Evidence map›Paper›PMID 32369604›Full record

ArticleALTEX2020

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

Costanza Rovida, Tara Barton-Maclaren, Emilio Benfenati, Francesca Caloni, P. Charukeshi Chandrasekera, Christophe Chesné, Mark T D Cronin, Joop De Knecht, Daniel R Dietrich, Sylvia E Escher and 21 more

Open access · goldAbstract read
In one paragraph

Article in ALTEX, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed
10.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 94 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Review
  11. Review
  12. Article
  13. Article
  14. Toxicology research · 2024
    Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

31 authors at 1 institution in 1 country.

Costanza RovidaCenter for Alternatives to Animal Testing, CAAT-Europe, University of Konstanz, Konstanz, Germany.
Tara Barton-MaclarenExisting Substances Risk Assessment Bureau, Health Canada, Ottawa, Canada.
Emilio BenfenatiLaboratory of Environmental Chemistry and Toxicology, Department of Environmental Health Sciences, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.
Francesca CaloniUniversità degli Studi di Milano, Department of Veterinary Medicine (DIMEVET) Milan, Italy.
P. Charukeshi ChandrasekeraCanadian Centre for Alternatives to Animal Methods, University of Windsor, Ontario, Canada
Christophe ChesnéBiopredic International, Saint Grégoire, France.
Mark T D CroninLiverpool John Moores University, School of Pharmacy and Biomolecular Sciences, Liverpool, UK.
Joop De KnechtCentre for Safety of Substances and Products, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
Daniel R DietrichHuman and Environmental Toxicology, University of Konstanz, Konstanz, Germany.
Sylvia E EscherFraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Hannover, Germany.
Suzanne FitzpatrickUS Food and Drug Administration, Center for Food Safety and Applied Nutrition, MD, USA.
Brenna FlanneryUS Food and Drug Administration, Center for Food Safety and Applied Nutrition, MD, USA.
Matthias HerzlerGerman Federal Institute for Risk Assessment (BfR), Berlin, Germany.
Susanne Hougaard BennekouDanish Environmental Protection Agency, Copenhagen, Denmark / Danish Technical University, FOOD, Lyngby, Denmark.
Bruno HubeschEuropean Chemical Industry Council (Cefic), Brussels, Belgium.
Hennicke KampExperimental Toxicology and Ecology, BASF SE, Ludwigshafen, Germany.
Jaffar KisituIn vitro Toxicology and Biomedicine, Dept inaugurated by the Doerenkamp-Zbinden Foundation, University of Konstanz, Konstanz, Germany.
Nicole KleinstreuerNTP 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 KovarichS-IN Soluzioni Informatiche S.r.l., Vicenza, Italy.
Marcel LeistCenter for Alternatives to Animal Testing, CAAT-Europe, University of Konstanz, Konstanz, Germany.
Alexandra MaertensCenter for Alternatives to Animal Testing (CAAT), Johns Hopkins University, Baltimore, MD, USA.
Kerry NugentAustralian Government Department of Health, Canberra, Australia.
Giorgia PalloccaCenter for Alternatives to Animal Testing, CAAT-Europe, University of Konstanz, Konstanz, Germany.
Manuel PastorResearch 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 PatlewiczCenter for Computational Toxicology & Exposure (CCTE), U.S. Environmental Protection Agency, Research Triangle Park, NC, USA.
Manuela PavanInnovatune S.r.l., Padova, Italy.
Octavio PresgraveDepartamento de Farmacologia e Toxicologia, Instituto Nacional de Controle da Qualidade em Saúde, Fundação Oswaldo Cruz (Fiocruz), Rio de Janeiro, Brazil.
Lena SmirnovaCenter for Alternatives to Animal Testing (CAAT), Johns Hopkins University, Baltimore, MD, USA.
Michael SchwarzUniversity of Tübingen, Tübingen, Germany.
Takashi YamadaNational Institute of Health Sciences, Kanagawa, Japan.
Thomas HartungCenter for Alternatives to Animal Testing, CAAT-Europe, University of Konstanz, Konstanz, Germany.
University of Konstanz · DE

Funding

Intramural EPA EPA999999
6 · The paper itself

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.

Indexed as

Computer SimulationReproducibility of ResultsRisk AssessmentAnimalsAnimal Testing AlternativesHazardous SubstancesHumansInternationalityToxicologyHazardous Substancesnew approach methodread-acrossregulatory toxicologyvalidation

Identifiers

PMID32369604
PMCPMC9201788
OpenAlexW3023925438

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.