Ajinomoto Co., Inc., 15-1 Kyobashi 1-Chome, Chuo-ku, Tokyo 104-8315, Japan.
Food Chem Toxicol. 2011 Nov;49 Suppl 1:S2-7. doi: 10.1016/j.fct.2011.06.046.
Advantame is an N-substituted (aspartic acid portion) derivative of aspartame that is similar in structure to neotame, another N-substituted aspartame. An extensive series of studies, were conducted on advantame to define the pharmacokinetics and metabolism in various species, subchronic and chronic toxicity in the rat and dog, carcinogenicity in the rat and mouse, genotoxicity, reproductive, and developmental toxicity, and human tolerability studies. The results of these studies, presented in overview in the present publication, and in greater detail in the accompanying publications, show that advantame is well tolerated by both animals and humans and does not possess systemic toxicity. The metabolic data demonstrate that the animal species used in the toxicity testing are relevant to the evaluation of human safety. The no-observed-adverse-effect levels (NOAELs) identified in the animal studies in which advantame was administered in the diet were generally the highest doses tested. Under the anticipated conditions of use, the predicted intakes of advantame are about 20,000- to 70,000-fold lower than the identified animal study NOAEL values. The results of the animal toxicology and human trial data support the safety of use of advantame in food.
阿力甜是阿斯巴甜的 N-取代（天冬氨酸部分）衍生物，其结构与纽甜相似，纽甜也是另一种 N-取代的阿斯巴甜。对阿力甜进行了广泛的研究，以确定其在各种物种中的药代动力学和代谢、大鼠和狗的亚慢性和慢性毒性、大鼠和小鼠的致癌性、遗传毒性、生殖和发育毒性以及人类耐受性研究。这些研究的结果在本出版物的概述中以及在随附的出版物中进行了更详细的介绍，结果表明阿力甜在动物和人类中均具有良好的耐受性，并且没有全身毒性。代谢数据表明，在毒性测试中使用的动物物种与人类安全性评估相关。在以饮食形式给予阿力甜的动物研究中确定的无明显不良效应水平（NOAEL）通常是最高测试剂量。在预期的使用条件下，预计阿力甜的摄入量比确定的动物研究 NOAEL 值低约 20,000 至 70,000 倍。动物毒理学和人体试验数据的结果支持在食品中使用阿力甜的安全性。
