艾姆斯试验结果在实验室内可重复性:是否需要重复测试?
Errol Zeiger1, Constance A Mitchell2, Stefan Pfuhler3
1Errol Zeiger Consulting, Chapel Hill, North Carolina, USA.
Environmental and molecular mutagenesis
|April 23, 2024
概括
艾姆斯试验在实验室内显示出高的可重复性,用于检测变异原体,这对于化学品和植物等复杂混合物的监管安全评估至关重要.
科学领域:
- 毒理学 毒理学 毒理学
- 基因毒性测试 基因毒性测试
- 化学安全评估 化学安全评估
背景情况:
- 艾姆斯试验是一种监管标准,用于评估突变性和致癌潜力.
- 评估复杂混合物 (如植物提取物) 的突变性,需要了解艾姆斯测试的可靠性.
- 国家毒理学计划 (NTP) 数据库为超过3000种物质提供了广泛的Ames测试数据.
研究的目的:
- 检查艾姆斯试验的实验室内可复制性.
- 评估测试对单个化学品的性能及其对复杂混合物的潜力.
- 为优化未来的Ames测试协议提供上下文.
主要方法:
- 对NTP Ames测试数据库的分析,重点关注经济合作与发展组织测试指南471.
- 使用标准预化方案评估可再生性,使用10%的鼠肝S9进行代谢激活.
- 根据不同S9度 (10%和30%) 和物种 (老鼠和仓鼠) 的评估.
主要成果:
- 在实验室内可重复性高的负面Ames测试结果 (95%-99%).
- 在TA98和TA100菌株中,阳性结果的可复制性在老鼠或仓鼠S9.9时≥90%.
- 在模两可的反应中观察到较低的可重复性 (<50%).
结论:
- 艾姆斯试验在实验室内表现出强大的可重复性,可以获得明确的负和正结果.
- 这些发现支持Ames测试在选单个化学物质和复杂混合物的实用性.
- 结果将有助于制定用于突变致病性测试的标准化协议.
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