TY - JOUR
T1 - A safety assessment of branched chain saturated alcohols when used as fragrance ingredients
AU - Belsito, D.
AU - Bickers, D.
AU - Bruze, Magnus
AU - Calow, P.
AU - Greim, H.
AU - Hanifin, J. M.
AU - Rogers, A. E.
AU - Saurat, J. H.
AU - Sipes, I. G.
AU - Tagami, H.
PY - 2010
Y1 - 2010
N2 - The Branched Chain Saturated Alcohol (BCSA) group of fragrance ingredients was evaluated for safety. In humans, no evidence of skin irritation was found at concentrations of 2-10%. Undiluted, 11 materials evaluated caused moderate to severe eye irritation. As current end product use levels are between 0.001% and 1.7%, eye irritation is not a concern. The materials have no or low sensitizing potential. For individuals who are already sensitized, an elicitation reaction is possible. Due to lack of UVA/UVB light-absorbing structures, and review of phototoxic/photoallergy data, the BCSA are not expected to elicit phototoxicity or photoallergy. The 15 materials tested have a low order of acute toxicity. Following repeated application, seven BCSA tested were of low systemic toxicity. Studies performed on eight BCSA and three metabolites show no in vivo or in vitro genotoxicity. A valid carcinogenicity study showed that 2-ethyl-1-hexanol is a weak inducer of liver tumors in female mice, however, the relevance of this effect and mode of action to humans is still a matter of debate. The Panel is of the opinion that there are no safety concerns regarding BCSA under the present levels of use and exposure. (C) 2010 Elsevier Ltd. All rights reserved.
AB - The Branched Chain Saturated Alcohol (BCSA) group of fragrance ingredients was evaluated for safety. In humans, no evidence of skin irritation was found at concentrations of 2-10%. Undiluted, 11 materials evaluated caused moderate to severe eye irritation. As current end product use levels are between 0.001% and 1.7%, eye irritation is not a concern. The materials have no or low sensitizing potential. For individuals who are already sensitized, an elicitation reaction is possible. Due to lack of UVA/UVB light-absorbing structures, and review of phototoxic/photoallergy data, the BCSA are not expected to elicit phototoxicity or photoallergy. The 15 materials tested have a low order of acute toxicity. Following repeated application, seven BCSA tested were of low systemic toxicity. Studies performed on eight BCSA and three metabolites show no in vivo or in vitro genotoxicity. A valid carcinogenicity study showed that 2-ethyl-1-hexanol is a weak inducer of liver tumors in female mice, however, the relevance of this effect and mode of action to humans is still a matter of debate. The Panel is of the opinion that there are no safety concerns regarding BCSA under the present levels of use and exposure. (C) 2010 Elsevier Ltd. All rights reserved.
KW - Branched chain saturated alcohols
KW - Fragrance ingredients
KW - Review
KW - Safety
U2 - 10.1016/j.fct.2010.05.046
DO - 10.1016/j.fct.2010.05.046
M3 - Review article
C2 - 20659630
SN - 0278-6915
VL - 48
SP - S1-S46
JO - Food and Chemical Toxicology
JF - Food and Chemical Toxicology
ER -