization reactions were not noted in any of the subjects. In another study, a skin care preparation containing 1.0% Cetyl Alcohol did not induce photosensitization in the 407 subjects tested. The experimental procedure was not stated.200

Isopropyl Alcohol Absorption, Distribution, Metabolism, and Excretion Male rabbits (3/group; strain not specified) were treated by different routes of exposure to compare the absorption and metabolism of isopropyl alcohol.208 Groups 1 and 2 were treated via gavage with the equivalent of 2 and 4 ml/kg absolute isopropyl alcohol, respectively, as a 35% isopropanol/water solution. Groups 3 and 4 were treated via whole-body inhalation for 4 h (towels soaked with isopropyl alcohol were place in the inhalation chamber and replenished at ½ hour intervals to maintained a saturated environment; no exact concentration given), with Group 3 animals receiving an additional dermal exposure in the form of a towel soaked with 70% isopropyl

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alcohol applied to the animals’ chests and Group 4 animals having plastic barriers on their chests and towels prepared the same way as in Group 3 applied on top of the plastic barriers. The alcohol on the towels was replenished at half hour intervals throughout the duration of the experiment. Blood samples were taken at 0, 1, 2, 3 and 4 h. Samples were analyzed for isopropyl alcohol and the metabolite acetone. Following gavage exposure to 2 or 4 ml/kg, maximum blood levels of 147 and 282 mg/dl, respectively, of isopropyl alcohol were measured. Concentrations of acetone rose steadily over the 4 h period and were 74 and 73 mg/dl following exposure to 2 or 4 ml/kg, respectively. The authors stated that the maximum levels of isopropyl alcohol observed in this experiment, correlated with inebriation and near coma in the animals. Following inhalation and dermal exposure, the concentration of isopropyl alcohol in the blood continued to rise and was 112 mg/dl at 4 h while the concentration of acetone was 19 at 4 h. Inhalation exposure with a plastic barrier between the soaked towel and the chest resulted in isopropyl alcohol and acetone blood levels of <10 mg/dl. The researchers concluded that isopropyl alcohol is absorbed by the dermal route but that prolonged dermal exposure (i.e. repeated sponging or soaking for several hours) would be required to produce significant toxicity.

Subchronic Inhalation Toxicity Fischer 344 rats and CD-1 mice (10/sex/group) were exposed via inhalation to 0, 100, 500, 1500, or 5000 ppm (0, 246, 1230, 3690, or 12,300 mg/m3) isopropyl alcohol for 6 h/day, 5 days/wk for 13 weeks.209 Ataxia, narcosis, hypoactivity and the lack of a startle reflex were observed during exposure at 5000 ppm. Hypoactivity was observed in animals exposed to 1500 ppm iso¬propyl alcohol. At 13 weeks, no gross lesions were observed. Microscopic examination of control and 5000 ppm exposed ani¬mal tissues showed hyaline droplets within the kidneys of male rats only. The size and frequency of the droplets was increased in the treated group. The authors concluded that the NOAEL for this study was 500 ppm and the lowest-observable adverse effect level (LOAEL) was 1500 ppm based upon clinical signs and changes in hematology at 6 weeks. To evaluate the neurobehavioral effects of iso¬pro¬panol exposure, an additional 15 rats/sex were exposed (via inhalation) to 0, 500, 1500, or 5000 ppm (0, 1230, 3690, or 12,300 mg/m3) for 6 h/day, 5 days/wk for 13 weeks. Isopropyl alcohol did not pro¬duce any changes to the parameters of the functional observations battery which was conducted at 1, 2, 4, 9 and 13 weeks. Clin¬i¬cal signs observed in mice, during the exposure, included ataxia, narcosis, hypoactivity and lack of a startle reflex at 5000 ppm. Nar¬co¬sis, ataxia and hypoactivity were observed in animals exposed to 1500 ppm isopropyl alcohol. At 5000 ppm, increased body weight and increased rate of weight gain were observed in female mice. At 13 weeks, no gross lesions were observed and no treatment-related microscopic changes were observed. A 10% and 21% increase in relative liver weight was observed in female mice at 1500 and 5000 ppm, respectively. The authors concluded that the NOAEL for this study was 500 ppm and the LOAEL was 1500 ppm based on clinical signs and increased liver weights.

Ocular Irritation Isopropyl alcohol has been labeled a severe ocular irritant based on rabbit ocular irritation tests.210

Reproductive and Developmental Toxicity Female Sprague-Dawley rats (25/group) were exposed to 0, 400, 800, or 1200 mg/kg bw/day isopropyl alcohol via gavage on gestational days (GD) 6 through 15.211 Female New Zealand white rabbits (15/group) were exposed to 0, 120, 240, or 480 mg/kg bw/day isopropyl alcohol via gavage on GD 6 through 18. Animals were observed for body weight, clinical effects and feed consumption and the fetuses examined for body weight, sex and visceral and skeletal alterations at GD 20 for rats and GD 30 for rabbits. In rats, 2 dams died at the 1200 mg/kg bw dose and 1 dam died at the 800 mg/kg bw dose. Maternal gestational weight gain was reduced at the highest dose tested. No other effects were observed on maternal reproductive health. Fetal body weights at the two highest doses were decreased statistically. No evidence of teratogenicity was observed at any dose. In rabbits, four does died at the 480 mg/kg bw dose. Treatment related clinical signs of toxicity were observed at the 480 mg/kg bw dose and included, cyanosis, lethargy, labored respiration and diarrhea. No treatment related findings were observed at GD 30. Decreased feed consumption and maternal body weights, at 480 mg/kg bw, were statistically significant. No

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other effects were observed on maternal reproductive health. No evidence of teratogenicity was observed in the rabbits at any dose. The authors determined NOAELs for both maternal and developmental toxicity of 400 mg/kg bw, each, in rats and 240 and 480 mg/kg bw, respectively, in rabbits.

Carcinogenicity Fischer 344 rats and CD-1 mice (65/rats/sex/group; 55/mice/sex/group) were treated via inhalation with 0, 500, 2500, or 5000 ppm (0, 1230, 6150, or 12,300 mg/m3) isopropyl alcohol for 6 h/day, 5 days/wk for 104 weeks in rats and 78 weeks in mice.209 An additional 10/animals/sex/species were treated with these same concentrations of isopropyl alcohol for 6 h/day, 5 days/wk for 72 weeks in rats and 54 weeks in mice and underwent an interim evaluation. Another 10 mice/sex/group were treated according to the paradigm described above for 54 weeks and then allowed to recover before being killed at 78 weeks. Animals were observed and evaluated for body and organ weights, ophthalmology, and clinical and anatomic pathology. In rats, increased mortality due to chronic renal disease was observed at 5000 ppm (both sexes) and at 2500 ppm (males only). Hypoactivity and lack of startle reflex were observed in 2500 ppm treated rats and hypoactivity, lack of startle reflex and narcosis were observed in 5000 ppm treated rats. With the exception of the ataxia, the clinical signs were transient and ceased when the exposure ended. Increases in body weight, body weight gain, and liver weights were observed in 2500 and 5000 ppm treated rats. Chronic renal disease was exacerbated in rats treated with isopropyl alcohol. Male rats had a concentration related increase in absolute and relative testes weights. At the interim euthanasia (after 72 weeks) male rats treated with 5000 ppm had an increased frequency of testicular seminiferous tubule atrophy upon microscopic evaluation. At the terminal euthanasia (104 weeks), male rats had a concentration dependent increase in the incidence of interstitial (Leydig) cell adenomas of the testes at all administered doses. No other tumor types were increased in rats under these treatment conditions as compared to controls. In mice, no differences in mortality were observed between control and treated animals. Hypoactivity, lack of a startle reflex, narcosis, ataxia, and prostration were observed in 5000 ppm treated mice. Hypoactivity, lack of startle reflex and narcosis were observed in 2500 ppm treated mice. Increases in body weight, body weight gain, and liver weights were observed in 2500 and 5000 ppm treated mice. Male mice in all treatment groups had a decrease in relative testes weights, and female mice exposed to 5000 ppm isopropyl alcohol exhibited decreases in absolute and relative brain weights. At the terminal euthanasia (78 weeks) an increased incidence of minimal to mild renal tubular proteinosis was observed in males and females in all treatment groups. Male mice exposed to 2500 and 5000 ppm exhibited an increased incidence of dilation of the seminal vesicles. No neoplastic lesions were observed in male or female mice. The authors reported a NOAEL for toxic effects of 500 ppm for both rats and mice based on kidney and testicular effects. IARC (International Agency for Research on Cancer) has determined that isopropyl alcohol is not classifiable as to its carcinogenicity to humans (Group 3).182

Clinical Irritation and Sensitization According to unpublished data, a 80.74% spray concentrate caused did not exhibit any potential for dermal sensitization in 9 human subjects.197 According to unpublished HRIPT study on 109 test subjects, a 2.85% hair dye base formulation of isopropyl alcohol and a 1.95% isopropyl acetate caused no dermal sensitization in humans.198 The applicability of fluorescence confocal laser scanning microscopy for in situ imaging of irritant contact dermatitis caused by pel¬argonic acid using 12 healthy individuals (8 males, 4 males; 18 to 64 years old) was studied.199 Using Finn chambers (occlu¬sive patches), the flexor side of the right and left forearm was exposed to 60 µl of 10% (w/v) pelargonic acid in iso¬propa¬nol solu¬tion and isopropanol vehicle. Isopropanol was used as a control. The Finn chambers were removed at 24 h post-application and reac¬tions were scored according to the following scale: 0 (no visible reaction) to 4+ (intense erythema with bullous formation). Reac¬tions were not observed at sites treated with isopropanol.

