Final Report on the Safety Assessment of p-Chloro-m-Cresol

Abstract

p-Chloro-m-Cresol is a substituted phenol that functions as a cosmetic biocide preservative in skin care and suntan cosmetic formulations. While p-Chloro-m-Cresol is approved for preservative use by the European Union at concentrations of up to 0.2%, it can be used at other concentrations when not intended as a preservative, and it is prohibited from use in products intended to contact mucous membranes. p-Chloro-m-Cresol is approved for use as an indirect food additive in the United States. Acute, short-term, and subchronic tests in animals indicate no dose-related toxicity other than reduced body weight gain. A chronic feeding study in rats identified kidney damage in high-dose males and an increase in pituitary adenomas in mid- and high-dose females. No evidence of mutagenicity was seen in Ames tests, but there was an increase in SOS-DNA repair synthesis in Escherichia coli. A solution of p-Chloro-m-Cresol at concentrations as low as 0.05% produced ocular irritation in rabbits. Some evidence of dermal irritation and sensitization was found in animal studies. In clinical studies, 2%o p-Chloro-m-Cresol seems to be a skin irritant. Predictive patch tests using 5% p-Chloro-m-Cresol as the challenge were negative, but provocative patch tests yielded positive responses in a few individuals. Other data pertinent to the safety assessment of thisingredient are not available, including the concentration of use in cosmetics, UV absorption data (photosensitization data also are needed if theingredient absorbs in the UVA or UVB region), dermal developmental toxicity data and a mutagenicity study using a mammalian system (a 2-year dermal carcinogenicity study is also needed if the mutagenesis study is positive). Based on the presently available data, the safety of thisingredient in cosmetic formulations cannot be supported.