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Amended Safety Assessment of Benzophenones As Used in Cosmetics

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Amended Safety Assessment of Benzophenones As Used in Cosmetics Amended Safety Assessment of Benzophenones as Used in Cosmetics Status: Draft Amended Report for Panel Review Release Date: August 21, 2020 Panel Date: September 14-15, 2020 The Expert Panel for Cosmetic Ingredient Safety members are: Chair, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V. Belsito, M.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; James G. Marks, Jr., M.D.; Lisa A. Peterson, Ph.D.; Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The Cosmetic Ingredient Review (CIR) Executive Director is Bart Heldreth, Ph.D. This report was prepared by Wilbur Johnson, Jr., M.S., Senior Scientific Analyst, CIR and Jinqiu Zhu, Ph.D., Toxicologist. © 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◊ Washington, DC 20036-4702 ◊ Ph 202.331.0651 ◊ fax 202.331.0088 ◊ [email protected] Distributed for Comment Only -- Do Not Cite or Quote Commitment & Credibility since 1976 Memorandum To: Expert Panel for Cosmetic Ingredient Safety Members and Liaisons From: Wilbur Johnson, Jr. Senior Scientific Analyst, CIR Date: August 21, 2020 Subject: Amended Safety Assessment of Benzophenones as Used in Cosmetics The Expert Panel for Cosmetic Ingredient Safety (Panel) first reviewed the safety of benzophenones in 1981. The Panel subsequently published a final report (in 1983) with a conclusion stating that Benzophenones-1, -3, -4, -5, -9, and -11 are safe for topical application to humans in the present practices of use and concentration in cosmetics. In the same year, the Panel published an addendum to the final report, having concluded that Benzophenones-2, -6, and -8 are not mutagenic or genotoxic and that the published conclusion on Benzophenones-1, -3, -4, -5, -9, and -11 is applicable to these 3 ingredients. In accordance with Cosmetic Ingredient Review (CIR) Procedures, because it had been at least 15 years since the safety assessment was published, the Panel considered whether the safety assessment of benzophenones should be reopened at the September 2001 Panel meeting. At the conclusion of their discussion, the Panel determined to not reopen the 1983 published safety assessment until results from National Toxicology Program (NTP) carcinogenicity studies on benzophenones were available. A re-review summary with this determination was published in 1985. Because an NTP oral carcinogenicity study on Benzophenone-3 was published earlier this year, the Panel is asked to determine whether the 1983 published safety assessment should be reopened to include these and other current safety test data, and to add Benzophenones-7, -10, and -12, along with any available safety test data on these 3 ingredients. These data are included in the attached Draft Amended Report (benzop092020rep) for the Panel’s review. This report also contains summaries of data from the published final report and addendum (indicated by italicized text), as well as studies dated 1983 forward. The published final report, addendum, and re-review summary (benzop092020orig1, benzop092020orig2, and benzop092020orig3, respectively) are included for your reference. Of the more recent data in the Draft Amended Report are 2020 ingredient use frequency data from FDA (benzop092020FDA). Also included in this package for your review are the report history (benzop092020hist), flow chart (benzop092020flow), literature search strategy (benzop092020strat), 2020 FDA VCRP data (benzop092020FDA), meeting minutes relating to the original reviews as well as the Panel’s decision on re-opening the safety assessment (benzop092020min), data from the Council’s 2020 use concentration survey on benzophenones (benzop092020data1), and the ingredient data profile (benzop092020prof). This profile identifies information from the original report as well as any new information that was identified since that original report was issued. After reviewing these documents, if the available data are deemed sufficient to make a determination of safety, the Panel should issue a Tentative Amended Report with a safe as used, safe with qualifications, or unsafe conclusion, and Discussion items should be identified. 