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 mdkg/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 formulafions. 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 formulafions.

Antifeedant effects of common terpenes from Mediterranean aromatic plants on Leptinotarsa decemlineata

“…However, the antifeedant activity (EC 50 ) of α-bisabolol was around 10 times stronger than that of (+)-terpinen-4-ol. In addition, the low toxicity of (-)-α-bisabolol to humans has been certified by the Food and Drug Administration (FDA, 2015) who has granted this compound with Generally Regarded As Safe (GRAS) and by the Cosmetic Ingredient Review (CIR) Expert Panel (Andersen, 1999). Consequently, α-bisabolol is the best option to develop natural antifeedant formulations against L. decemlineata on the basis of the high antifeedant and low phytotoxic activities of this terpene.…”

Detection of transgene expression using hyperpolarized 13C urea and diffusion‐weighted magnetic resonance spectroscopy

“…Hyperpolarized [ 13 C]urea has been used previously as a perfusion marker . Urea, which is produced in the liver and is responsible for nitrogen excretion via the kidneys, is highly soluble in water, metabolically inert in mammalian cells and thus nontoxic, even at high concentrations . Urea is transported across the plasma membrane by a family of urea transporters (also known as Kidd antigens), which are encoded by at least two genes in mammals : the UTA gene (or SLC14A2 ), which has up to five splice variants, and the UTB gene ( SLC14A1/UT3 ), which is spliced into a single transcript.…”

Anti-Ulcer Activity of Essential Oil Constituents

“…Bip., and other plants [127]. The oral acute toxicity (LD 50 ) of (‒)-α-bisabolol in mice was 5.1 mL/kg body weight and 14.9 mL/kg for ras [128]. From this data it is possible to conclude that the bisabolol is safe.…”