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

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

    Research output: Contribution to journalReviewResearchpeer-review

    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
    JournalFood and Chemical Toxicology
    Volume48
    Issue numberSuppl. 4
    Pages (from-to)S1-S46
    ISSN0278-6915
    DOIs
    Publication statusPublished - 2010

    Keywords

    • Safety
    • Fragrance ingredients
    • Branched chain saturated alcohols

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