Columbia University Medical Center, Department of Dermatology, 161 Fort Washington Ave., New York, NY 10032, USA.
Food Chem Toxicol. 2012 Sep;50 Suppl 2:S269-313. doi: 10.1016/j.fct.2012.02.091. Epub 2012 Mar 9.
The aryl alkyl alcohol simple acid ester derivatives (AAASAE) group of fragrance ingredients was critically evaluated for safety following a complete literature search of the pertinent data. For high end users, calculated maximum skin exposures vary widely from 0.01% to 4.17%. AAASAE exhibit a common route of primary metabolism by carboxylesterases resulting in the formation of the simple acid and an aryl alkyl alcohol. They have low acute toxicity. No significant toxicity was observed in repeat-dose toxicity tests. There was no evidence of carcinogenicity of benzyl alcohol when it was administered in the feed; gavage studies resulted in pancreatic carcinogenesis due to the corn oil vehicle. The AAASAE are not mutagenic in bacterial systems or in vitro in mammalian cells, and have little to no in vivo genotoxicity. Reproductive and developmental toxicity data show no indication of adverse effects on reproductive function and NOELs for maternal and developmental toxicity are far in excess of current exposure levels. The AAASAE are generally not irritating or sensitizing at the current levels of exposure. The Panel is of the opinion that there are no safety concerns regarding the AAASAE at the current levels of use and exposure.
经全面检索相关数据,对芳基烷基醇简单酸酯衍生物(AAASAE)类香料成分进行了安全性的关键性评估。对于高端用户,经计算得出的皮肤最大暴露量差异很大,范围在 0.01%至 4.17%之间。AAASAE 通过羧酸酯酶发生常见的初级代谢,生成简单酸和芳基烷基醇。它们具有较低的急性毒性。在重复剂量毒性试验中未观察到显著毒性。当苯甲醇经饲料给予时,没有致癌性的证据;灌胃研究由于玉米油载体导致胰腺癌发生。AAASAE 在细菌系统或哺乳动物细胞体外均无致突变性,体内遗传毒性也很小或没有。生殖和发育毒性数据显示,对生殖功能没有不良影响,母体和发育毒性的无观察到不良效应水平远超过当前的暴露水平。AAASAE 在当前的暴露水平下通常不会引起刺激或致敏。专家小组认为,在目前的使用和暴露水平下,AAASAE 不存在安全问题。