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一个工作流程,实际应用真实剂量考虑在体外测试下一代风险评估的实践

Beate Nicol¹, Evita Vandenbossche-Goddard¹, Charlotte Thorpe¹

¹Unilever Safety and Environmental Assurance Centre, Colworth Science Park, Sharnbrook, Bedford, Bedfordshire MK44 1LQ, UK.

|May 8, 2024

概括

下一代风险评估 (NGRA) 从动物试验转向in silico和in vitro模型. 这项研究评估了名义度是否准确地反映了可靠的NGRA的生物有效剂量,确保了保守的决策.

科学领域:

毒理学和化学安全
在维特罗和在模拟模型.
监管科学监管科学

背景情况:

科学界正在远离动物试验,转向下一代风险评估 (NGRA).
NGRA依赖于in silico和in vitro数据,在确定目标部位的实际剂量时引入不确定性.
使用名义度等替代剂量指标,但它们在反映生物有效剂量的准确性对于可靠的风险评估至关重要.

研究的目的:

为了说明体外剂量考量如何可以表征体外剂量,请参阅本文.
真正剂量的真实剂量
为了NGRA.
建立对理解生物有效剂量的信心 in in vitro用于确定出发点 (PoDs) 的系统.
提出并应用一个工作流程来评估名义试验度作为NGRA中的保守剂量指标.

主要方法:

使用了40种案例研究化学物质来评估体外剂量指标.
开发了一种检查化学性质的工作流程:挥发性,稳定性,水性,与塑料和血清结合,以及溶解性.
纳入模型,以预测某些化学参数.

主要成果:

对于大多数化学品,名义度在风险评估中提供了保守的剂量指标.
确定了几种化学物质,其名义度可能低估了人体体体内风险.
通过描述实际效应度来完善风险评估的建议方法.

结论:

拟议的工作流有助于评估名义度对NGRA的适用性.
虽然通常是保守的,但名义度需要对特定化学品进行仔细评估.
描述实际效果度对于准确的风险评估和改进NGRA至关重要.

关键词:

风险投资评估风险投资评估在状的中.新方法方法论 (NAM) 试管体内下一代风险评估 (NGRA) 是一种风险评估.监管机构接受的接受.风险评估风险评估风险评估

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