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N-乙酰-L-丝氨酸的毒理学研究。

Toxicology studies with N-acetyl-L-serine.

机构信息

Pioneer Hi-Bred International Inc, Ankeny, IA, United States.

出版信息

Food Chem Toxicol. 2010 Aug-Sep;48(8-9):2193-9. doi: 10.1016/j.fct.2010.05.045. Epub 2010 May 19.

DOI:10.1016/j.fct.2010.05.045
PMID:20488221
Abstract

N-Acetyl-L-serine (NAS) is a component of dietary proteins and a minor constituent of foods as a free amino acid. The current paper reports the outcome of toxicology studies conducted to assess the safety of NAS. No evidence of mutagenicity was observed in the reverse bacterial mutation assay. Genotoxicity was not observed in the bone marrow micronucleus assay conducted in mice. No mortalities or evidence of adverse effects were observed in Sprague-Dawley (SD) rats following acute oral administration at a dose of 2000 mg of NAS/kg of body weight. Similarly, no evidence of adverse effects was observed in SD rats following repeated dose dietary exposure (28-days) to targeted doses of 100, 500, or 1000 mg of NAS/kg of body weight/day. All rats survived until scheduled sacrifice and no biologically significant differences were observed in any of the response variables from the NAS exposure groups compared with untreated control groups. Based on these results, NAS does not represent a risk for mutagenicity or genotoxicity, is not acutely toxic, and the no-observed-adverse-effect-level (NOAEL) for systemic toxicity from repeated dose dietary exposure to NAS is 839.7 and 893.6 mg of NAS/kg of body weight/day for male and female rats, respectively.

摘要

N-乙酰-L-丝氨酸(NAS)是膳食蛋白质的组成部分,也是食物中游离氨基酸的少量成分。本文件报告了为评估 NAS 的安全性而进行的毒理学研究结果。在反向细菌突变检测中未观察到致突变性。在进行的小鼠骨髓微核检测中未观察到遗传毒性。在经口给予 2000mg/kg 体重的 NAS 后,SD 大鼠未观察到死亡率或不良反应迹象。同样,在经口重复给予目标剂量(100、500 或 1000mg/kg 体重/天)28 天后,SD 大鼠也未观察到 NAS 暴露组有任何不良反应迹象。所有大鼠均存活至预定处死时间,与未处理的对照组相比,NAS 暴露组的任何反应变量均无生物学意义上的差异。基于这些结果,NAS 不具有致突变性或遗传毒性风险,无急性毒性,经口重复给予 NAS 导致的系统毒性的无观察到不良效应水平(NOAEL)分别为雄性和雌性大鼠 839.7 和 893.6mg/kg 体重/天。

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