Pioneer Hi-Bred International Inc., Ankeny, IA, USA.
Food Chem Toxicol. 2009 Nov;47(11):2723-9. doi: 10.1016/j.fct.2009.07.036. Epub 2009 Aug 3.
N-acetyl-glutamic acid (NAG) is an endogenously produced mammalian substance and minor constituent of commonly consumed foods. This paper reports the outcome of genotoxicity and acute and repeated dose (28-day) oral toxicology studies conducted with NAG. No evidence of genotoxicity was observed with NAG in in vitro or in vivo studies. No mortalities or evidence of adverse effects was observed in Sprague-Dawley rats following acute oral gavage with NAG at a dose of 2000 mg/kg of body weight. No adverse effects were observed in rats following repeated dose dietary exposure to NAG at target concentrations corresponding to doses of 100, 500, or 1000 mg/kg of body weight/day for 28 days. All rats survived until scheduled sacrifice and no biologically significant or test substance related differences were observed in body weights, feed consumption, clinical signs, functional observational battery (FOB), ophthalmology, hematology, coagulation, clinical chemistry, organ weights or histopathology of any of the treatment groups. Based on the observed results it is concluded that NAG is not genotoxic or acutely toxic. The no-observed-adverse-effect-level (NOAEL) for systemic toxicity from repeated dose (28-day) dietary exposure to NAG was 914 mg/kg of body weight/day for male rats and 1007 mg/kg of body weight/day for female rats.
N-乙酰谷氨酸（NAG）是一种内源性产生的哺乳动物物质，也是常见食用食品的少量成分。本文报告了对 NAG 进行的遗传毒性以及急性和重复剂量（28 天）口服毒性研究的结果。在体外或体内研究中，NAG 均未显示出遗传毒性。在以 2000mg/kg 体重的剂量经急性口服灌胃给予 NAG 后，Sprague-Dawley 大鼠未观察到死亡或不良反应迹象。在以相当于 100、500 或 1000mg/kg 体重/天的目标浓度经重复剂量饮食暴露于 NAG 28 天后，大鼠未观察到不良反应。所有大鼠均存活至预定处死时间，在体重、饲料消耗、临床体征、功能观察电池（FOB）、眼科、血液学、凝血、临床化学、器官重量或任何治疗组的组织病理学方面均未观察到与生物学意义相关或与测试物质相关的差异。根据观察到的结果，NAG 既没有遗传毒性也没有急性毒性。雄性大鼠重复剂量（28 天）经饮食暴露于 NAG 的全身毒性的无观察到不良效应水平（NOAEL）为 914mg/kg 体重/天，雌性大鼠为 1007mg/kg 体重/天。
