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对体外发育神经毒性测试测定结果的观点:专家小组审查

D R Juberg¹, D A Fox², P A Forcelli³

¹Juberg Toxicology Consulting LLC, Indianapolis, IN, USA.

Regulatory toxicology and pharmacology : RTP

|July 13, 2023

概括

在体外DNT测试电池 (DNT IVB) 显示了化学发育神经毒性 (DNT) 的初始查的希望. 然而,它尚未完全取代体内测试来评估人类DNT风险.

科学领域:

毒理学毒理学毒理学
神经科学是一个神经科学.
监管科学监管科学

背景情况:

关于化学发育神经毒性 (DNT) 的担忧日益增加,历史上一直依赖体内测试.
新方法方法 (NAMs),包括DNT体外试验电池 (DNT IVB),已经出现,以加强查,减少动物使用,提高成本效益.

研究的目的:

为了解决专家对体外DNT测试数据的解释.
评估DNT IVB在监管决策方面的现有能力和局限性.

主要方法:

召集专家小组讨论并就DNT IVB数据解释达成共识.
审查了DNT IVB捕捉复杂发育神经毒性结果的能力.

主要成果:

DNT IVB适用于初始查,但不是人类DNT评估的完整替代品.
目前,DNT IVB无法充分评估关键的发育里程碑,如行为本能,运动活动,感官功能和学习/记忆.

结论:

在目前的状态下,DNT IVB不能完全捕捉发育中的神经系统的复杂性.
在DNT IVB可以被整合到化学安全决策的全球监管框架之前,进一步的数据生成和验证是必不可少的.

关键词:

其他替代品替代品化学品化学品化学品化学品发展性的发展.在体外 (in vitro) 的情况下.这些是NAMs.神经毒性神经毒性经合组织经济合作与发展组织TG 426

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