8 Final Report on the Safety Assessment of Drometrizole

Abstract

Drometrizole is used in cosmetics as an ultraviolet (UV) light absorber and stabilizer, primarily at concentrations below 0.1%. Drometrizole is appreciably absorbed and metabolized. Repeated oral administration of Drometrizole for 14 or 28 days caused a significant increase in relative liver weight but did not affect the body weight gain. Drometrizole was relatively nontoxic in acute oral and dermal studies and only moderately irritating after direct instillation into the rabbit eye. Drometrizole was not mutagenic in either the Ames test with Salmonella typhimurium or in the mouse bone marrow micronucleus test. In clinical studies, Drometrizole tested at 1% was nonirritating in a single insult patch test. Twice daily applications of Drometrizole for 8 weeks produced no irritation. Only two hypersensitivity reactions were observed in a separate clinical study involving 145 patients. Cosmetic products containing up to 1.0% Drometrizole produced no irritation, sensitization, photosensitization, or phototoxicity. It is concluded that a 90-day subchronic oral toxicity study and mutagenicity testing in two systems other than the Ames assay and the mouse bone marrow micronucleus test are needed before an adequate safety assessment can be made. On the basis of the available data included in the report, it cannot be concluded that Drometrizole is safe for use in cosmetic products until such time that the appropriate safety data have been obtained and evaluated.