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在体内基因毒性测试策略:第八届基因毒性测试国际研讨会 (IWGT) 的报告

Carol Beevers¹, Yoshifumi Uno², Krista Meurer³

¹Corteva Agriscience, Oxford, UK.

Environmental and molecular mutagenesis

|November 9, 2023

概括

负的红细胞微核 (MN) 测试可接受,骨髓暴露足够,遵循经合组织的指导方针. 对非血造组织中的MN测定和彗星测定标准化的进一步研究是必要的.

科学领域:

基因毒性测试是指基因毒性测试.
在体内测试的体内测试.
监管科学是一种监管科学.

背景情况:

活体内工作组解决了基因毒性测试中的关键问题.
主题包括负微核 (MN) 测试的最大剂量,非血液构造性MN测试的验证和彗星测试挑战.

研究的目的:

在体内基因毒性测试的可接受实践上达成共识.
评估MN和彗星测定的验证状态和适用性.

主要方法:

专家小组讨论和共识建设.
审查现有数据和指导方针 (OECD TG 474).

主要成果:

在足够的骨髓暴露下接受负性红细胞MN研究的标准上达成协议.
肝脏MN检测验证了经合组织TG的发展,但需要研究年龄影响.
胃肠道MN测定对特定的新原体有用;考虑了OECD TG474的附录.
对彗星测定数据的解释需要对历史对照数据 (HCD) 和细胞毒性标记者保持谨慎.

结论:

在特定暴露条件下,负红细胞MN研究是可以接受的.
对非造血性MN试验和彗星试验需要进一步的验证和标准化.
对于彗星测定解释,需要标准化细胞毒性标记物.

关键词:

消化道微核的微核基因毒性测试国际研讨会 (IWGT)彗星测试试验彗星测试试验遗传毒理学遗传毒理学在活体中,活体中肝脏微核的发生

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