CIR Final Report on the Safety Assessment of Bisabolol

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International Journal of Toxicology

Volume 18, Supplement 3/November 1, 1999

Pages: 33 - 40

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.

Maurice

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Maurice O. Hevey

Convergent Cosmetics, Inc.

http://www.ConvergentCosmetics.com

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