A toxicological and dermatological assessment of macrocyclic lactone and lactide derivatives when used as fragrance ingredients

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

    Research output: Contribution to journalReview article

    21 Citations (Scopus)

    Abstract

    The Macrocyclic Lactone and Lactide derivative (ML) group of fragrance ingredients was critically evaluated for safety following a complete literature search. For high end users, calculated maximum dermal exposures vary from 0.47% to 11.15%; systemic exposures vary from 0.0008 to 0.25. mg/kg/day. The MLs had low acute toxicity and no significant toxicity in repeat dose oral ordermal toxicity studies. Effects on blood biochemistry were reversible after 2. weeks of no treatment. No mutagenic or genotoxic activity in bacteria and mammalian cell line assays was observed. Reproductive and developmental toxicity was not observed. Human dermatological studies show MLs are generally not irritating after one application. Minor irritation was observed in a few individuals following multiple applications. At rates consistent with reported levels for current human exposure, no phototoxicity or photosensitization was observed. In animal studies, the MLs are not sensitizers at lower exposures from consumer products. Eleven ML materials were evaluated for human sensitization. Of these, only ethylene brassylate showed evidence of sensitization in 2/27 studies (sensitization frequency 4/2059 total). Based on these findings, the Panel is of the opinion that there are no safety concerns for the MLs at reported levels of use and exposure as fragrance ingredients.

    Original languageEnglish (US)
    JournalFood and Chemical Toxicology
    Volume49
    Issue numberSUPPL. 2
    DOIs
    StatePublished - Dec 1 2011

    Fingerprint

    Fragrances
    Lactones
    lactones
    Toxicology
    Toxicity
    ingredients
    chemical derivatives
    odors
    Derivatives
    dermal exposure
    reproductive toxicology
    developmental toxicity
    phototoxicity
    Phototoxic Dermatitis
    drug toxicity
    Photosensitivity Disorders
    Safety
    blood chemistry
    acute toxicity
    toxicity testing

    Keywords

    • Fragrance
    • Macrocylic lactide
    • Macrocylic lactone
    • Review
    • Safety

    Cite this

    A toxicological and dermatological assessment of macrocyclic lactone and lactide derivatives when used as fragrance ingredients. / Belsito, D.; Bickers, D.; Bruze, M.; Calow, P.; Dagli, M. L.; Fryer, A. D.; Greim, H.; Miyachi, Y.; Saurat, J. H.; Sipes, I. G.

    In: Food and Chemical Toxicology, Vol. 49, No. SUPPL. 2, 01.12.2011.

    Research output: Contribution to journalReview article

    Belsito, D. ; Bickers, D. ; Bruze, M. ; Calow, P. ; Dagli, M. L. ; Fryer, A. D. ; Greim, H. ; Miyachi, Y. ; Saurat, J. H. ; Sipes, I. G. / A toxicological and dermatological assessment of macrocyclic lactone and lactide derivatives when used as fragrance ingredients. In: Food and Chemical Toxicology. 2011 ; Vol. 49, No. SUPPL. 2.
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    AU - Fryer, A. D.

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