Safety Assessment of Fluoropolymers as Used in Cosmetics Status: Draft Report for Panel Review Release Date: February 9, 2018 Panel Date: March 5-6, 2018 The 2018 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 Executive Director is Bart Heldreth, Ph.D. This report was prepared by Wilbur Johnson, Jr., M.S., Senior Scientific 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: Wilbur Johnson, Jr. Senior Scientific Analyst Date: February 9, 2018 Subject: Draft Report on Fluoropolymers A Scientific Literature Review (SLR) on Fluoropolymers was issued on January 8, 2018. The attached use concentration data (fluoro032018data1 and fluoro032018data2) that are included in this draft report were received from the Personal Care Products Council (Council) prior to issuance of the SLR. Data relating to the skin irritation and sensitization potential and ocular irritation potential of formulas containing PTFE (fluoro032018data3) and report comments (fluoro032018pcpc1) were received from the Council after the SLR was issued. These data are included in the draft report, and the Council’s comments have been addressed. Additionally, a memorandum with report comments (fluoro032018pcpc2) was received from the Cosmetic Ingredient Review (CIR) Science and Support Committee of the Council. This memorandum states that further justification for the current grouping of ingredients for review (generated by CIR staff) in this safety assessment is needed. Furthermore, the memorandum states that the appropriateness of using data on one ingredient to support the safety of other ingredients in the safety assessment is not clear and requires further discussion within the report, that is, if all of the other ingredients remain in a single report. These issues will need to be addressed by the Panel. Also included in this package for your review are the Draft Report (fluoro032018rep), the CIR report history (fluoro032018hist), Flow chart (fluoro032018flow), Literature search strategy (fluoro032018strat), Ingredient data profile (fluoro032018prof), and 2017 FDA VCRP data (fluoro032018FDA). No studies on PTFE, or other fluoropolymers that are being reviewed, relating to inhalation toxicity potential have been identified in the published literature. The National Toxicology Program (NTP) has evaluated the carcinogenicity of tetrafluoroethylene, the monomer that is used in the synthesis of PTFE, and the NTP’s conclusion is stated in the Carcinogenicity section of the safety assessment for the Panel’s consideration. After reviewing these documents, if the available data are deemed sufficient to make a determination of safety, the Panel should issue a Tentative Report with a safe as used, safe with qualifications, or unsafe conclusion. If the available data are insufficient, the Panel should issue an Insufficient Data Announcement (IDA), specifying the data needs therein. __________________________________________________________________________________________ 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 SAFETY ASSESSMENT FLOW CHART INGREDIENT/FAMILY _____ Fluoropolymers ______________________________________________ MEETING ___March 2018________________________________________________________________ Public Comment CIR Expert Panel Report Status Priority List INGREDIENT PRIORITY LIST SLR Jan 8, 2018 DRAFT REPORT Mar 2018 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 CIR History of: Fluoropolymers A Scientific Literature Review (SLR) on Fluoropolymers was issued on January 8, 2018. Draft Report, Teams/Panel: March 5-6, 2018 The draft report contains use concentration data on the fluoropolymers that were received from the Council. Skin irritation and sensitization data and ocular irritation data on formulas containing PTFE were also received, and these data are included in the draft report as well. Report comments that were received from the Council have been addressed. Comments relating to the need for further justification for the grouping of ingredients that are being reviewed in this safety assessment were received from the CIR Science and Support Committee of the Personal Care Products Council. Distributed for comment only -- do not cite or quote Data Profile for March 5th-6th, 2018 Panel – Wilbur Johnson Carcinogenicity OtherRelevant Enhancement Epidemiology Dermal ADME Acute Toxicity DART Dermal Ocular Clinical Case Sub Genotoxicity