2 Final Report on the Safety Assessment of Benzophenones-1, 3, 4, 5, 9, and 11

Abstract

Benzophenones-1 to 12 are substituted derivatives of 2-hydroxybenzophe-none. They are used as photostabilizers in cosmetics and have a photoprotective effect on the skin. When ingested and absorbed, Benzophenones were primarily conjugated and excreted in the urine. Benzophenones were practically nontoxic when chronically administered orally to rats, and Benzophenones-3 and 4 were nontoxic when applied to the skin of rabbits at doses of > 5 g/kg. Subchronic oral ingestion of Benzophenone-3 at 1 % was nontoxic to rats; however, another study showed Benzophenone-3 at 0.5% was toxic. Benzophenone-1 elicited toxic effects in rats at 0.6 g/kg. Benzophenones were nonirritating or mildly irritating to rabbit skin at concentrations of up to 100% and practically nonirritating to the eyes of rabbits. A subchronic skin irritation test indicated that Benzophenone-4 was capable of causing minimal irritation in rabbits at a concentration of 10%. Benzophenone-3 was reported to be nonsensitizing and nonphototoxic in guinea pigs and rabbits. Benzophenones-1, 3, 4, 5, and 9 were nonmutagenic both with and without metabolic activation in the Ames test. Skin irritation and sensitization in humans indicated that Benzophenones were mildly irritating and sensitizing at concentrations greater than those used in cosmetics. On the basis of the available animal data and clinical human experience, it is concluded that Benzophenone-1, 3, 4, 5, 9, and 11 are safe for topical application to humans in the present practices of use and concentration in cosmetics.