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Safety Assessment of Alkoxyl Alkyl Silanes As Used in Cosmetics

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Safety Assessment of Alkoxyl Alkyl Silanes As Used in Cosmetics Safety Assessment of Alkoxyl Alkyl Silanes as Used in Cosmetics Status: Draft Final Report for Panel Review Release Date: November 11, 2016 Panel Meeting Date: December 5-6, 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 report was prepared by Lillian C. Becker, Scientific Analyst/Writer. © 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 and Liaisons From: Lillian C. Becker, M.S. Scientific Analyst and Writer Date: November 11, 2016 Subject: Safety Assessment of Alkoxyl Alkyl Silanes as Used in Cosmetics Attached is the draft final report of Alkoxyl Alkyl Silanes as used in cosmetics. [alalsi122016Rep] These four ingredients are grouped because they are structurally related as silanes bearing both simple alkyl and simple alkoxyl groups. These ingredients function as binders, skin-conditioning agents – miscellaneous, and skin-conditioning agents – emollient. In June 2016, the Panel issued a tentative report with the conclusion that these ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment. The Panel discussed the use of these ingredients as surface modifiers, the presence of residual starting materials (e.g., disilazane), and the use of inference (read- across) in assessing safety. No new data were submitted. The Wave 2 data from June have been incorporated into the report. Council comments have been addressed. [alalsi122016PCPC_1,2] The Panel should carefully review the Abstract, Discussion, and Conclusion of this report and issue a final 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 SAFETY ASSESSMENT FLOW CHART INGREDIENT/FAMILY ____Alkoxy Alkyl Silanes__________________________________________ MEETING _____Dec 2016______________________________________________________________ Public Comment CIR Expert Panel Report Status Priority List INGREDIENT PRIORITY LIST SLR January 19, 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 Tentative Report Issue TR June 13, 2016 Draft FR DRAFT FINAL REPORT Dec 2016 60 day Public comment period Table Table Different Conclusion Issue PUBLISH Final Report FR Distributed for comment only -- do not cite or quote History – Alkoxy Alkyl Silanes June, 2015 – Added to the Priority List. January, 2016 – SLR posted. June, 2016 – Panel examined the draft report. The Panel issued a Tentative Report with a conclusion of safe as used. The Panel discussed the use of these ingredients as surface modifiers, the presence of residual starting materials (e.g., disilazane), and inference (read-across). December, 2016 – The Panel is to examine the report, especially the Abstract, Discussion, and Conclusion. The Panel should issue a Final Report. Distributed for comment only -- do not cite or quote Alkoxy Alkyl Silanes Data Profile for September, 2016. Writer – Lill Becker Acute Repeated ADME toxicity dose toxicity Irritation Sensitization Penetration Dermal Log K Use Oral Dermal Inhale Oral Dermal Ocular Ocular In Vitro Dermal DermalHuman Dermal In Vitro Animal Human VitroIn Repro/Devel Genotoxicity Carcinogenicity Phototoxicity Inhale ow Animal Animal Bis-Stearoxydimethylsilane X X X X X X X X Stearoxytrimethylsilane X Triethoxycaprylylsilane X X X X X X X X X X Trimethoxycaprylylsilane X X X X X X X Triethoxycaprylylsilane-coated X titanium oxide particles Triethoxycaprylylsilane-coated X zinc oxide particles Triethoxycaprylylsilane-coated X X zinc oxide Distributed for comment only -- do not cite or quote Search Strategy – Alkoxyl Alkyl Silanes SciFinder Group Links: Compounds searched by identifiers (text and structure): 29043-70-7 – 5 hits. 0 useful. 18748-98-6 – 79 hits. Filtered for adversed effects/toxicity, biological studies, properties, and additional related refs - 56 hits. Removed Patents – 8 hits, 0 useful. 3069-40-7 – 1163 hits. Filtered for adversed effects/toxicity, biological studies, properties, and additional related refs - 189 hits. Removed patents – 107 hits, 1 useful. 