Penetration Penetration Short Penetration Irritation Sensitization Irritation Studies Reports Chronic Chronic Tox Toxicity Toxicity Studies Studies Dermal Dermal - Nail Chronic Chronic * - icity Term * Animal Animal Animal Animal Animal In Vitro Vivo In In Vitro In In Vitro Vivo In Animal Animal Human Animal vitro Animal In Dermal In Vitro Animal Animal Human In Vitro Animal Subcutaneous Human Human Human Human In Vitro Vivo In In Vitro In Vitro Vivo Vivo -Oral -Oral - -Oral -Oral - - /Human - - - Vivo /In - - - - - - - - - Inhalation Animal Inhalation Dermal Dermal Human Human Human Human Human Animal Oral Dermal Inhalation Animal /In /In PTFE X X X X X X X X X X X X Acrylates/Methoxy PEG-23 Methacrylate/Perfluorooctyl Ethyl Acrylate Copolymer Acrylates/Perfluorohexyleth- yl Methacrylate Copolymer Behenyl Methacrylate/Perfluorooctyl- ethyl Methacrylate Copolymer C6-14 Perfluoroalkylethyl Acrylate/HEMA Copolymer Hexafluoropropylene/Tetra- fluoroethylene Copolymer PEG-10 Acrylate/Perfluorohexylethyl Acrylate Copolymer Polychlorotrifluoroethylene X X X X X X X X X X Polyperfluoroethoxymethoxy Difluoroethyl PEG Diisostearate Polyperfluoroethoxymethoxy Difluoroethyl PEG Ether Polyfluoroethoxymethoxy Difluorohydroxyethyl Ether Polyperfluoroethoxymethoxy Difluoromethyl Ether Stearyl Methacrylate/Perfluorooctyl- ethyl Methacrylate Copolymer X = data Distributed for comment only -- do not cite or quote [Fluoropolymers – 11/9/17;1/18/18] Ingredient CAS # InfoBase SciFinder PubMed TOXNET FDA EU ECHA IUCLID SIDS HPVIS NICNAS NTIS NTP WHO FAO ECET Web -OC Polytetrafluoroethylene (PTFE) 9002-84-0 1/1 1489/59 15/7 3957/10 Yes No No 6/0 No No No No Yes No No No Report Report Acrylates/Methoxy PEG-23 1/1 0/0 0/0 0/0 No No No No No No No No No No No Methacrylate/Perfluorooctyl Report Ethyl Acrylate Copolymer Acrylates/Perfluorohexylethyl 1557087-30- 1/1 2/1 0/0 0/0 No No No No No No No No No No No No Methacrylate Copolymer 5 Report Behenyl 1/1 0/0 0/0 0/0 No No No No No No No No No No No No Methacrylate/Perfluorooctylethyl Report Methacrylate Copolymer C6-14 Perfluoroalkylethyl 1/1 1/0 0/0 0/0 No No No No No No No No No No No No Acrylate/HEMA Copolymer Report Hexafluoropropylene/Tetrafluor 25067-11-2 1/1 73/7 1/1 0/0 No No No. 1/0 No No No No No No No No oethylene Copolymer Report Report PEG-10 1/1 0/0 0/0 0/0 No No No No No No No No No No No No Acrylate/Perfluorohexylethyl Report Acrylate Copolymer Polychlorotrifluoroethylene 9002-83-9 1/1 66/18 34/7 10/5 No No No No No No No No No No No No Report Report Polyperfluoroethoxymethoxy 1/1 0/0 0/0 0/0 No No No No No No No No No No No No Difluoroethyl PEG Report Diisostearate Polyperfluoroethoxymethoxy 162492-15-1 1/1 1/0 0/0 0/0 No No No 1/0 No No No No No No No No Difluoroethyl PEG Ether Report Polyperfluoroethoxymethoxy 1/1 0/0 0/0 0/0 No No No No No No No No No No No No Difluoroethyl PEG Diisostearate Report Polyperfluoroethoxymethoxy 88645-29-8 1/1 2/0 0/0 0/0 No No No 1/0 No No No No No No No No Difluorohydroxyethyl Ether Report Stearyl 1/1 1/0 0/0 0/0 No No No No No No No No No No No No Methacrylate/Perfluorooctylethyl Report Methacrylate Copolymer Search Strategy [document search strategy used for SciFinder, PubMed, and Toxnet] [identify total # of hits /# hits that were useful or examined for usefulness] Distributed for comment only -- do not cite or quote LINKS InfoBase (self-reminder that this info has been accessed; not a public website) - http://www.personalcarecouncil.org/science-safety/line-infobase ScfFinder (usually a combined search for all ingredients in report; list # of this/# useful) - https://scifinder.cas.org/scifinder PubMed (usually a combined search for all ingredients in report; list # of this/# useful) - http://www.ncbi.nlm.nih.gov/pubmed Toxnet databases (usually a combined search for all ingredients in report; list # of this/# useful) – https://toxnet.nlm.nih.gov/ (includes Toxline; HSDB; ChemIDPlus; DAR; IRIS; CCRIS; CPDB; GENE-TOX) FDA databases – http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm (CFR); then, list of all databases: http://www.fda.gov/ForIndustry/FDABasicsforIndustry/ucm234631.htm; then, http://www.accessdata.fda.gov/scripts/fcn/fcnnavigation.cfm?rpt=eafuslisting&displayall=true (EAFUS); http://www.fda.gov/food/ingredientspackaginglabeling/gras/default.htm (GRAS); http://www.fda.gov/food/ingredientspackaginglabeling/gras/scogs/ucm2006852.htm