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对BMD和TD₅₀方法进行临界比较,以计算N-化物化合物的可接受摄入量

Robert Thomas¹, David J Ponting¹, Andrew Thresher¹

¹Lhasa Limited, Granary Wharf House, 2 Canal Wharf, Leeds, UK.

Archives of toxicology

|January 3, 2025

概括

与传统的TD50模型相比,基准剂量 (BMD) 方法为确定可接受摄入限值提供了更强大的方法. 对致癌物质过渡到BMD极限是可行的,没有重大干扰,利用优越的科学方法.

科学领域:

毒理学毒理学毒理学
风险评估风险评估
致癌的发生是致癌的产生.

背景情况:

致癌剂量50 (TD50) 是致癌效能的标准指标,历史上指导了可接受的摄入量限制.
TD50模型的局限性包括它无法结合DNA修复和补偿机制等生物因素.
基准剂量 (BMD) 方法利用灵活的剂量反应模型来更好地解释这些生物过程.

研究的目的:

为了比较从基于TD50的转换到基于BMD的可接受摄入限值的影响.
评估这种过渡对功效估计的影响,特别是对于尼托拉胺化合物.
评估采用基于BMD的限制与相关的可行性和破坏性.

主要方法:

用一个尼托胺数据集进行案例研究比较.
根据TD50和BMD方法得出的强度估计进行了比较.
分析了关键指标,包括强度分布的第五百分位数,用于特定类别的可接受摄入量.

主要成果:

对于某些化合物,个体强度估计显示TD50和BMD方法之间存在一些差异.
计算类特定可接受摄入量的关键指标没有受到方法的变化显著影响.
相关的尼托胺的功效估计在阅读中变化了3的系数,这是最小的,考虑到更广泛的功效范围.

结论:

采用基于BMD的极限是可以实现的,而不会对现有的监管极限造成重大干扰.
骨干细胞检测方法提供了一种更强大,更科学的方法来评估致癌化合物的风险.
这种过渡支持在建立公共卫生保护极限时使用改进的毒理学建模.

关键词:

可以接受的摄入量基准剂量 (BMD) 是指基准剂量.剂量反应建模剂量反应建模药物的杂质药物的杂质亚胺酸盐的含量是多少在TD50中,TD50是TD50的.

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