2943-75-1 – 2115 hits. Filtered for adversed effects/toxicity, biological studies, properties, and additional related refs - 532 hits. Removed patents – 180 hits, 2 useful. References from text and structures searches: 3037 hits. Removed patents – 1023 hits. English – 922 hits. Toxicity – 17 hits, (same 3 useful). Irritation – 3 hits, 1 useful. Sensitization – 61 hits, 0 useful. Genotoxicity – 0 hits. Reproduction – 17 hits, 0 useful. How toxic is Bis-Stearoxydimethylsilane 29043-70-7 – 5 hits for “stearoxydemthylsilane or 29043-70-7, 0 useful. How toxic is Stearoxytrimethylsilane 18748-98-6 – not useful How toxic is Triethoxycaprylylsilane 2943-75-1 – 1 hit, retrieved. How toxic is Stearoxytrimethylsilane 18748-98-6 – not useful How toxic is Trimethoxycaprylylsilane 3069-40-7 – not useful Cosing – No restrictions, no opionions. HPVIS – no hits. ECHA - Bis-Stearoxydimethylsilane 29043-70-7 – no hits; Stearoxytrimethylsilane 18748-98-6 – hits; Triethoxycaprylylsilane 2943-75-1 – Data available; Trimethoxycaprylylsilane 3069-40-7 Data available. The same data sets were in both ECHA profiles. PUBMED – ingredient names and tox* - 2 hits, already had 1, acquired the other. CAS no. and tox* - 0 hits Distributed for comment only -- do not cite or quote Panel Transcripts – Alkoxyl Alkyl Silanes June, 2016 Dr. Belsito’s Team DR. BELSITO: So alkoxy alkyl silanes, that is under alkoxyl silanes. So this is the first time we're looking at these four ingredients. They're binder, skin conditioning agents and emollients. They're used in 413 leave-ons and therefore, I guess, for rinse-offs. And use concentrations are up to 2.6 percent in suntan products. And then, it goes on to say that one ingredient, trimethoxycaprylylsilane is a surface modifier. I'm not sure why that's important but I guess does that mean that you think it should go back in other report with the polysilicones? MS. BECKER: No, it's just the -- DR. BELSITO: It's just that it's a new use that the Dictionary has incorporated? MS. BECKER: No, it's a use that the last time was a controversy because of the difference between it actually being a surface modifier and not being a surface modifier where this one it's not a problem. And I just wanted to make sure you didn't conflate the two. DR. BELSITO: Right. DR. SNYDER: Only a surface modifier? MS. BECKER: No. DR. BELSITO: No, no. MS. BECKER: It can be used as both with -- DR. BELSITO: But the others we had data only on surface modification of zinc particles and so that we approved it for that and said if it was used for other uses that were then in the Dictionary, it would -- we would need to reconsider. So what Lillian is saying here one of these is a surface modification use and that's a new cosmetic definition that the INCI dictionary included, is that right? MS. BECKER: No, no. DR. BELSITO: So surface modification existed as a function in the prior Dictionary? DR. HELDRETH: Yeah but typically surface modifier means something a little bit different -- DR. BELSITO: Right. DR. HELDRETH: -- than this. It wasn't -- DR. BELSITO: Coating bead. DR. HELDRETH: -- a coata [coated?] particle. DR. BELSITO: Right. DR. HELDRETH: Now in this case these are different from those polymers we were looking at before because these are not polymers. DR. BELSITO: Right. DR. HELDRETH: The polysilicones we looked at before in situ the monomers were preliminarized [polymerized?] around those particles. This is seriously just a coating of the small molecules onto the metal particles. DR. BELSITO: Okay. DR. HELDRETH: But there is no polymerization involved. DR. BELSITO: So Dan, you're happy with this grouping? DR. LIEBLER: Yeah, I didn't have any issues with it. DR. BELSITO: Okay. We don't -- the highest concentration of use is for the tricaprylyl at two percent. And we don't have sensitization at that level. I'm not -- we have the triethoxycaprylylsilane and an animal study that I really couldn't follow the dilutions on on page 16. It says under the sensitization protocol so you had a product that had percent the stearoxydimethylsilane. And then, it says 7.5 percent Bis-stearoxymethylsilane. Is that 7.5 percent of a product that originally had 75 percent or is that 7.5 of the actual ingredient? MS. BECKER: I haven't found where you are yet. Can you tell me again, please? DR. BELSITO: PDF 16 the only study under sensitization. I'm just trying to clear a two percent level for an unrelated product because the highest level of use, because otherwise I can go safe when formulated to be non-irritating but I don't have sensitization data and I'm just trying to figure out where this level is in the one sensitization study we have because it was very confusing to me. The animals were challenged with the test substance. It says 50 percent 37.5 percent. So I'm assuming that and I don't follow that if the material is 75 percent Bis-stearoxy. I can't figure out the math here. Distributed for comment only -- do not cite or quote MS. BECKER: Okay. The product had 75 percent of the ingredient and they put 10 percent on it so that's 7.5 percent -- DR. BELSITO: Okay. MS. BECKER: -- of the challenge.
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