title: A toxicologic and dermatologic assessment of cyclopentanones and cyclopentenones when used as fragrance ingredients.
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.
authors.affiliation: Columbia University Medical Center, Department of Dermatology, 161 Fort Washington Ave., New York, NY 10032, USA.
authors.forename: D
authors.initials: D
authors.lastname: Belsito
authors.forename: D
authors.initials: D
authors.lastname: Bickers
authors.forename: M
authors.initials: M
authors.lastname: Bruze
authors.forename: P
authors.initials: P
authors.lastname: Calow
authors.forename: M L
authors.initials: ML
authors.lastname: Dagli
authors.forename: W
authors.initials: W
authors.lastname: Dekant
authors.forename: A D
authors.initials: AD
authors.lastname: Fryer
authors.forename: H
authors.initials: H
authors.lastname: Greim
authors.forename: Y
authors.initials: Y
authors.lastname: Miyachi
authors.forename: J H
authors.initials: JH
authors.lastname: Saurat
authors.forename: I G
authors.initials: IG
authors.lastname: Sipes
mesh_terms: D000818:Animals; D003517:Cyclopentanes / Q000493:pharmacokinetics / Q000633:toxicity*; D006801:Humans; D010476:Perfume; D012867:Skin / Q000187:drug effects*; D018675:Toxicity Tests
chemical_list: D003517:Cyclopentanes; D010476:Perfume