Final report on the safety assessment of Bisabolol

Abstract

Bisabolol is a naturally occuring unsaturated monocyclic terpene alcohol, the alpha form of which is used in a wide range of cosmetic formulations as a skin conditioning agent at low concentrations ranging from 0.001% in lipstick to 1% in underarm deodorants. Animal studies demonstrate that Bisabolol is well absorbed following dermal exposure and one study using cadaver skin demonstrated that Bisabolol can enhance the penetration of 5- fluorouracil. Bisabolol was relatively nontoxic in acute oral studies in rats, dogs, and monkeys. Short-term oral exposure using rats did produce inflammatory changes in several organs, and reduced body weight and increased liver weights relative to body weight in dogs. The no-observable-adverse- effect level in a 28-day dermal toxicity study using rats was 200 mg/kg/day. No evidence of sensitization or photosensitization was found. Bisabolol was negative in bacterial and mammalian genotoxicity tests, and it did not produce reproductive or developmental toxicity in rats. The results of oral and dermal toxicity, genotoxicity, reproductive/developmental toxicity, sensitization, and photosensitization studies show little toxicity at levels expected in cosmetic formulations. Formulators should be alert to the possibility that use of Bisabolol may increase the penetration of other components of a cosmetic formulation. Based on the available data it was concluded that Bisabolol is safe as used in cosmetic formulations.