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

Mostra el registre complet Registre parcial de l'ítem

• dc.contributor.author Krebs, Alice
• dc.contributor.author Pastor Maeso, Manuel
• dc.contributor.author Leist, Marcel
• dc.date.accessioned 2020-09-15T06:27:02Z
• dc.date.available 2020-09-15T06:27:02Z
• dc.date.issued 2020
• dc.description.abstract 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.
• dc.description.sponsorship This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 681002.
• dc.format.mimetype application/pdf
• dc.identifier.citation Krebs A, van Vugt-Lussenburg BMA, Waldmann T, Albrecht W, Boei J, Ter Braak B et al. The EU-ToxRisk method documentation, data processing and chemical testing pipeline for the regulatory use of new approach methods. Arch Toxicol. 2020; 94(7):2435-61. DOI: 10.1007/s00204-020-02802-6
• dc.identifier.doi http://dx.doi.org/10.1007/s00204-020-02802-6
• dc.identifier.issn 0340-5761
• dc.identifier.uri http://hdl.handle.net/10230/45283
• dc.language.iso eng
• dc.publisher Springer
• dc.relation.ispartof Arch Toxicol. 2020; 94(7):2435-61
• dc.relation.projectID info:eu-repo/grantAgreement/EC/H2020/681002
• dc.rights © The Author(s) 2020. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by/4.0/
• dc.subject.keyword Data processing
• dc.subject.keyword GIVIMP
• dc.subject.keyword In vitro toxicology
• dc.subject.keyword Metadata
• dc.subject.keyword Nuclear receptor
• dc.title The EU-ToxRisk method documentation, data processing and chemical testing pipeline for the regulatory use of new approach methods
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion