Internationalization of read-across as a validated new approach method (NAM) for regulatory toxicology

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• dc.contributor.author Rovida, Costanza
• dc.contributor.author Pastor Maeso, Manuel
• dc.contributor.author Hartung, Thomas
• dc.date.accessioned 2020-11-18T07:50:55Z
• dc.date.available 2020-11-18T07:50:55Z
• dc.date.issued 2020
• dc.description.abstract Read-across (RAx) translates available information from well-characterized chemicals to a substance for which there is a toxicological data gap. The OECD is working on case studies to probe general applicability of RAx, and several regulations (e.g., EU-REACH) already allow this procedure to be used to waive new in vivo tests. The decision to prepare a review on the state of the art of RAx as a tool for risk assessment for regulatory purposes was taken during a workshop with international experts in Ranco, Italy in July 2018. Three major issues were identified that need optimization to allow a higher regulatory acceptance rate of the RAx procedure: (i) the definition of similarity of source and target, (ii) the translation of biological/toxicological activity of source to target in the RAx procedure, and (iii) how to deal with issues of ADME that may differ between source and target. The use of new approach methodologies (NAM) was discussed as one of the most important innovations to improve the acceptability of RAx. At present, NAM data may be used to confirm chemical and toxicological similarity. In the future, the use of NAM may be broadened to fully characterize the hazard and toxicokinetic properties of RAx compounds. Concerning available guidance, documents on Good Read-Across Practice (GRAP) and on best practices to perform and evaluate the RAx process were identified. Here, in particular, the RAx guidance, being worked out by the European Commission’s H2020 project EU-ToxRisk together with many external partners with regulatory experience, is given.
• dc.format.mimetype application/pdf
• dc.identifier.citation Rovida C, Barton-Maclaren T, Benfenati E, Caloni F, Chandrasekera PC, Chesné C. et al. Internationalization of read-across as a validated new approach method (NAM) for regulatory toxicology. ALTEX. 2020; 37(4):579-606. DOI: 10.14573/altex.1912181
• dc.identifier.doi http://dx.doi.org/10.14573/altex.1912181
• dc.identifier.issn 1868-596X
• dc.identifier.uri http://hdl.handle.net/10230/45798
• dc.language.iso eng
• dc.publisher ALTEX
• dc.relation.ispartof ALTEX. 2020;37(4):579-606
• dc.rights This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 International license (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium, provided the original work is appropriately cited
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by/4.0/
• dc.subject.keyword New approach method
• dc.subject.keyword Read-across
• dc.subject.keyword Regulatory toxicology
• dc.subject.keyword Validation
• dc.title Internationalization of read-across as a validated new approach method (NAM) for regulatory toxicology
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion