9 Final Report on the Safety Assessment of Phenoxyethanol

Abstract

Phenoxyethanol is an aromatic ether which is used in cosmetics as a preservative at concentrations below 1% and as a fixative for perfumes. According to the classification scheme of Hodge and Sterner,(1) Phenoxyethanol is practically nontoxic when administered orally or dermally to rats. In a subchronic oral toxicity study in rats of Phenoxyethanol, signs of toxicity included reduced body weights and an impaired ability to utilize feed. Increased liver, kidney, and thyroid weights were noted at necropsy in surviving rats. Undiluted Phenoxyethanol was a strong eye irritant, but was nonirritating when tested at 2.2%. Phenoxyethanol at 2.0% was a slight irritant to rabbit skin, but was neither an irritant nor sensitizer to guinea pig skin. In dermal treatment studies, Phenoxyethanol was neither teratogenic, embryotoxic, or fetotoxic at doses which were maternally toxic. Phenoxyethanol was nonmutagenic in the Ames test, with and without metabolic activition, and in the mouse micronucleus test. In clinical studies, Phenoxyethanol was neither a primary irritant nor sensitizer. Phenoxyethanol was not phototoxic in clinical studies. It is concluded that Phenoxyethanol is safe as a cosmetic ingredient in the present practices of use and concentration.