一种大麻sativa的基因毒性评估L.提取物
Mark J Tallon1, Robert B Child1,2, Jason L Blum3
1Legal Products Group Ltd, Ely, UK.
Pharmaceutical biology
|May 6, 2025
概括
在Ames和微核测试中,大麻素 (CBD) 隔离物及其脂质载体没有显示出基因毒性危险. 这些发现支持在预期暴露水平下在食品中安全使用CBD产品.
科学领域:
- 药理学 药理学是指药理学的学科.
- 毒理学 毒理学 毒理学
- 大麻素科学 大麻素科学
背景情况:
- Cannabidiol (CBD) 是一种来自Cannabis sativa的类化合物,在健康,食品和制药方面非常受欢迎.
- 现有的CBD毒理数据往往缺乏严格性和监管合规性,特别是在基因毒性方面.
- 监管机构需要更多的基因毒性数据来进行安全的CBD产品评估.
研究的目的:
- 评估纯化CBD分离物及其脂质载体的基因毒性潜力.
- 为了解决CBD对消费产品的安全性评估中的数据缺口.
主要方法:
- 进行了体外哺乳动物细胞微核试验 (OECD 487).
- 进行了细菌逆转致变性试验 (阿梅斯试验) (OECD 471).
- 测试了一种CBD分离物 (≥97%CBD) 与其脂质载体.
主要成果:
- 在Ames测试中,CBD分离物和载体是非变异性的.
- 在体外微核试验中,对基因毒性产生了负结果.
- 在任何测试剂量下都没有观察到微核细胞的显著增加.
结论:
- 经过测试的CBD分离物和载体组合不构成基因毒性风险.
- 结果支持这种CBD产品在预期暴露水平下用于食品的安全性.
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