Columbia University Medical Center, Department of Dermatology, 161 Fort Washington Ave., New York, NY 10032, USA.
Food Chem Toxicol. 2012 Oct;50 Suppl 3:S517-56. doi: 10.1016/j.fct.2012.04.019. Epub 2012 May 2.
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.
经全面文献检索，对环戊酮和环戊烯酮类香料成分的安全性进行了严格评估。对于高端用户，在含醇水制品中，经计算的最大皮肤暴露量从 0.002%到 15.16%不等；经系统暴露量从 0.0003 到 0.7122mg/kg/天不等。环戊酮和环戊烯酮的急性毒性较低，在重复剂量研究中没有显著毒性。在细菌和哺乳动物细胞系检测中未观察到致突变或遗传毒性活性。未观察到发育毒性。与当前使用水平相关的人类皮肤刺激性最小证据。11 种材料未经稀释进行眼部刺激性测试；其中三种被认为是刺激性物质。在测试的九种材料中未观察到光毒性和光致敏反应。在高于当前报告使用浓度的情况下，14 种材料在 HRIPT 或最大用量测试中不具有致敏性。2-己烯基环戊酮、2-庚烯基环戊-1-酮和 3-甲基-2-（戊氧基）-2-环戊烯-1-酮是弱致敏剂，并且符合 IFRA 标准。在当前使用水平下，环戊酮和环戊烯酮致敏的风险通常较小。专家组认为，在报告的使用水平和暴露水平下，作为香料成分的环戊酮和环戊烯酮不存在安全问题。
