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

D. Belsito, D. Bickers, M. Bruze, P. Calow, H. Greim, J. M. Hanifin, A. E. Rogers, J. H. Saurat, I. G. Sipes, H. Tagami

    Research output: Contribution to journalReview articlepeer-review

    35 Scopus citations

    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.

    Original languageEnglish (US)
    Pages (from-to)S1-S46
    JournalFood and Chemical Toxicology
    Volume48
    Issue numberSUPPL. 4
    DOIs
    StatePublished - Jul 2010

    Bibliographical note

    Funding Information:
    This research was supported by the Research Institute for Fragrance Materials, an independent research institute that is funded by the manufacturers of fragrances and consumer products containing fragrances. The authors are all members of the Expert Panel of the Research Institute for Fragrance Materials, an independent group of experts who evaluate the safety of fragrance materials.

    Keywords

    • Branched chain saturated alcohols
    • Fragrance ingredients
    • Review
    • Safety

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