5 Final Report on the Safety Assessment of Chloroxylenol

Abstract

Chloroxylenol is used in cosmetic products as an antimicrobial at concentrations up to 5.0 percent. It is absorbed through the human skin and gastrointestinal tract. Following oral ingestion by a human of a product formulated with Chloroxylenol, both free and conjugated Chloroxylenol were detected in the urine. Chloroxylenol at 100 percent concentration was a moderate irritant to the rabbit eye, whereas a 0.1 percent aqueous Chloroxylenol solution was a nonirritant to rabbit skin. Chloroxylenol was nonmutagenic in the Salmonella mutagenesis assay, both with and without metabolic activation. No carcinogenicity or adequate teratogenicity studies have been reported. In clinical studies, formulations containing up to 1.0 percent Chloroxylenol were nonsensitizing and essentially nonirritating to the skin. The incidence of skin sensitization among 1752 dermatitis patients exposed to 1.0 percent Chloroxylenol was less than 1.0 percent. On the basis of the available information included in this report, it is concluded that Chloroxylenol is safe as a cosmetic ingredient in the present practices of use.