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皮肤敏感性的下一代定量风险评估 - - 基于体外数据的回归模型的应用,以估计出发点

Isabelle Lee¹, Mihwa Na², Maura Lavelle¹

¹Research Institute for Fragrance Materials, Inc., 1200 MacArthur Blvd, Suite 306, Mahwah, NJ, USA.

Regulatory toxicology and pharmacology : RTP

|October 16, 2025

概括

皮肤敏感化的定量风险评估 (QRA) 现在使用体外回归模型来确定安全的化学度. 这种新方法 (NAM-NESIL) 为消费者产品安全提供了一种可靠的无动物替代方案.

科学领域:

毒理学毒理学毒理学
风险评估风险评估
皮肤敏感化皮肤敏感化

背景情况:

对皮肤敏感性的定量风险评估 (QRA) 对于在消费品中确定皮肤敏感剂的安全限值至关重要.
香水行业的QRA2方法使用无预期敏感化诱导水平 (NESIL) 作为参考剂量.
新兴的体外试验方法为动物试验提供了替代品,用于评估功效和定量出发点 (PoD) 计算.

研究的目的:

提出将体外回归模型纳入皮肤敏感剂下一代风险评估 (NGRA) 的框架.
为了证明使用体外数据计算新方法方法 NESIL (NAM-NESIL) 值的计算.
使用拟议框架评估含有特定敏感剂的消费产品的安全性.

主要方法:

使用体外方法进行危险评估 (经合组织准则497).
通过回归模型进行定量PoD计算.
应用QRA2框架与NAM-NESIL值和不确定性因子.

主要成果:

使用p-mentha-1,8-dien-7-al和3-propylidenephthalide的案例研究产生了可接受的暴露水平 (AEL).
AEL与消费者暴露水平 (CEL) 的比率表示除臭剂和石条的安全当前使用水平.
基于NAM-NESILs的QRA结果与历史的人类衍生的NESILs保持一致,证实了体外模型的可靠性.

结论:

提出的框架有效地将体外回归模型纳入皮肤敏化剂的QRA.
这种新方法方法 (NAM-NESIL) 为PoD衍生提供了一个可靠的,可能无动物的替代方案.
这些发现支持使用体外模型,减少对监管风险评估的体外数据的依赖.

关键词:

人类细胞系激活试验在体外回归模型.克拉提诺SensTMTM可以让人感觉到动力直接的反应性测定试验.这些是NAMs.恩格拉 (NGRA) 是一个新方法方法论新方法方法论下一代风险评估是下一代风险评估.在警察局,警察局.起点的起点起点的起点在h-CLAT中使用.在 kDPRA 找

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