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A safety assessment of branched chain saturated alcohols when used as fragrance ingredients

Belsito, D.; Bickers, D.; Bruze, Magnus LU ; Calow, P.; Greim, H.; Hanifin, J. M.; Rogers, A. E.; Saurat, J. H.; Sipes, I. G. and Tagami, H. (2010) In Food and Chemical Toxicology 48. p.1-46
Abstract
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... (More)
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. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Branched chain saturated alcohols, Fragrance ingredients, Review, Safety
in
Food and Chemical Toxicology
volume
48
pages
1 - 46
publisher
Elsevier
external identifiers
  • wos:000280991200001
  • scopus:77955114583
ISSN
0278-6915
DOI
10.1016/j.fct.2010.05.046
language
English
LU publication?
yes
id
deeb1830-92c4-4a9c-ab3e-b152fb80d775 (old id 1673758)
date added to LUP
2010-09-23 08:04:44
date last changed
2018-10-03 12:02:22
@article{deeb1830-92c4-4a9c-ab3e-b152fb80d775,
  abstract     = {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.},
  author       = {Belsito, D. and Bickers, D. and Bruze, Magnus and Calow, P. and Greim, H. and Hanifin, J. M. and Rogers, A. E. and Saurat, J. H. and Sipes, I. G. and Tagami, H.},
  issn         = {0278-6915},
  keyword      = {Branched chain saturated alcohols,Fragrance ingredients,Review,Safety},
  language     = {eng},
  pages        = {1--46},
  publisher    = {Elsevier},
  series       = {Food and Chemical Toxicology},
  title        = {A safety assessment of branched chain saturated alcohols when used as fragrance ingredients},
  url          = {http://dx.doi.org/10.1016/j.fct.2010.05.046},
  volume       = {48},
  year         = {2010},
}