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Safety Assessment of Sorbitan Esters As Used in Cosmetics

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Safety Assessment of Sorbitan Esters As Used in Cosmetics Safety Assessment of Sorbitan Esters as Used in Cosmetics Status: Re-Review for Panel Review Release Date: August 18, 2014 Panel Meeting Date: September 8-9, 2014 The 2014 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 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 Monice M. Fiume, Assistant Director/Senior Scientific Analyst and Bart Heldreth, Ph.D., Chemist. © 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: Monice M. Fiume MMF Assistant Director/Senior Scientific Analyst Date: August 18, 2014 Subject: Safety Assessment of Sorbitan Esters as Used in Cosmetics Enclosed is the Re-Review of the Safety Assessment on Sorbitan Esters as Used in Cosmetics. (It is identified as sorbes092014rep_final for posting in the pdf document.) In 1985, the Panel determined that a group of seven sorbitan esters were safe as used in cosmetic ingredients. In 2002, the Panel reviewed the safety of an additional 10 sorbitan ester, and issued an addendum to that report, concluding that the sorbitan fatty acid esters were safe as used in cosmet- ic ingredients. (The complete list of ingredients can be found in the Introduction of the report.) The Panel is now being asked to consider whether a re-review of this ingredient group is appropriate. The Panel should first determine whether the new data serve to reaffirm the existing conclusion, or, if they present a reason to reassess the safety of these ingredients. Much of the new data included in this safety assessment was found on the European Chemicals Agency (ECHA) website; as a reminder, the website provides summaries of information gener- ated by industry, and it is those summary data that are included. Secondly, four additional sorbitan esters (sorbitan undecylenate, sorbitan sesquicaprylate, sorbitan palmate, and sorbitan theobroma grandiflorum seedate) are being suggested for addition to this family. If the Panel agrees that the data in the existing reports, as well as the new data presented in this re-review document, support the safety of these proposed ingredients, the Panel should re-open this assessment and add these ingredients, thereby creating a family of 21 sorbitan esters. All of the ingredients, including the four proposed “add-ons,” share an identical sorbitan structural core, and only vary in the number of fatty acid chains and the lengths of those chains. Concentration of use data were received from the Council and are included for your review (sorbes092014data). (Also included are updated VCRP data, sorbes092014FDA.) You will note that the frequency of use of these ingredients has increased, but the concentration of use has not. Additionally, the original 1985 and 2002 safety assessments are pro- vided (sorbes092014prev_1; sorbes092014prev_2, respectively). Several outcomes are possible based on Panel review of this re-review document: 1. The Panel determines that the new data do not support the existing conclusion, and the report is re-opened to address these concern; 2. The Panel determines that the new data support the existing conclusion, and new and existing data also support the safety of the proposed “add-ons;” the Panel should issue a Tentative Amended Report that includes the new ingredients; or 3. The Panel determines that the new data support the existing conclusion, but the proposed “add-ons” are not “no-brainers” and are not appropriate for inclusion in the report; the Panel should reaffirm the existing conclusion, and not re-open the report. __________________________________________________________________________________________ 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 Distributed for Comment Only -- Do Not Cite or Quote Sorbitan Esters – History 1985: The Panel concluded that sorbitans stearate, laurate, sesquioleate, oleate, tristearate, palmitate, and trioleate are safe as used in cosmetics. 