University of Missouri (Kansas City), c/o American Dermatology Associates, LLC, 6333 Long Avenue, Third Floor, Shawnee, KS 66216, USA.
Food Chem Toxicol. 2010 Jul;48 Suppl 4:S1-46. doi: 10.1016/j.fct.2010.05.046.
The Branched Chain Saturated Alcohol (BCSA) group of fragrance ingredients was evaluated for safety. In humans, no evidence of skin irritation was found at concentrations of 2-10%. Undiluted, 11 materials evaluated caused moderate to severe eye irritation. As current end product use levels are between 0.001% and 1.7%, eye irritation is not a concern. The materials have no or low sensitizing potential. For individuals who are already sensitized, an elicitation reaction is possible. Due to lack of UVA/UVB light-absorbing structures, and review of phototoxic/photoallergy data, the BCSA are not expected to elicit phototoxicity or photoallergy. The 15 materials tested have a low order of acute toxicity. Following repeated application, seven BCSA tested were of low systemic toxicity. Studies performed on eight BCSA and three metabolites show no in vivo or in vitro genotoxicity. A valid carcinogenicity study showed that 2-ethyl-1-hexanol is a weak inducer of liver tumors in female mice, however, the relevance of this effect and mode of action to humans is still a matter of debate. The Panel is of the opinion that there are no safety concerns regarding BCSA under the present levels of use and exposure.
支链饱和醇（BCSA）组香料成分的安全性进行了评估。在人类中，在 2-10%的浓度下没有发现皮肤刺激的证据。未经稀释，11 种评估材料会引起中度至重度眼部刺激。由于目前的最终产品使用水平在 0.001%至 1.7%之间，因此眼部刺激不是问题。这些材料没有或低致敏潜力。对于已经致敏的个体，可能会引发诱发反应。由于缺乏 UVA/UVB 光吸收结构，以及光毒性/光过敏数据的审查，BCSA 预计不会引起光毒性或光过敏。这 15 种测试材料具有较低的急性毒性。在重复应用后，七种 BCSA 被测试为低系统毒性。对八种 BCSA 和三种代谢物进行的研究表明没有体内或体外遗传毒性。一项有效的致癌性研究表明，2-乙基-1-己醇是雌性小鼠肝脏肿瘤的弱诱导剂，然而，这种效应及其作用模式与人类的相关性仍然存在争议。专家小组认为，在目前的使用和暴露水平下，BCSA 不存在安全问题。
