Research Summary:
Enclosed is the Draft Report on the Safety Assessment of Polysilicone-11 as Used in Cosmetics (polysil122019rep). This ingredient is a crosslinked dimethylsiloxane, formed by the reaction of bis-vinyldimethicone and hydrogen dimethicone, and is reported to function as a film former in cosmetics.
Following an intensive search of information in the published scientific literature, online databases, and other sources on this ingredient, there was insufficient information found to justify the preparation of a formal Scientific Literature Review (SLR). Therefore, in July 2019, CIR issued a SLR Notice to Proceed (NTP) for Polysilicone-11 to alert interested parties that a safety assessment is being prepared and to request information in multiple areas, including:
- Chemistry information, including composition and structure, method of manufacture, and impurity data
- Toxicokinetics data relevant to routes of exposure expected with cosmetic use
- General toxicity data
- Developmental and reproductive toxicity data
- Genotoxicity data
- Carcinogenicity data
- Dermal irritation and sensitization data
- Inhalation toxicity data
- Any other relevant safety information that may be available
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