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Updated: Jan 17, 2026

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The Lambda Select cII Mutation Detection System
Published on: April 26, 2018
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由于有限的低位信息要求,REACH规范中遗漏了多少变异原体?
Rune Hjorth1, Joop de Knecht2, Eva B Wedebye3
1DTU Sustain, Technical University of Denmark, Kgs. Lyngby, Denmark.
Regulatory toxicology and pharmacology : RTP
|September 24, 2025
概括
许多变异原体在低位的REACH注册中被遗漏,因为只需要Ames测试. 包括体外微核试验在内,可以提高每年1-10范围内的突变性物质的识别.
科学领域:
- 化学安全评估 化学安全评估
- 毒理学 毒理学 毒理学
- 监管科学是一种监管科学.
背景情况:
- REACH法规仅要求使用艾姆斯试验来评估工业物质1-10/年的变异性.
- 阴性艾姆斯测试结果可能会阻止进一步的突变性测试,可能会缺少一些突变原体.
- 根据 (Q) SAR 建模,丹麦环保署提供了对变异性进行咨询的自我分类 (ASC).
研究的目的:
- 为了将物质与ASC进行低量REACH注册中的已识别的原体的变异性比较.
- 评估REACH.根据现行变异性测试要求的有效性.
- 建议改进在较低量级别识别变异性物质的方法.
主要方法:
- 与Muta. 的物质比较. 在低位的REACH注册中,ASC对实验性的Ames测试结果.
- 分析REACH档案中可用的体外和体内致变性数据.
- (Q) SAR建模用于咨询自我分类.
主要成果:
- 只有大约四分之一的低量物质具有突变. 2 ASC显示Ames测试结果呈阳性,导致随访.
- 在每年1-10的注册水平上,可能有大量潜在的变异原体未被识别.
- 在低量档案中的体内微核试验数据通常由于缺乏暴露信息而没有确定性.
结论:
- 目前的REACH对低量物质的致变性测试要求不足以全面识别致变性物质.
- 应包括体外微核试验,以补充艾姆斯试验,以便在1-10/年范围内更好地识别突变性.
- 改善体内试验数据报告是必要的,以确保确的结果.
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