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

Authors

  • Costanza Rovida Center for Alternatives to Animal Testing, CAAT-Europe, University of Konstanz, Konstanz, Germany
  • Tara Barton-Maclaren Existing Substances Risk Assessment Bureau, Health Canada, Ottawa, Canada
  • Emilio Benfenati Laboratory of Environmental Chemistry and Toxicology, Department of Environmental Health Sciences, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy
  • Francesca Caloni Università degli Studi di Milano, Department of Veterinary Medicine (DIMEVET) Milan, Italy
  • P. Charukeshi Chandrasekera Canadian Centre for Alternatives to Animal Methods, University of Windsor, Ontario, Canada
  • Christophe Chesné Biopredic International, Saint Grégoire, France
  • Mark T. D. Cronin Liverpool John Moores University, School of Pharmacy and Biomolecular Sciences, Liverpool, UK
  • Joop De Knecht Centre for Safety of Substances and Products, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands
  • Daniel R. Dietrich Human and Environmental Toxicology, University of Konstanz, Konstanz, Germany
  • Sylvia E. Escher Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Hannover, Germany
  • Suzanne Fitzpatrick US Food and Drug Administration, Center for Food Safety and Applied Nutrition, MD, USA
  • Brenna Flannery US Food and Drug Administration, Center for Food Safety and Applied Nutrition, MD, USA
  • Matthias Herzler German Federal Institute for Risk Assessment (BfR), Berlin, Germany
  • Susanne Hougaard Bennekou Danish Environmental Protection Agency, Copenhagen, Denmark / Danish Technical University, FOOD, Lyngby, Denmark
  • Bruno Hubesch European Chemical Industry Council (Cefic), Brussels, Belgium
  • Hennicke Kamp Experimental Toxicology and Ecology, BASF SE, Ludwigshafen, Germany
  • Jaffar Kisitu In vitro Toxicology and Biomedicine, Dept inaugurated by the Doerenkamp-Zbinden Foundation, University of Konstanz, Konstanz, Germany
  • Nicole Kleinstreuer NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, NC, United States
  • Simona Kovarich S-IN Soluzioni Informatiche S.r.l., Vicenza, Italy
  • Marcel Leist Center for Alternatives to Animal Testing, CAAT-Europe, University of Konstanz, Konstanz, Germany; In vitro Toxicology and Biomedicine, Dept inaugurated by the Doerenkamp-Zbinden Foundation, University of Konstanz, Konstanz, Germany http://orcid.org/0000-0002-3778-8693 (unauthenticated)
  • Alexandra Maertens Center for Alternatives to Animal Testing (CAAT), Johns Hopkins University, Baltimore, MD, USA
  • Kerry Nugent Australian Government Department of Health, Canberra, Australia
  • Giorgia Pallocca Center for Alternatives to Animal Testing, CAAT-Europe, University of Konstanz, Konstanz, Germany
  • Manuel Pastor Research Programme on Biomedical Informatics (GRIB), Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Dept. of Experimental and Health Sciences, Universitat Pompeu Fabra, Barcelona, Spain
  • Grace Patlewicz Center for Computational Toxicology & Exposure (CCTE), U.S. Environmental Protection Agency, Research Triangle Park, NC, USA;
  • Manuela Pavan Innovatune S.r.l., Padova, Italy
  • Octavio Presgrave Departamento de Farmacologia e Toxicologia, Instituto Nacional de Controle da Qualidade em Saúde, Fundação Oswaldo Cruz (Fiocruz), Rio de Janeiro, Brazil
  • Lena Smirnova Center for Alternatives to Animal Testing (CAAT), Johns Hopkins University, Baltimore, MD, USA
  • Michael Schwarz University of Tübingen, Tübingen, Germany
  • Takashi Yamada National Institute of Health Sciences, Kanagawa, Japan
  • Thomas Hartung Center for Alternatives to Animal Testing, CAAT-Europe, University of Konstanz, Konstanz, Germany; Center for Alternatives to Animal Testing (CAAT), Johns Hopkins University, Baltimore, MD, USA http://orcid.org/0000-0003-1359-7689 (unauthenticated)

DOI:

https://doi.org/10.14573/altex.1912181

Keywords:

regulatory toxicology, new approach method, validation, read-across

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.

BERJAYA

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Published

2020-10-20

Issue

Vol. 37 No. 4 (2020)

Section

Articles

License

Copyright (c) 2020 Costanza Rovida, Tara Barton-Maclaren, Emilio Benfenati, Francesca Caloni, P. Charukeshi Chandrasekera, Christophe Chesne, Mark T. D. Cronin, Joop De Knecht, Daniel R. Dietrich, Sylvia E. Escher, Suzanne Fitzpatrick, Brenna Flannery, Matthias Herzler, Susanne Hougaard Bennekou, Bruno Hubesch, Hennicke Kamp, Jaffar Kisitu, Nicole Kleinstreuer, Simona Kovarich, Marcel Leist, Alexandra Maertens, Kerry Nugent, Giorgia Pallocca, Manuel Pastor, Grace Patlewicz, Manuela Pavan, Octavio Presgrave, Lena Smirnova, Michael Schwarz, Takashi Yamada, Thomas Hartung

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Articles are 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 (CC-BY). Copyright on any article in ALTEX is retained by the author(s).

How to Cite

Rovida, C., Barton-Maclaren, T., Benfenati, E., Caloni, F., Chandrasekera, P. C., Chesné, C., Cronin, M. T. D., De Knecht, J., Dietrich, D. R., Escher, S. E., Fitzpatrick, S., Flannery, B., Herzler, M., Hougaard Bennekou, S., Hubesch, B., Kamp, H., Kisitu, J., Kleinstreuer, N., Kovarich, S., … Hartung, T. (2020). Internationalization of read-across as a validated new approach method (NAM) for regulatory toxicology. ALTEX - Alternatives to Animal Experimentation, 37(4), 579-606. https://doi.org/10.14573/altex.1912181

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