Van de Sandt Johannes J M, Dellarco Mike, Van Hemmen Joop J
TNO Quality of Life, Department of Food & Chemical Risk Analysis, Zeist, The Netherlands.
J Expo Sci Environ Epidemiol. 2007 Dec;17 Suppl 1:S38-47. doi: 10.1038/sj.jes.7500579. Epub 2007 Apr 18.
Exposure scenarios form an essential basis for chemical risk assessment reports under the new EU chemicals regulation REACH (Registration, Evaluation, Authorisation and restriction of Chemicals). In case the dermal route of exposure is predominant, information on both exposure and dermal bioavailability is necessary for a proper risk assessment. Various methodologies exist to measure dermal exposure, providing quantitative or semiquantitative information. Although these studies may provide very specific and relevant information, it should be realized that case by case in-depth exposure assessment would be a very expensive process. Dermal bioavailability data are most often obtained from in vitro studies or animal experiments. For the design of studies, which generate data relevant for chemical risk assessment, detailed information on the exposure conditions is crucial (skin surface exposed, exposure duration, dose and physical state of the chemical). Results from non-testing methods for skin absorption, such as (Q)SARs, have been used only to a very limited extent for regulatory purposes. Suggestions are made in order to extend the use these methods to dermal risk assessment of chemical substances, thereby improving the practicability of REACH.
根据欧盟新的化学品法规REACH（化学品的注册、评估、授权和限制），暴露场景构成了化学品风险评估报告的重要基础。如果皮肤暴露途径占主导地位，那么对于恰当的风险评估而言，暴露信息和皮肤生物利用度信息都是必要的。存在多种测量皮肤暴露的方法，可提供定量或半定量信息。尽管这些研究可能会提供非常具体且相关的信息，但应该认识到，逐案进行深入的暴露评估将是一个非常昂贵的过程。皮肤生物利用度数据大多来自体外研究或动物实验。对于生成与化学品风险评估相关数据的研究设计而言，有关暴露条件的详细信息至关重要（皮肤暴露表面、暴露持续时间、剂量以及化学品的物理状态）。皮肤吸收的非测试方法（如（定量）构效关系）的结果在监管目的方面的应用非常有限。本文提出了一些建议，以便将这些方法的应用扩展到化学物质的皮肤风险评估中，从而提高REACH的实用性。