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Hexyl Alcohol Ocular Irritation Undiluted hexyl alcohol has been labeled as highly irritating on rabbit ocular irritation tests.212

Dermal Sensitization In a maximization test using guinea pigs, hexyl alcohol was not a sensitizer at 1% in petrolatum.212

Caprylic Alcohol Dermal Irritation – Animals Caprylic alcohol applied full strength to intact or abraded rabbit skin produced a mild irritation.185

Clinical Irritation and Sensitization Tested in at a concentration of 2% in petrolatum, caprylic alcohol produced no irritation in a 48 h closed- patch test in 25 human subjects.185

Isobutyl Alcohol Subchronic Inhalation Toxicity Rats (10/sex/group) were exposed via inhalation to isobutyl alcohol vapor concentrations of approximately 0, 770, 3100, or 7700 mg/m3, for 6 h/day, 5 days/week, for 14 weeks.213 The functional observational battery was conducted along with end¬points of motor activity, neuropathology and scheduled-controlled operant behavior. A slight reduction in responsiveness to ex¬ter¬nal stimuli was observed in all treated groups during exposure. This effect resolved upon cessation of exposure to isobutyl alcohol.

Ethylhexyl Alcohol Absorption, Distribution, Metabolism, and Excretion In vitro dermal absorption rates were determined for ethylhexyl alcohol in rats and humans. In rats, the rate was 0.22 mg/cm2/h and in the human it was 0.038 mg/cm2/h.214 Accordingly, the human rate of ethylhexyl alcohol absorption was 5.78 times slower than in the rate in the rat.

Acute Dermal Toxicity In three different acute dermal toxicity studies on rabbits with ethylhexyl alcohol, the LD50 values reported were 2380, greater than 2600 and greater than 5000 mg/kg body weight.214

Repeated Dose Dermal Toxicity Rats (10) were dosed 2 ml/kg body weight/day (1600mg/kg/day) via single application on shaved backs.214 Absolute and relative thymus weights, liver granulomas, brochiectasis in the lung, renal tubular epithelial necroses, edematous heart and testes, and spermatogenesis, all decreased. Rats (10/sex) were dosed 0, 500, or 1000 mg/kg body weight/day (5 days occlusive, 2 days untreated, 4 days treated).214 500 and 1000 mg treated rats exhibited minimal exfoliation, decreased spleen weight and increased serum triglycerides in females.

Ocular Irritation Instillation of 20 µg of ethylhexyl alcohol into the conjunctival sac of rabbits caused moderately severe irritation of the cornea.212

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Dermal Irritation – Animals Ethylhexyl alcohol was applied under occlusion to the skin of 3 male rabbits for 4 hours and found to be irritating.212 In another study with rabbits, 0.5 ml of ethylhexyl alcohol was applied under occlusion on intact skin for 1, 2, 4, and 24 hours. Irritation was considered high, and effects seen after 7 days were not reversible.

Reproductive and Developmental Toxicity A group of female rats was exposed for 7 h per day to 850 mg/m3 of ethylhexyl alcohol on gestation days 1-19.212 Dams were sacrificed at day twenty. Ethylhexyl alcohol reduced maternal feed intake, but did not produce any malformations. The estrogenic activity of 2-ethylhexanoic acid was examined using an E-SCREEN assay using T47D human breast cancer cells.215 Weak estrogenic activity was observed. (Additional details were not provided.)

