Pioneer Hi-Bred International, Inc., 2450 SE Oak Tree Court, Ankeny, IA 50021, USA.
Food Chem Toxicol. 2010 May;48(5):1321-7. doi: 10.1016/j.fct.2010.02.031. Epub 2010 Feb 25.
N-acetylglycine (NAGly) has been identified as a minor constituent of numerous foods. The current paper reports the outcome of in vitro and in vivo genotoxicity, acute oral and repeated dose dietary toxicology studies conducted with NAGly. No evidence of genotoxicity was observed with NAGly in vitro bacterial tester strains or in vivo bone marrow micronucleus studies conducted in mice. No mortalities or evidence of adverse effects were observed in Sprague-Dawley rats following acute oral gavage with NAGly at a dose of 2000 mg/kg of body weight or following repeated dose dietary exposure to NAGly at targeted doses of 100, 500, or 1000 mg/kg of body weight/day for 28 days. No biologically significant or test substance related differences were observed in body weights, feed consumption, or clinical pathology response variables in any of the treatment groups. Based on these results it was concluded that NAGly is not genotoxic or acutely toxic. Further, the no-observed adverse-effect-level (NOAEL) for systemic toxicity from repeated dose dietary exposure to NAGly was 898.9 mg/kg of body weight/day for male rats and 989.9 mg/kg of body weight/day for female rats.
N-乙酰甘氨酸（NAGly）已被确定为许多食物的少量成分。本文件报告了使用 NAGly 进行的体外和体内遗传毒性、急性口服和重复剂量饮食毒理学研究的结果。在体外细菌测试菌株或在体内小鼠骨髓微核研究中，未观察到 NAGly 具有遗传毒性。在以 2000 毫克/千克体重的剂量对 Sprague-Dawley 大鼠进行急性口服灌胃或在 28 天内以 100、500 或 1000 毫克/千克体重/天的目标剂量进行重复剂量饮食暴露后，未观察到 NAGly 有死亡或不良影响的证据。在任何处理组中，体重、饲料消耗或临床病理反应变量均未观察到与生物意义相关或与测试物质相关的差异。基于这些结果，可以得出结论，NAGly 没有遗传毒性或急性毒性。此外，重复剂量饮食暴露于 NAGly 的全身毒性的无观察不良效应水平（NOAEL）为雄性大鼠 898.9 毫克/千克体重/天，雌性大鼠 989.9 毫克/千克体重/天。
