在临床前对L-甲基叶酸的安全性评估
Keith Morris-Schaffer1, Sarah Dahlberg2, Esther Johann3
1Exponent Inc., Center for Chemical Regulation and Food Safety, 485 Lexington Avenue, Suite, 2200, New York, NY, USA.
概括
1-甲基叶酸 (L-5-MTHF-Na) 是食品中安全的叶酸来源. 临床前研究在老鼠的重复剂量毒性测试中没有显示出基因毒性或不良影响.
科学领域:
- 营养科学 营养科学
- 毒理学 毒理学 毒理学
背景情况:
- 1-甲基叶酸 (L-5-MTHF-Na) 被提议作为人类食品中叶酸的替代叶酸来源.
- 叶酸对于许多生理功能至关重要.
研究的目的:
- 评估用于人类食品的l-甲基叶酸盐 (L-5-MTHF-Na) 的安全性.
- 评估L-5-MTHF-Na. 的基因毒性和重复剂量毒性.
主要方法:
- 基因毒性测试包括细菌逆变异试验,体外染色体异常试验和体外微核试验.
- 重复剂量毒性研究涉及14天和90天的口服 gavage Administration 在老鼠中,每天高达1000mg/kg bw.
主要成果:
- L-5-MTHF-Na没有表现出任何突变性或细胞遗传效应.
- 在重复剂量研究中的所有终点中,在老鼠中没有观察到与治疗相关的不良影响.
- 发现了肌酸激酶的适应性变化,但被认为没有不利影响.
结论:
- 1-甲基叶酸 (L-5-MTHF-Na) 在食叶酸补充剂中表现出安全的特征.
- 这些发现与之前对甲基叶酸 (L-5-MTHF-Ca) 的研究一致.
- 作为叶酸来源,L-5-MTHF-Na适合用于营养目的.
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