基因毒性数据的定量评估用于风险评估和监管决策:是时候改变范式了
Benjamin Sachse1, Sebastian Schmeisser1, Jan van Benthem2
1German Federal Institute for Risk Assessment, Max-Dohrn-Straße 8-10, 10589 Berlin, Germany.
Environment international
|January 24, 2026
概括
量化方法提供了更好的方法来评估基因毒性风险,当暴露是不可避免的. 这种从基于危险的评估转变,允许在化学安全和风险管理方面做出更明智的决定.
科学领域:
- 毒理学 毒理学 毒理学
- 化学安全评估 化学安全评估
- 风险管理 风险管理
背景情况:
- 基因毒性评估对于化学品安全至关重要,传统上专注于危害识别.
- 当前基于危险的方法不足,当暴露于基因毒性物质是不可避免的或导致社会经济问题时.
- 在监管风险评估中越来越需要对基因毒性数据进行定量解释.
研究的目的:
- 讨论在基因毒性风险评估中实施定量方法的机遇和挑战.
- 探索从传统的基于危险的评估转向定量解释的范式转变.
- 为成功整合定量方法提出关键考虑因素.
主要方法:
- 由德国联邦风险评估研究所 (BfR) 组织的国际研讨会.
- 监管机构,学术界和行业专家之间的讨论.
- 对实施定量基因毒性评估的关键问题进行分析.
主要成果:
- 传统的基于危险的基因毒性方法是有限的,特别是当不能避免暴露时.
- 量化方法可以更好地描述与基因毒性物质相关的风险.
- 需要集体努力才能安全地过渡到定量风险评估.
结论:
- 定量基因毒性评估使得更明智的风险管理决策成为可能.
- 这种范式转变对于不可避免地暴露于基因毒性物质的情况至关重要.
- 利益相关者之间的合作是成功实施的关键.
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