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The EU-ToxRisk method documentation, data processing and chemical testing pipeline for the regulatory use of new approach methods

The EU-ToxRisk method documentation, data processing and chemical testing pipeline for the regulatory use of new approach methods

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KREBS, Alice, Barbara M. A. VAN VUGT-LUSSENBURG, Tanja WALDMANN, Francois BUSQUET, Xenia DOLDE, Anna-Katharina HOLZER, Jaffar KISITU, Giorgia PALLOCCA, Costanza ROVIDA, Marcel LEIST, 2020. The EU-ToxRisk method documentation, data processing and chemical testing pipeline for the regulatory use of new approach methods. In: Archives of Toxicology. Springer. 94(7), pp. 2435-2461. ISSN 0340-5761. eISSN 1432-0738. Available under: doi: 10.1007/s00204-020-02802-6

@article{Krebs2020-07EUTox-50516, title={The EU-ToxRisk method documentation, data processing and chemical testing pipeline for the regulatory use of new approach methods}, year={2020}, doi={10.1007/s00204-020-02802-6}, number={7}, volume={94}, issn={0340-5761}, journal={Archives of Toxicology}, pages={2435--2461}, author={Krebs, Alice and van Vugt-Lussenburg, Barbara M. A. and Waldmann, Tanja and Busquet, Francois and Dolde, Xenia and Holzer, Anna-Katharina and Kisitu, Jaffar and Pallocca, Giorgia and Rovida, Costanza and Leist, Marcel} }

2020-07 Pallocca, Giorgia Rovida, Costanza The EU-ToxRisk method documentation, data processing and chemical testing pipeline for the regulatory use of new approach methods Dolde, Xenia Holzer, Anna-Katharina 2020-08-17T11:28:17Z Waldmann, Tanja 2020-08-17T11:28:17Z eng Attribution 4.0 International Krebs, Alice van Vugt-Lussenburg, Barbara M. A. Busquet, Francois Leist, Marcel van Vugt-Lussenburg, Barbara M. A. Pallocca, Giorgia Kisitu, Jaffar Dolde, Xenia Leist, Marcel Kisitu, Jaffar Rovida, Costanza Waldmann, Tanja Holzer, Anna-Katharina Krebs, Alice Hazard assessment, based on new approach methods (NAM), requires the use of batteries of assays, where individual tests may be contributed by different laboratories. A unified strategy for such collaborative testing is presented. It details all procedures required to allow test information to be usable for integrated hazard assessment, strategic project decisions and/or for regulatory purposes. The EU-ToxRisk project developed a strategy to provide regulatorily valid data, and exemplified this using a panel of > 20 assays (with > 50 individual endpoints), each exposed to 19 well-known test compounds (e.g. rotenone, colchicine, mercury, paracetamol, rifampicine, paraquat, taxol). Examples of strategy implementation are provided for all aspects required to ensure data validity: (i) documentation of test methods in a publicly accessible database; (ii) deposition of standard operating procedures (SOP) at the European Union DB-ALM repository; (iii) test readiness scoring accoding to defined criteria; (iv) disclosure of the pipeline for data processing; (v) link of uncertainty measures and metadata to the data; (vi) definition of test chemicals, their handling and their behavior in test media; (vii) specification of the test purpose and overall evaluation plans. Moreover, data generation was exemplified by providing results from 25 reporter assays. A complete evaluation of the entire test battery will be described elsewhere. A major learning from the retrospective analysis of this large testing project was the need for thorough definitions of the above strategy aspects, ideally in form of a study pre-registration, to allow adequate interpretation of the data and to ensure overall scientific/toxicological validity. Busquet, Francois

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