Laboratory of Evironmental Chemistry and Toxicology, Department of Environmental Health Science, IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri," Via G. La Masa 19, Milan 20156, Italy.
Laboratory of Evironmental Chemistry and Toxicology, Department of Environmental Health Science, IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri," Via G. La Masa 19, Milan 20156, Italy.
Environ Int. 2014 Aug;69:40-50. doi: 10.1016/j.envint.2014.04.005. Epub 2014 May 4.
REACH (registration, evaluation, authorisation and restriction of chemicals) regulation requires that all the chemicals produced or imported in Europe above 1 tonne/year are registered. To register a chemical, physicochemical, toxicological and ecotoxicological information needs to be reported in a dossier. REACH promotes the use of alternative methods to replace, refine and reduce the use of animal (eco)toxicity testing. Within the EU OSIRIS project, integrated testing strategies (ITSs) have been developed for the rational use of non-animal testing approaches in chemical hazard assessment. Here we present an ITS for evaluating the bioaccumulation potential of organic chemicals. The scheme includes the use of all available data (also the non-optimal ones), waiving schemes, analysis of physicochemical properties related to the end point and alternative methods (both in silico and in vitro). In vivo methods are used only as last resort. Using the ITS, in vivo testing could be waived for about 67% of the examined compounds, but bioaccumulation potential could be estimated on the basis of non-animal methods. The presented ITS is freely available through a web tool.
REACH（化学品注册、评估、授权和限制）法规要求，在欧洲生产或进口的所有化学品，如果超过 1 吨/年，则必须进行注册。为了注册一种化学品，需要在一份档案中报告物理化学、毒理学和生态毒理学信息。REACH 提倡使用替代方法来替代、改进和减少动物（生态）毒性测试的使用。在欧盟 OSIRIS 项目中，已经为合理使用非动物测试方法在化学危害评估中开发了综合测试策略 (ITS)。在这里，我们提出了一种用于评估有机化学品生物累积潜力的 ITS。该方案包括使用所有可用的数据（包括非最佳数据）、豁免方案、分析与终点相关的物理化学性质以及替代方法（包括计算和体外方法）。体内方法仅作为最后的手段使用。使用该 ITS，大约 67%的受检化合物可以免除体内测试，但可以基于非动物方法估计生物累积潜力。该 ITS 可通过网络工具免费获得。
