New ideas for non-animal approaches to predict repeated-dose systemic toxicity: Report from an EPAA Blue Sky Workshop.

Alternatives Chemical legislation Read-across Repeated dose toxicity testing Safety assessment ab initio in silico in vitro

Journal

Regulatory toxicology and pharmacology : RTP
ISSN: 1096-0295
Titre abrégé: Regul Toxicol Pharmacol
Pays: Netherlands
ID NLM: 8214983

Informations de publication

Date de publication:
Jul 2020
Historique:
received: 27 03 2020
revised: 10 04 2020
accepted: 17 04 2020
pubmed: 27 4 2020
medline: 24 2 2021
entrez: 27 4 2020
Statut: ppublish

Résumé

The European Partnership for Alternative Approaches to Animal Testing (EPAA) convened a 'Blue Sky Workshop' on new ideas for non-animal approaches to predict repeated-dose systemic toxicity. The aim of the Workshop was to formulate strategic ideas to improve and increase the applicability, implementation and acceptance of modern non-animal methods to determine systemic toxicity. The Workshop concluded that good progress is being made to assess repeated dose toxicity without animals taking advantage of existing knowledge in toxicology, thresholds of toxicological concern, adverse outcome pathways and read-across workflows. These approaches can be supported by New Approach Methodologies (NAMs) utilising modern molecular technologies and computational methods. Recommendations from the Workshop were based around the needs for better chemical safety assessment: how to strengthen the evidence base for decision making; to develop, standardise and harmonise NAMs for human toxicity; and the improvement in the applicability and acceptance of novel techniques. "Disruptive thinking" is required to reconsider chemical legislation, validation of NAMs and the opportunities to move away from reliance on animal tests. Case study practices and data sharing, ensuring reproducibility of NAMs, were viewed as crucial to the improvement of non-animal test approaches for systemic toxicity.

Identifiants

pubmed: 32335207
pii: S0273-2300(20)30094-5
doi: 10.1016/j.yrtph.2020.104668
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

104668

Informations de copyright

Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Some of the authors received reimbursement of their travel expenses by the EPAA to make their participation in the workshop possible. If deemed necessary, a list of those people who received travel expenses support can be provided.

Auteurs

Catherine Mahony (C)

Procter & Gamble, Egham, Surrey, UK. Electronic address: mahony.c@pg.com.

Randolph S Ashton (RS)

Department of Biomedical Engineering & Wisconsin Institute for Discovery, University of Wisconsin-Madison, Madison, 53715, USA. Electronic address: rashton2@wisc.edu.

Barbara Birk (B)

BASF SE, Experimental Toxicology and Ecology, Carl-Bosch-Straβe 38, 67056, Ludwigshafen, Germany. Electronic address: barbara.birk@basf.com.

Alan R Boobis (AR)

National Heart & Lung Institute, Imperial College London, London, W12 0NN, UK. Electronic address: a.boobis@imperial.ac.uk.

Tom Cull (T)

Unilever, Colworth Science Park, Sharnbrook, Bedford, MK44 1LQ, UK. Electronic address: tom.cull@unilever.com.

George P Daston (GP)

Mason Business Center, The Procter & Gamble Company, Cincinnati, OH, 45040, USA. Electronic address: daston.gp@pg.com.

Lorna Ewart (L)

Veroli Consulting Limited, Cambridge, UK; Emulate Inc, 27 Dry Dock Avenue, Boston, MA, 02210, USA. Electronic address: lorna.ewart@emulatebio.com.

Thomas B Knudsen (TB)

U.S. Environmental Protection Agency, Office of Research and Development, Center for Computational Toxicology and Exposure, Research Triangle Park, NC, 27711, USA. Electronic address: knudsen.thomas@epa.gov.

Irene Manou (I)

European Partnership for Alternative Approaches to Animal Testing (EPAA) Industry Secretariat, Belgium. Electronic address: irene.manou@epaaind.eu.

Sebastian Maurer-Stroh (S)

Innovations in Chemical and Food Safety, Bioinformatics Institute, Agency for Science, Technology and Research (A*STAR), 30 Biopolis Street #07-01 Matrix, Singapore, 138671, Singapore; Department of Biological Sciences, National University of Singapore, 14 Science Drive 4, Singapore, 117543, Singapore. Electronic address: sebastianms@bii.a-star.edu.sg.

Luigi Margiotta-Casaluci (L)

College of Health and Life Sciences, Brunel University London, London, UB8 3PH, UK. Electronic address: luigi.margiotta-casaluci@brunel.ac.uk.

Boris P Müller (BP)

Symrise AG, Holzminden, Germany. Electronic address: boris.mueller@symrise.com.

Pär Nordlund (P)

Department of Oncology and Pathology, Karolinska Institutet, 17177, Stockholm, Sweden; Institute of Molecular and Cellular Biology, A*STAR, 61 Biopolis Drive, 138673, Singapore. Electronic address: par.nordlund@ki.se.

Ruth A Roberts (RA)

School of Chemistry, University of Birmingham, Birmingham, B15 2TT, UK. Electronic address: r.roberts.4@bham.ac.uk.

Thomas Steger-Hartmann (T)

Investigational Toxicology, Bayer AG, Pharmaceuticals, Müllerstraβe 178, 13353, Berlin, Germany. Electronic address: thomas.steger-hartmann@bayer.com.

Evita Vandenbossche (E)

Unilever, Colworth Science Park, Sharnbrook, Bedford, MK44 1LQ, UK. Electronic address: evita.vandenbossche@unilever.com.

Mark R Viant (MR)

School of Biosciences, University of Birmingham, Birmingham, B15 2TT, UK. Electronic address: m.viant@bham.ac.uk.

Mathieu Vinken (M)

Department of In Vitro Toxicology and Dermato-Cosmetology, Vrije Universiteit Brussel, Laarbeeklaan 103, 1090, Brussels, Belgium. Electronic address: mathieu.vinken@vub.be.

Maurice Whelan (M)

European Commission, Joint Research Centre (JRC), Italy. Electronic address: maurice.whelan@ec.europa.eu.

Zvonar Zvonimir (Z)

European Partnership for Alternative Approaches to Animal Testing (EPAA) Industry Secretariat, Belgium. Electronic address: zvonimir.zvonar@epaaind.eu.

Mark T D Cronin (MTD)

School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Byrom Street, Liverpool, L3 3AF, UK. Electronic address: m.t.cronin@ljmu.ac.uk.

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