现在 (2025) 准备样本,然后:从13年的纳米材料监管安全测试中吸取教训
Kirsten Rasmussen1, Richard Handy2, Ivana Vinković Vrček3
1European Commission, Joint Research Centre (JRC), Ispra, Italy.
NanoImpact
|February 8, 2026
概括
更新的样品制备和剂量测量指南 (GSPD) 通过详细说明先进的样品制备和剂量估计方法,增强了纳米材料安全测试. 它反映了十年的进步,整合了物理,化学,哺乳动物和环境评估的新见解.
科学领域:
- 环境科学 环境科学
- 毒理学 毒理学 毒理学
- 材料科学 材料科学 材料科学
背景情况:
- 制造纳米材料的监管测试需要标准化的安全评估指南.
- 为此,经济合作与发展组织 (OECD) 制定了测试指南和指导文件.
- 样品制备和剂量测量指南 (GSPD) 是纳米材料安全测试的一个关键文件.
研究的目的:
- 提供2025年出版的第三版GSPD新元素的概述.
- 为突出纳米材料安全测试的样品制备和剂量测量的进步.
- 解决纳米材料测试中的新知识和实践问题的整合.
主要方法:
- 该GSPD整合了各种终点的样本准备协议的进展.
- 它包含了对剂量计和有效剂量估计的更深入的理解,现在得到了in silico工具的支持.
- 该文件强调系统地考虑介质组成对纳米材料行为的影响.
主要成果:
- 第三版GSPD反映了在过去十年中在解决样本准备和剂量计问题方面取得的重大进展.
- 新的信息包括对物理化学性质 (例如,疏水性) 的样本制备,体外检测和哺乳动物毒性.
- 该GSPD承认缺乏总体样本准备协议,但详细说明了关键的实际问题和进展.
结论:
- 更新的GSPD为制造纳米材料的监管测试提供了关键的指导.
- 它反映了对样品制备和剂量计的最佳实践日益增长的共识.
- 该文件标志着知识的实质性飞跃,特别是在体外和哺乳动物毒性测试方面,并包括扩展的词汇表.
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