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.
Columbia University Medical Center, Department of Dermatology, 161 Fort Washington Ave., New York, NY 10032, USA.
Food Chem Toxicol. 2015 Oct;84 Suppl:S110-21. doi: 10.1016/j.fct.2015.09.014. Epub 2015 Sep 28.
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 using to have the most conservative systemic exposure derived NOAEL of 47 mg/kg/day. A dietary 13-week subchronic toxicity study conducted in rats on a suitable read across analog resulted in a MOE of 2350 while considering 10.3% 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。重复剂量毒性测定得出最保守的全身暴露无观察到有害作用水平为47毫克/千克/天。在大鼠身上对一种合适的类推物进行的为期13周的饮食亚慢性毒性研究得出,在考虑经皮肤接触吸收10.3%和经吸入吸收100%的情况下,安全系数为2350。安全系数>100被认为是可接受的。