Genotoxicity In vitro, ethylhexyl alcohol was negative in a number of Ames assays, a liquid suspension assay, mouse lymphoma assay, and un¬scheduled DNA synthesis assay.118,139,140,143,151 In a 3H-thymidine assay, there was a dose-dependent inhibition of 3H-thymi¬dine into replicating DNA, with a dose-dependent increase in the ratio of acid-soluble DNA incorporated into the thymidine.140 The urine of rats dosed orally with 1000 mg/kg bw ethylhexyl alcohol was not mutagenic.150 In vivo, ethylhexyl alcohol was not geno¬toxic in a mouse micronucleus test or a transformation assay.151

Carcinogenicity B6C3F1 mice (50/sex/group) were administered 0, 50, 200, or 750 mg/kg body weight/day via gavage, 5 days/week for 18 months.214 At the 750 mg dose, weak hepatocellular carcinoma increased in females, body weight gain decreased and mortality increased. F344 rats (50/sex/group) were administered 0, 50, 150, or 500 mg/kg body weight/day via gavage, 5 days/week for 24 months. Rats dosed at 150 mg and greater were characterized with body weight gain decrease, lethargy and unkemptness. At 500 mg, mortality in females was at 52%.

Clinical Irritation and Sensitization Tested in at a concentration of 4% in petrolatum, ethylhexyl alcohol produced no irritation in a 48 h occlusive-patch test in 29 male volunteers.214 In a maximization study, ethylhexyl alcohol did not induce any sensitization reactions.

Isooctyl Alcohol Subchronic Oral Toxicity In a subchronic gavage toxicity study of a mixture of C7-9, branched alkyl alcohols in rats, a NOEL of 125 mg/kg bw/day and a lowest-observed effect level of 250 mg/kg bw/day were determined.118

Reproductive and Developmental Toxicity In an oral gavage developmental toxicity study of a mixture of C7-9, branched alkyl alcohols in rats, a maternal NOAEL of 500 mg/kg bw and a fetal NOAEL of 1000 mg/kg bw were reported.212

Genotoxicity A mixture of C7-9, branched alkyl alcohols were not mutagenic in in vitro bacterial and mammalian cell assays.212

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Carcinogenicity Ethylhexyl alcohol was not oncogenic in rats dosed, via gavage, with 0, 50, 150, or 500 mg/kg bw, in an aqueous vehicle with 0.005% Cremophor EL.212

Isononyl Alcohol Reproductive and Developmental Toxicity In an oral gavage developmental toxicity study of a mixture of C8-10, branched alkyl alcohols in rats, maternal and fetal NOAEL values were each reported to be 144 mg/kg bw. 212

Isodecyl Alcohol Reproductive and Developmental Toxicity In an oral gavage developmental toxicity study of a mixture of C9-11, branched alkyl alcohols in rats, a maternal NOAEL of 158 mg/kg bw and a fetal NOAEL of 790 mg/kg bw were reported. 212

Isostearyl Alcohol Clinical Irritation and Sensitization The skin irritation potential of lsostearyl Alcohol was evaluated in 19 male and female subjects (18-65 years old) at a con-centration of 25.0% in petrolatum. The test substance did not induce skin irritation in any of the subjects (Primary Irritation Index = 0.05). In three similar studies, three different lipstick products containing 25.0, 27.0, and 28.0% Isostearyl Alcohol, respectively, were tested according to the same protocol. The three products did not induce skin irritation.200 The irritation and sensitization potential of Isostearyl Alcohol (25% v/v in 95.0% isopropyl alcohol) was evaluated in 12 male subjects (21-60 years old). Challenge applications were made to original and adjacent sites 2 weeks after removal of the last induction patch. Three of 12 subjects had slight erythema during induction, and there was no evidence of sensitization.200 The sensitization potential of a pump spray antiperspirant containing 5.0% Isostearyl Alcohol was evaluated using 148 male and female subjects. The product was applied via an occlusive patch to the upper arm for a total of nine induction applications (3 times/week for 3 weeks). Each patch remained for 24 h, and sites were scored immediately before subsequent applications. During the challenge phase, a patch was applied to the induction site and to a new site on the opposite arm of each subject. Reactions were scored 48 and 96 h after application. Ten of the twelve subjects with reactions suggestive of sensitization were re-challenged with the product 2 months later. Patches remained for 24 h, and sites were scored at 48 and 96 h post-application. Six subjects had reactions during the re-challenge. Four of the six subjects were then tested with 5.0% Isostearyl Alcohol in solution with ethanol 6 weeks after scoring of the first rechallenge; all had positive responses. Negative responses were reported when the product (without lsostearyl Alcohol) and 100.0% ethanol each were tested. In a second study, the same product was applied to 60 male and female subjects (same protocol). Five of the subjects had positive responses after the first challenge. One of the five was re-challenged with 5.0% Isostearyl Alcohol in ethanol solution, and a positive reaction was observed.200

Isopropanol Comedogenicity An LDLo of 2-4 ml/kg of isopropyl alcohol has been reported in adults and 6 ml/kg (9 ml/kg 70% isopropyl alcohol) was reported to induce coma in children.