Final Report on the Safety Assessment of Dimethicone Copolyol

Abstract

Dimethicone Copolyols are chemically and physically inert ingredients used in cosmetics in a concentration range of less than or equal to 0.1-10%. This compound is, at most, slightly toxic to the rat when administered orally or dermally in a single dose. Copolyols were not primary skin or ocular irritants in the rabbit and gave no evidence of subchronic oral toxicity when fed to rats. Clinical studies showed that these Copolyols are neither primary skin irritants nor sensitizers when tested at a 100% concentration. On the basis of the available information presented in this report, it is concluded that Dimethicone Copolyol is safe as a cosmetic ingredient in the present practices of use and concentration.