2002: The Panel issued an addendum to the 1985 sorbitan esters report, and reviewed the safety of sorbitans caprylate, cocoate, diisostearate, dioleate, distearate, isostearate, olivate, sesquiisostearate, sesquistearate, and triisostearate. The Panel concluded sorbitan fatty acid esters are safe as used. September 8-9, 2014: initial Panel review of the re-review. In addition to the 17 sorbitan esters previously reviewed, the Panel is being asked to consider whether sorbitan undecylenate, sorbitan sesquicaprylate, sorbitan palmate, and sorbitan theobroma grandiflorum seedate should be included in the report. Unpublished concentration of use data were included in the document. Distributed for Comment Only -- Do Not Cite or Quote Sorbitan Esters – Sept 2014 – Monice Fiume – – – – . Rptd Rptd – Dose, Derm Dose, Animal Tox Acute, Oral Animal Tox, Inhal Acute, Animal Tox Rptd Use Reported Mfg of Method Dermal Penetration Animal Tox Dermal Acute, Animal Tox, Rptd Dose, Oral Human Ocular Irritation Mucous Irr Membrane Toxicokinetics Repro/Dev Tox Repro/Dev Genotox Carciniogenicity Photocarc Dermal Irr/Sens Phototoxicity Dose, Oral Animal Tox RptdInhal Dose, Sorbitan Esters - General * * Sorbitan Caprylate X * Sorbitan Undecylenate Sorbitan Laurate X* X* X * * X * X* * * Sorbitan Palmitate X* X* * X X X* * Sorbitan Isostearate X* X X* * Sorbitan Oleate X* * * * X* * * Sorbitan Stearate X* * X* * X* * X X* * X* * X* X Fatty Sorbitan Sesquiesters Sorbitan Sesquicaprylate X X X X Sorbitan Sesquiisostearate X* * * * Sorbitan Sesquioleate X* * X* * X X* X* X Sorbitan Sesquistearate Fatty Sorbitan Diesters Sorbitan Diisostearate Sorbitan Dioleate Sorbitan Distearate Fatty Sorbitan Triesters Sorbitan Triisostearate X* Sorbitan Trioleate X* * X * X * X* X X Sorbitan Tristearate X* * X X* * Mixed Chain Length Sorbitan Monoesters Sorbitan Cocoate Sorbitan Olivate X * Distributed for Comment Only -- Do Not Cite or Quote Sorbitan Esters – Sept 2014 – Monice Fiume – – – – . Rptd Rptd – Dose, Derm Dose, Animal Tox Acute, Oral Animal Tox, Inhal Acute, Animal Tox Rptd Use Reported Mfg of Method Dermal Penetration Animal Tox Dermal Acute, Animal Tox, Rptd Dose, Oral Human Ocular Irritation Mucous Irr Membrane Toxicokinetics Repro/Dev Tox Repro/Dev Genotox Carciniogenicity Photocarc Dermal Irr/Sens Phototoxicity Dose, Oral Animal Tox RptdInhal Dose, Sorbitan Palmate X Sorbitan Theobroma Grandiflorum Seedate *“X” indicates that new data were available in a category for the ingredient “*” indicates that existing data are summarized for the ingredient Distributed for Comment Only -- Do Not Cite or Quote SORBITAN ESTERS RR PubMed Search – July 10, 2014 Sorbitan AND (Caprylate OR Cocoate OR Diisostearate OR Dioleate OR Distearate OR Isostearate OR Laurate OR Oleate OR Olivate OR Palmate OR Palmitate OR Sesquicaprylate OR Sesquiisostearate OR Sesquioleate OR Sesquistearate OR Stearate OR (Theobroma AND Grandiflorum AND Seedate) OR Triisostearate OR Trioleate OR Tristearate OR Undecylenate) – 233 hits/23 useful Additional Data Searched ECHA HPV/SIDS CFR JECFA FDA – Inactive Drug Ingredients EU Distributed for Comment Only -- Do Not Cite or Quote Safety Assessment of Sorbitan Esters as Used in Cosmetics Status: Re-Review for Panel Review Release Date: August 18, 2014 Panel Meeting Date: September 8-9, 2014 The 2014 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 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 Monice M. Fiume, Assistant Director/Senior Scientific Analyst and Bart Heldreth, Ph.D., Chemist. © Cosmetic Ingredient Review 1620 L Street, NW, Suite 1200 ♢ Washington, DC 20036-4702 ♢ ph 202.331.0651 ♢ fax 202.331.0088 ♢ [email protected] Distributed for Comment Only -- Do Not Cite or Quote INTRODUCTION In 1985, the Cosmetic Ingredient Review (CIR) Expert Panel (Panel) published a safety assessment of seven sorbitan esters; based on the data presented in that assessment, the Panel concluded that sorbitan stearate, sorbitan laurate, sorbitan sesqui- oleate, sorbitan oleate, sorbitan tristearate, sorbitan palmitate, and sorbitan trioleate were safe as used in cosmetic ingredi- ents.1 In 2002, the Panel considered the safety of an additional 10 sorbitan fatty acid esters, and based on new data as well as data from the 1985 review, concluded that the sorbitan fatty acid esters were safe as used in cosmetic ingredients.2 The Panel is now being asked to consider a re-review of the safety of the sorbitan esters. In addition to the sorbitan esters reviewed in 1985 and in 2002, an additional four previously un-reviewed ingredients currently are being proposed for addi- tion to this group. Upon approval by the Panel that it is appropriate to combine the ingredients from the 1985 and 2002 reviews, and include the previously un-reviewed ingredients (indicated by bolded
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