Final Report on the Safety Assessment of Choleth-24

Abstract

Choleth-24 is the polyoxyethylene ether of the cholesterol fraction of lanolins, and is used in cosmetics as a surfactant, dispersant, stabilizer, and emulsifier at concentrations up to 5%. Acute animal studies have shown Choleth-24 to be slightly toxic when ingested, nonirritating to mildly irritating when applied by the Draize method to skin at concentrations of 0.5-100%, and practically nonirritating when instilled in the eyes of rabbits at concentrations up to 100%. Clinical studies have determined Choleth-24 to be only slightly irritating and nonsensitizing when applied to human skin in concentrations up to 50%. Choleth-24 at 0.5% concentration was neither phototoxic nor photoallergenic when tested in 201 subjects. It is concluded that Choleth-24 is safe for topical application to humans in the present practices of use and concentration.