Safety Assessment of Saccharide Esters As Used in Cosmetics
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Safety Assessment of Saccharide Esters as Used in Cosmetics Status: Draft Report for Panel Review Release Date: May 13, 2016 Panel Meeting Date: June 6-7, 2016 The 2016 Cosmetic Ingredient Review Expert Panel members are: Chair, 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 C. 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 Lillian J. Gill, D.P.A. This safety assessment was prepared by Laura N. Scott, Scientific Writer/Analyst. © Cosmetic Ingredient Review 1620 L Street, NW, Suite 1200 ♢ Washington, DC 20036-4702 ♢ ph 202.331.0651 ♢ fax 202.331.0088 ♢ [email protected] Commitment & Credibility since 1976 Memorandum To: CIR Expert Panel Members and Liaisons From: Laura N. Scott Senior Scientific Writer Date: May 13, 2016 Subject: Draft Report of the Safety Assessment of Saccharide Esters as Used in Cosmetics Enclosed is the Draft Report of the Safety Assessment of Saccharide Esters as Used in Cosmetics (identified as SACEST062016rep in the PDF document). This is the first time the Panel is seeing this safety assessment of 41 synthetic cosmetic ingredients that are the end products of the esterification of simple saccharides with a carboxylic acid. The Scientific Literature Review was issued on March 22, 2016. The Panel has reviewed the following reports with related or constituent ingredients of the saccharide esters: in 2014, monosaccharides, disaccharides, and related ingredients (safe as used); in 2013, Decyl Glucoside and other alkyl glucosides, which differ from glucose ester only in the number of glucose equivalents (safe as used when formulated to be non-irritating); and multiple safety assessments of various saccharide ester constituent acids with safe as used conclusions (e.g., acetic acid, lauric acid, and stearic acid). Concentrations of use data were received from the Council and are included in this package (SACEST062016data_1). Sucrose Dipalmitate, Sucrose Palmitate/Stearate, and Sucrose Stearate-Palmitate Ester have not yet been included in a Council industry survey, but when that data become available it will be added to the report. Sucrose Palmitate/Stearate and Sucrose Stearate-Palmitate Ester are listed in the Definitions/Functions Table 2 on the same line because they have the same definition; for the ingredient count they are also considered to be the same ingredient. However, they are listed on separate lines in the Use Table because data was recited in the VCRP for each separately. Also included are VCRP data (SACEST062016FDA). Of the 41 saccharide esters presented in this safety assessment, 24 are reported to be used in a total of 970 cosmetic formulations; Sucrose Acetate Isobutyrate has the highest reported uses (274). Sucrose Polycottonseedate has the highest maximum reported concentration of use in lipstick up to 87.7%. Saccharide esters were reported to be used in cosmetic formulations indicating potential exposure to the eye area and mucous membranes, possible ingestion, as well as, use in baby products. Additionally, the CIR report history (SACEST062016hist), Process flow chart (SACEST062016flow), Literature search strategy (SACEST062016strat), and Ingredient Data profile (SACEST062016prof) are enclosed for the Panel’s review. The following unpublished data have been submitted: 1. Harrison Research Laboratories, Inc. (submitted in 2015): HRIPT (from 1999) of a lipstick topcoat containing 88% Sucrose Polycottonseedate (SACEST062016data_2). __________________________________________________________________________________________ 1620 L Street, NW Suite 1200, Washington, DC 20036 (Main) 202-331-0651 (Fax) 202-331-0088 (Email) [email protected] (Website) www.cir-safety.org Council comments on the SLR (SACEST062016pcpc) were received and have been addressed. [Note: In this Draft Report the in-text Table references are linked directly to the corresponding Table at the end of the document. In the Word version use “Ctrl + left click” on the in-text link and in the PDF version simply double (left) click on the in-text link to go directly to the Table.] If the data included in this report adequately address the safety of the saccharide esters, the Panel should be prepared to formulate a tentative conclusion, provide the rationale to be described in the Discussion, and issue a Tentative Report for public comment. If the data are not sufficient for making a determination of safety, then an Insufficient Data Announcement should be issued that provides a listing of the additional data that are needed. __________________________________________________________________________________________ 1620 L Street, NW Suite 1200, Washington, DC 20036 (Main) 202-331-0651 (Fax) 202-331-0088 (Email) [email protected] (Website) www.cir-safety.org Distributed for Comment Only -- Do Not Cite or Quote SAFETY ASSESSMENT FLOW CHART INGREDIENT/FAMILY _____Saccharide Esters____________________________________________ MEETING _____June 2016______________________________________________________________ Public Comment CIR Expert Panel Report Status Priority List INGREDIENT PRIORITY LIST SLR March 22, 2016 DRAFT REPORT June 2016 Draft Report 60 day public comment period Table Table IDA TR IDA Notice IDA DRAFT TENTATIVE REPORT Draft TR Table Table Issue TR Tentative Report Draft FR DRAFT FINAL REPORT 60 day Public comment period Table Table Different Conclusion Issue PUBLISH Final Report FR Distributed for Comment Only -- Do Not Cite or Quote Report History-Saccharide Esters March 22, 2016-The Saccharide Esters Scientific Literature Review was posted at www.cir-safety.org for public comment. June 6-7, 2016- Distributed for Comment Only -- Do Not Cite or Quote Saccharide Esters Data Profile for June 5-6, 2016. Writer – Laura Scott Penetration ADME Acute Short- DART Carcino- Dermal Dermal Ocular Enhancement Toxicity Term Chronic genicity Irr. Sen. Irr. Toxicity Tox Genotox Cosmetic Reported Available No Penetration Human VitroIn Animal Human VitroIn Animal Animal Human Animal Animal Animal Human Animal Animal In VitroIn In Vivo Animal Animal Human Animal Human Animal Safety Data - - - - - - - - - - - Oral Other Dermal Oral Oral Oral Oral Oral Dermal Oral & IV Oral Use Alkyl Fatty Acid Esters (single chain length) Glucose Pentaacetate N X Sucrose Octaacetate N X Trehalose Undecylenoate Y X Maltitol Laurate Y X Sucrose Laurate Y X X X X X X X X Sucrose Dilaurate Y X Sucrose Trilaurate Y X Sucrose Myristate Y X Raffinose Myristate N X Sucrose Palmitate Y X X X X X Sucrose Dipalmitate Y X Raffinose Isostearate N X Sucrose Hexapalmitate N X Sucrose Stearate Y X X X X X Sucrose Oleate N X Trehalose Isostearate Esters Y X Raffinose Oleate N X Sucrose Distearate Y X Sucrose Tristearate Y X Sucrose N X Tetrahydroxystearate Sucrose N X Pentahydroxystearate Sucrose Polybehenate Y X X Sucrose Tribehenate N X Sucrose Pentaerucate N X Sucrose Hexaerucate N X Alkyl Fatty Acid Esters (mixed chain lengths) Sucrose Acetate Isobutyrate Y X X X X X X X X X X X X X X X X Xylityl Sesquicaprylate N X Sucrose Polylaurate Y X Sucrose Polystearate Y X Sucrose Polyoleate Y X Sucrose Polylinoleate N X Distributed for Comment Only -- Do Not Cite or Quote Saccharide Esters Data Profile for June 5-6, 2016. Writer – Laura Scott Penetration ADME Acute Short- DART Carcino- Dermal Dermal Ocular Enhancement Toxicity Term Chronic genicity Irr. Sen. Irr. Toxicity Tox Genotox Cosmetic Reported Available No Penetration Human VitroIn Animal Human VitroIn Animal Animal Human Animal Animal Animal Human Animal Animal In VitroIn In Vivo Animal Animal Human Animal Human Animal Safety Data - - - - - - - - - - - Oral Other Dermal Oral Oral Oral Oral Oral Dermal Oral & IV Oral Use Sucrose Tetraisostearate Y X Sucrose Acetate/ Stearate Y X Sucrose Tetrastearate Triacetate Y X Sucrose Palmitate/ Stearate Y X Sucrose Palmitate-Stearate Y X Ester Sucrose Polysoyate Y X Sucrose Hexaoleate/ Y X Hexapalmitate/ Hexastearate Sucrose Cocoate Y X Sucrose Polycottonseedate Y X X Non-Alkyl Esters Sucrose Benzoate Y X Sucrose Disinapate N X Distributed for Comment Only -- Do Not Cite or Quote Ingredient Cas No. Prev in NTIS FDA/ NTP TOXNET WHO ECHA HPVIS/ OECD/ EU NICNAS Web Rev Use CFR EPA SIDS Glucose Pentaacetate 3891-59-6, 604-68-2 - No X X - X - - - - X Listed, no X further info Maltitol Laurate 75765-49-0 2008 Yes - - - - - - - - - - X Raffinose Isostearate 1032182-34-5 - No - - - - - - - - - - X Raffinose Myristate 91433-10-2 - No - - - - - - - - X - X Raffinose Oleate 96352-58-8 - No - - - X - - - - X - X Sucrose Acetate 126-13-6 Isobutyrate - - - Tier I - Yes X X X X X X Cosmetic, X no further info Sucrose Acetate/ 52439-69-7 Stearate - Yes - - - X - - - - X - X Sucrose Benzoate 12738-64-6 - Yes X X - - - - - - X Listed, no X further info Sucrose Cocoate 91031-88-8 - Yes - X - - - - - - X Listed, no X further info Sucrose Dilaurate 25915-57-5 - Yes - X - X - - - - X - X Sucrose Dipalmitate* 25637972 - Yes X Sucrose Disinapate N/A - No - - - - - - - - - - X Sucrose Distearate 27195-16-0 - Yes - X - X - - - - X Listed, no X further info Sucrose Hexaerucate N/A - No - X - - - - - - - - X Distributed for Comment Only -- Do Not Cite or Quote Ingredient Cas No. Prev in NTIS FDA/ NTP TOXNET WHO ECHA HPVIS/ OECD/ EU NICNAS Web Rev Use CFR EPA SIDS Sucrose Hexaoleate/ N/A Hexapalmitate/ - Yes - X - - - - - - - - X Hexastearate Sucrose 29130-29-8 Hexapalmitate - No - X - X - - - - - - X Sucrose Laurate 25339-99-5,