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

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2020
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Barton-Maclaren, Tara
Benfenati, Emilio
Caloni, Francesca
Chandrasekera, Charu
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EUToxRisk21
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Alternatives to Animal Experimentation : ALTEX. Springer Spektrum. 2020, 37(4), pp. 579-606. ISSN 1868-596X. eISSN 1868-8551. Available under: doi: 10.14573/altex.1912181
Zusammenfassung

Read-across (RAx) translates available information from well-characterized chemicals to the 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 optimisation 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.

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570 Biowissenschaften, Biologie
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ISO 690ROVIDA, Costanza, Tara BARTON-MACLAREN, Emilio BENFENATI, Francesca CALONI, Charu CHANDRASEKERA, Daniel R. DIETRICH, Jaffar KISITU, Marcel LEIST, Giorgia PALLOCCA, Thomas HARTUNG, 2020. Internationalization of read-across as a validated new approach method (NAM) for regulatory toxicology. In: Alternatives to Animal Experimentation : ALTEX. Springer Spektrum. 2020, 37(4), pp. 579-606. ISSN 1868-596X. eISSN 1868-8551. Available under: doi: 10.14573/altex.1912181
BibTex
@article{Rovida2020Inter-49443,
  year={2020},
  doi={10.14573/altex.1912181},
  title={Internationalization of read-across as a validated new approach method (NAM) for regulatory toxicology},
  number={4},
  volume={37},
  issn={1868-596X},
  journal={Alternatives to Animal Experimentation : ALTEX},
  pages={579--606},
  author={Rovida, Costanza and Barton-Maclaren, Tara and Benfenati, Emilio and Caloni, Francesca and Chandrasekera, Charu and Dietrich, Daniel R. and Kisitu, Jaffar and Leist, Marcel and Pallocca, Giorgia and Hartung, Thomas}
}
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