Renwick A G
Clinical Pharmacology Group, Allergy and Inflammatory Sciences Research Division, School of Medicine, University of Southampton, Biomedical Sciences Building, Bassett Crescent East, Southampton SO16 7PX, UK.
Toxicol Lett. 2004 Apr 1;149(1-3):163-76. doi: 10.1016/j.toxlet.2003.12.063.
Information on hazard identification, hazard characterisation (including dose-response assessment) and exposure assessment are brought together under risk characterisation in order to provide advice to risk managers. Hazard identification and characterisation define the adverse effects produced by the chemical and are used to determine a health-based guidance value, such as an acceptable daily intake for threshold effects, or an estimate of the intake associated with a predefined level of risk for non-threshold effects. Exposure assessment aims to define average and high intakes, and has to take into account different dietary patterns. Hazard characterisation and exposure data need to be closely inter-related, for example the data should relate to the same life-stages and durations of exposure. Risk characterisation has to be an iterative process in which information on hazard and exposure are matched and any discrepancy taken into account where necessary by the generation of additional data. There is an established method of quantitative risk characterisation for non-threshold effects. A population distribution model is proposed that is applicable to estimate the risk associated with exposure to compounds producing threshold effects.
关于危害识别、危害特征描述(包括剂量反应评估)和暴露评估的信息在风险特征描述中汇总,以便为风险管理者提供建议。危害识别和特征描述确定了化学品产生的不良影响,并用于确定基于健康的指导值,例如阈值效应的每日可接受摄入量,或与非阈值效应的预定义风险水平相关的摄入量估计值。暴露评估旨在确定平均摄入量和高摄入量,并且必须考虑不同的饮食模式。危害特征描述和暴露数据需要紧密相关,例如数据应与相同的生命阶段和暴露持续时间相关。风险特征描述必须是一个迭代过程,在此过程中,危害和暴露信息相互匹配,必要时通过生成额外数据来考虑任何差异。对于非阈值效应,有既定的定量风险特征描述方法。提出了一种适用于估计与接触产生阈值效应的化合物相关风险的人群分布模型。