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 Distributed for Comment Only -- Do Not Cite or Quote RE-REVIEW FLOW CHART INGREDIENT/FAMILY_____Benzophenones-1 through -12 ______ MEETING _______ September 2020_____________________________________________________ Public Comment CIR Expert Panel Re-Review Rpt Status New Data; or announce > 15 years OR request The Panel first reviewed several since last JACT 2(5): 35-77, 1983 benzophenones in 1983 (report and review JACT 2(5): 79-84, 1983 addendum). A re-review was considered IJT 24 (Suppl 1): 10S-18S, 2005 in 2002, but was not re-opened, awaiting the results of an on-going NTP study. The NTP study was published in 2020, and a Re-review to Panel draft amended report was prepared. PRIORITY LIST Sept 2020 Are new data cause to reopen? YES NO DRAFT AMENDED REPORT DAR Sept 2020 Are new ingredients appropriate for inclusion/re-open? Table Table IDA TAR Yes No IDA Notice IDA RE-REVIEW Admin Book DRAFT TENTATIVE SUMMARY AMENDED REPORT Draft TAR Table Table Tentative Amended Report Issue TAR Draft FAR DRAFT FINAL 60 day Public comment period AMENDED REPORT Table Table Different Conclusion Final Amended Issue PUBLISH Report FAR *If Draft Amended Report (DAR) is available, the Panel may choose to review; if not, CIR staff prepares DAR for Panel Review. Distributed for Comment Only -- Do Not Cite or Quote CIR History of: Benzophenones-1, -2, -3, -4, -5, -6, -7, -8, -9, -10, -11, and -12 Panel: June of 1981 The Panel agreed there were sufficient data to make a safety determination on Benzophenones-1, -3, -4, -5, -7, -9, - 10, -11, and -12. However, there was discussion of the need for additional mutagenicity testing on Benzophenones- 2, -6, and -8. It was suggested the report be reconsidered by the Panel after the additional testing is done by industry; however, if testing is not done, the report would have to be separated, and Benzophenones-2, -6, and -8 deleted from the recommendation. An insufficient data report would be issued for Benzophenones -2, -6, and -8. Tentative Report, Panel: November of 1981 The following conclusion was unanimously accepted: “On the basis of the available animal data and clinical human experience presented in this report, the Panel concludes that Benzophenone-1, -3, -4, -5, -9, and -11 are safe for topical application to humans in the present practices of use and concentration in cosmetics.” Benzophenones-7, -10, and -12 were deleted from the approved safety recommendation and from the title of the report since they are not used in cosmetics. However, data on Benzophenones-7, -10, and -12 were left in the report as useful information because they are chemically similar to the other Benzophenones. The Panel agreed that, subject to minor revisions, the document will be issued as a Tentative Report for a 90-day comment period. With regard to Benzophenones-2, -6, and -8, the Panel recommended an Insufficient Data Report. The Panel reviewed the available mutagenesis data on Benzophenones-1, -2, -3, -4, -5, -6, -7, -8, -9, -10, -11, and -12, and found that the available data on Benzophenones-2, -6, and -8 were equivocal. Additional mutagenic testing is required for these three ingredients in a mammalian system, with Benzophenone-1 to be included in the study as a control. It should be noted that the Panel published a final report on benzophenones with the following conclusion in 1983: On the basis of the available animal data and clinical human experience presented in this report, the Panel concludes that Benzophenones -1, -3, -4, -5, -9, and -11 are safe for topical application to humans in the present practices of use and concentration in cosmetics. Final Report Addendum, Panel: December of 1982 The Expert Panel evaluated the mutagenicity data submitted in response to the Insufficient Data Report of November 25, 1981 on Benzophenones-2, -6, and -8, and found them to be adequate for an assessment of safety. The following conclusion of the report was unanimously approved: “The Panel concludes that Benzophenones-2, - 6, and -8 are not mutagenic or genotoxic, and that the conclusion for the Final Report on the Safety Assessment of 1, -3, -4, -5, -9, and -11 which states 'on the basis of the available animal data and clinical human experience presented in this report, the Panel concludes that Benzophenone-1, -3, -4, -5, -9, and -11 are safe for topical application to humans in the present practices of use and concentration in cosmetics' is also applicable to these ingredients.” It should be noted that the Panel published an addendum to the final report (in 1983), having concluded that Benzophenones-2, -6, and -8 are not mutagenic or genotoxic and that the published conclusion on Benzophenones - 1, -3, -4, -5, -9, and -11 is applicable to these 3 ingredients. Re-review, Teams/Panel: September of 2001 The Panel determined to not reopen the 1983 published safety assessment until results from National Toxicology Program (NTP) carcinogenicity studies on Benzophenones are available. Distributed for Comment Only -- Do Not Cite or Quote Draft Amended Report, Teams/Panel: September
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