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Exposure Based Waiving in Environmental Risk Assessment: A Tiered Approach

机译：环境风险评估中基于暴露的豁免：一种分层方法

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摘要

The REACH legislation describes the "Exposure Based Waiving" (EBW) methodology, that allows reduction of animal tests and that facilitates the Chemical Safety Assessments. We introduced a tiered EBW decision strategy for the aquatic environment. Tier 0 in this strategy justifies waiving if it can be demonstrated that exposure of organisms to a chemical will be practically zero (i.e., if no environmental emissions during the full life-cycle of a chemical are to be expected. Tier 1 uses tabular data, derived from physical-chemical properties of a chemical and emission data, to identify whether the environmental exposure levels are less than the conservative toxicological reference value "Threshold of Toxicological Concern" (TTC). To this end, systematic exposure calculations have been carried out with a hypothetical chemical dataset, covering the full chemical spectrum for neutral organic substances. In tier 2, PEC and PNEC are to be assessed probabilistically in order to address the probability of effects. Following this strategy, risk can be shown to be sufficiently low, using minimal exposure and hazard data. Our tiered EBW concept is illustrated by a case study for the substance dibutylphthalate with the endpoint of fresh water aquatic risks.
机译：REACH法规描述了“基于暴露的豁免”（EBW）方法，该方法可减少动物试验并促进化学安全性评估。我们针对水生环境引入了分层的EBW决策策略。如果可以证明有机物在化学品中的暴露量几乎为零（即，如果预计在化学品的整个生命周期内不会排放环境），则该策略中的方法0可以免除。方法1使用表格数据，从化学和排放数据的物理化学特性中得出的数据，以确定环境暴露水平是否低于保守的毒理学参考值“毒理学阈值”（TTC）。为此，已经进行了系统的暴露计算一个假想的化学数据集，涵盖了中性有机物质的整个化学光谱，在第2层中，将对PEC和PNEC进行概率评估，以解决影响的可能性。按照这种策略，使用以下方法可以证明风险足够低最小的接触和危害数据。我们通过对邻苯二甲酸二丁酯进行了案例研究来说明我们的EBW分层概念，其终点为新鲜水水生风险。

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  • 来源
    《Human and ecological risk assessment》 |2011年第6期|p.1173-1192|共20页
  • 作者

    Anne Hollander; Yuri Bruinen de Bruin; J. Arie Vonk; Theo Vermeire; Dik van de Meent;

  • 作者单位

    Radboud University Nijmegen, Institute for Wetland and Water Research(IWWR), Department of Environmental Science, Nijmegen, The Netherlands;

    National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands;

    National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands;

    National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands;

    Radboud University Nijmegen, Institute for Wetland and Water Research(IWWR), Department of Environmental Science, Nijmegen, The Netherlands ,National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands;

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  • 正文语种 eng
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  • 关键词

    exposure-based waiving; EBW; dibutylphtalate; risk assessment; REACH;

    机译：基于暴露的放弃;EBW;邻苯二甲酸二丁酯;风险评估;达到;

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