A toxicologic and dermatologic assessment of cyclopentanones and cyclopentenones when used as fragrance ingredients

D. Belsito, D. Bickers, M. Bruze, P. Calow, M. L. Dagli, W. Dekant, A. D. Fryer, H. Greim, Y. Miyachi, J. H. Saurat, I. G. Sipes

    Research output: Contribution to journalReview articlepeer-review

    48 Scopus citations

    Abstract

    The cyclopentanone and cyclopentenone group of fragrance ingredients was critically evaluated for safety following a complete literature search. For high end users, calculated maximum dermal exposures vary from 0.002% to 15.16% in hydroalcoholic products; systemic exposures vary from 0.0003 to 0.7122. mg/kg/day. The cyclopentanones and cyclopentenones had a low order of acute toxicity and no significant toxicity in repeat dose studies. No mutagenic or genotoxic activity in bacteria and mammalian cell line assays was observed. Developmental toxicity was not observed. Minimal evidence of skin irritation in humans is associated with current levels of use. Eleven materials were tested undiluted for eye irritation; three were considered irritants. No phototoxic and photosensitization reactions were seen with nine materials tested. At concentrations higher than current reported use, 14 materials were non-sensitizing in HRIPT or maximization tests. 2-Hexylidene cyclopentanone, 2-heptylidenecyclopentan-1-one and 3-methyl-2-(pentyloxy)-2-cyclopenten-1-one are weak sensitizers and have IFRA Standards. Risk of sensitization to the cyclopentanones and cyclopentenones is generally small under current levels of use. The Panel is of the opinion that there are no safety concerns for the cyclopentanones and cyclopentenones at reported levels of use and exposure as fragrance ingredients.

    Original languageEnglish (US)
    Pages (from-to)S517-S556
    JournalFood and Chemical Toxicology
    Volume50
    Issue numberSUPPL.3
    DOIs
    StatePublished - Oct 2012

    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 Research Institute for Fragrance Materials, an independent group of experts who evaluate the safety of the fragrance materials.

    Keywords

    • Cyclopentanones
    • Cyclopentenones
    • Fragrance material
    • Group summary
    • Ketones
    • Review

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