Api A M, Belsito D, Bhatia S, Bruze M, Calow P, Dagli M L, Dekant W, Fryer A D, Kromidas L, La Cava S, Lalko J F, Lapczynski A, Liebler D C, Miyachi Y, Politano V T, Ritacco G, Salvito D, Schultz T W, Shen J, Sipes I G, Wall B, Wilcox D K
Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ 07677, USA.
Member RIFM Expert Panel, Columbia University Medical Center, Department of Dermatology, 161 Fort Washington Ave., New York, NY 10032, USA.
Food Chem Toxicol. 2016 Nov;97S:S49-S56. doi: 10.1016/j.fct.2015.12.021. Epub 2015 Dec 23.
The use of this material under current use conditions is supported by the existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization potential, as well as, environmental safety. Repeated dose toxicity was determined to have the most conservative systemic exposure derived NO[A]EL of 37.5 mg/kg/day. A gavage 13-week subchronic toxicity study conducted in mice resulted in a MOE of 5769 while considering 38.4% absorption from skin contact and 100% from inhalation. A MOE of >100 is deemed acceptable.
在当前使用条件下对该材料的使用得到了现有信息的支持。对该材料进行了遗传毒性、重复剂量毒性、发育毒性、生殖毒性、局部呼吸道毒性、光毒性、皮肤致敏潜力以及环境安全性评估。重复剂量毒性确定具有最保守的全身暴露推导无可见不良效应水平为37.5毫克/千克/天。在小鼠中进行的一项灌胃13周亚慢性毒性研究,在考虑经皮肤接触吸收38.4%和经吸入吸收100%的情况下,得出的安全系数为5769。安全系数>100被认为是可接受的。