Tallon Mark J, Child Robert B, Blum Jason L
Legal Products Group Ltd, Ely, UK.
School of Chemical Engineering, University of Birmingham, Birmingham, UK.
Pharm Biol. 2025 Apr 29;63(1):357-363. doi: 10.1080/13880209.2025.2499075. Epub 2025 May 6.
As a naturally occurring terpenoid found in L. (Cannabaceae), cannabidiol (CBD) has gained public and industry interest for the purposes of personal well-being as a foodstuff and pharmaceutical. Despite a number of publications on CBD toxicology, many have significant limitations, especially those relating to genotoxicity. These include poor characterization of the CBD extract and/or lack rigor in conforming to accepted regulatory guidelines and best practice. A number of regulatory agencies have highlighted these issues and requested additional genotoxicity data to help ensure the safe use of CBD.
To provide insights into the genotoxicity of a CBD isolate and its lipid carrier.
We have conducted an mammalian cell micronucleus (OECD 487) and a bacterial reverse mutagenicity assay (Ames test) (OECD 471) in a CBD isolate (97% > CBD) with its carrier.
The samples tested were non-mutagenic, as determined in the Ames test. The micronucleus assay conducted was negative for genotoxicity, with no statistically significant increases in the incidences of micronucleated cells observed at any dose compared to negative controls.
These studies confirm that this CBD rich isolate in combination with its carrier, are unlikely to post any genotoxic hazard at exposure levels expected in foods.
大麻二酚（CBD）作为一种天然存在的萜类化合物，存在于大麻属植物（大麻科）中，因其对个人健康有益，作为食品和药品而受到公众和行业的关注。尽管有许多关于CBD毒理学的出版物，但其中许多都有显著局限性，尤其是那些与遗传毒性相关的研究。这些局限性包括CBD提取物的表征不佳和/或在遵循公认的监管指南和最佳实践方面缺乏严谨性。一些监管机构已经强调了这些问题，并要求提供更多的遗传毒性数据，以帮助确保CBD的安全使用。
深入了解一种CBD分离物及其脂质载体的遗传毒性。
我们对一种CBD分离物（CBD含量>97%）及其载体进行了哺乳动物细胞微核试验（经合组织487）和细菌回复突变试验（艾姆斯试验）（经合组织471）。
在艾姆斯试验中，测试样品无致突变性。进行的微核试验对遗传毒性呈阴性，与阴性对照相比，在任何剂量下观察到的微核细胞发生率均无统计学显著增加。
这些研究证实，这种富含CBD的分离物与其载体结合，在食品预期的暴露水平下不太可能产生任何遗传毒性危害。
