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, 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.
Columbia University Medical Center, Department of Dermatology, 161 Fort Washington Ave., New York, NY, 10032, USA.
Food Chem Toxicol. 2016 Nov;97S:S57-S68. doi: 10.1016/j.fct.2016.01.020. Epub 2016 Jan 30.
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. Developmental toxicity was determined to have the most conservative systemic exposure derived NO[A]EL of 100 mg/kg/day. A gavage developmental toxicity study conducted in rats on a suitable read across analog resulted in aMOE of 3571 while considering 78.7% absorption from skin contact and 100% from inhalation. A MOE of >100 is deemed acceptable.
在当前使用条件下,现有信息支持该材料的使用。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。发育毒性方面确定的最保守的全身暴露推导无作用[阈]剂量为100毫克/千克/天。在大鼠身上对一种合适的类推物进行的灌胃发育毒性研究得出的安全系数为3571,同时考虑到经皮肤接触的吸收率为78.7%,经吸入的吸收率为100%。安全系数大于100被认为是可接受的。