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作为一种新型食品的α-甘酸胆的安全评估

Jie Tian¹, Xianghong Ke¹, Yinjing Zhang¹

¹Hubei Provincial Center for Disease Control and Prevention & NHC Specialty Laboratory of Food Safety Risk Assessment and Standard Development, Wuhan, 430079, China.

Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association

|November 22, 2024

概括

阿尔法-甘醇胆 (α-GPC) 作为一种新食品的危险性较低. 研究证实没有急性毒性,没有基因毒性,并为小鼠的亚慢性和原性毒性确定了没有观察到的不良影响水平 (NOAELs).

科学领域:

食品安全食品安全
毒理学毒理学毒理学
营养科学营养科学

背景情况:

阿尔法-甘醇胆 (α-GPC) 是一种新型的食品原料.
全面的安全评估对于新型食品的批准至关重要.

研究的目的:

通过急性口服毒性,次慢性毒性,原性毒性和基因毒性测试来评估α-GPC的安全性.
确定α-GPC暴露的没有观察到的不良影响水平 (NOAELs).

主要方法:

在老鼠中进行急性口服毒性试验 (10.0 g/kg BW).
90天的小慢性口服毒性研究在老鼠.
在怀孕的老鼠中进行了原性毒性研究.
基因毒性测试包括艾姆斯测试,染色体异常和微核测试.

主要成果:

没有观察到10.0g/kgBW的急性毒性.
亚慢性研究显示,高剂量女性的一些影响 (例如,体重降低,肝酶变化).
原性研究表明,高剂量孕妇大鼠的体重增加减少.
基因毒性测试在所有剂量组均呈阴性.

结论:

α-GPC被认为是一种低危险的新食品.
确定的NOAEL:在亚慢性研究中,雌性大鼠每天1000毫克/千克BW,雄性大鼠每天2000毫克/千克BW.
确定的NOAEL:孕鼠每天1000毫克/千克BW,胎鼠每天2000毫克/千克BW.
α-GPC在体外或体内没有表现出基因毒性.

关键词:

剧烈的口服毒性急性毒性基因毒性基因毒性甘酸醇胆的使用方法亚慢性毒性亚慢性毒性原性毒性有毒性

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