大麻二醇的基因毒性评估
Rayetta G Henderson1, Brian T Welsh2, Kristen R Trexler3
1ToxStrategies, Inc., Wilmington, NC, 28411, USA.
Regulatory toxicology and pharmacology : RTP
|June 4, 2023
概括
用三项测试评估了大麻素 (CBD) 的基因毒性潜力. 纯CBD分离物在体外或体内没有表现出任何基因毒性危险,这表明消费者健康使用的安全性.
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
- 遗传学 是一个遗传学.
背景情况:
- 消费者对大麻 (CBD) 的健康兴趣很高,但安全性数据,特别是基因毒性,是有限的.
- 现有研究往往缺乏质量,原因是不纯粹的试验材料或低于最佳的研究设计,造成监管数据缺口.
研究的目的:
- 为了全面评估纯CBD分离物的基因毒性潜力.
- 为了解决监管机构和消费者对CBD安全性的数据差距.
主要方法:
- 根据经合组织的指导方针,进行了三项标准基因毒性测定.
- 试验室内测试包括微生物逆变异试验 (Ames试验) 和在人体细胞中试验室内微核试验.
- 在老鼠身上进行了体内微核试验,对CBD及其代谢物进行了生物分析.
主要成果:
- 在体外微生物逆转基因突变试验中,CBD分离物的基因毒性测试结果为负,高达5000μg/盘.
- 在人体细胞中的体外微核试验中,CBD分离物的检测结果为阴性,高达10-11μg/mL.
- 在小鼠的体内微核试验中,CBD分离物在高达1000mg/kg-bw/d的剂量下呈阴性,已确认与剂量相关的血暴露.
结论:
- 进行的基因毒性测定表明,纯CBD分离物不太可能构成基因毒性危险.
- 这些发现为关于CBD使用的公共领域提供了关键的安全数据.
- 这项研究支持CBD在消费者健康应用中的安全性.
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