基因毒性的现状和未来挑战经合组织对纳米材料的测试指南:研讨会报告
Shareen H Doak1, Cristina Andreoli2, Michael J Burgum1
1Institute of Life Science, Swansea University Medical School, Singelton Park, Swansea, SA2 8PP Wales, United Kingdom.
Mutagenesis
|May 26, 2023
概括
对纳米材料的基因毒性测试需要更新经合组织指导方针和新方法方法 (NAM). 国际专家建议NAM用于更好的纳米材料安全评估和监管接受.
科学领域:
- 纳米材料安全性和毒理学
- 基因毒理学和风险评估
背景情况:
- 标准的基因毒性测试方法需要适应纳米材料.
- 现有的经合组织测试指南 (TG) 和指导文件 (GD) 对于纳米特异性评估是不够的.
- 新方法方法 (NAM) 提供了评估纳米材料基因毒性机制的潜力.
研究的目的:
- 解决纳米材料的基因毒性测试方面的挑战.
- 讨论在纳米材料监管框架中实施NAM.
- 促进科学家和监管机构之间的合作,以改善纳米材料安全评估.
主要方法:
- 召开了一场国际研讨会,与各种利益相关者 (监管机构,工业,学术界) 合作.
- 专家讨论的重点是目前测试方法,表征,采用和行动方式方面的缺陷.
- 评估了NAM生成数据在监管风险评估中的作用和接受.
主要成果:
- 在标准测试中发现的缺陷:暴露方案,物理化学表征,细胞吸收和基因毒性覆盖.
- 在支持纳米材料基因毒性评估的NAM的重要性上达成共识.
- 强调需要在证据权重方法中制定监管清晰度和接受NAM数据.
结论:
- 开发纳米特异性的OECD TGs和GDs至关重要.
- 对于纳米材料的综合性基因毒性评估,NAM是必不可少的.
- 科学家和监管机构之间的加强参与对于有效的风险评估和NAM数据的监管接受至关重要.
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