Evidence map›Paper›PMID 32632539›Full record

ArticleArchives of toxicology2020

The EU-ToxRisk method documentation, data processing and chemical testing pipeline for the regulatory use of new approach methods.

Alice Krebs, Barbara M A van Vugt-Lussenburg, Tanja Waldmann, Wiebke Albrecht, Jan Boei, Bas Ter Braak, Maja Brajnik, Thomas Braunbeck, Tim Brecklinghaus, Francois Busquet and 35 more

Abstract read
In one paragraph

Article in Archives of toxicology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
–field-weighted citation impact
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

22 citing papers in PubMed.

  1. Systematic comparison of temporal hepatotoxicant-induced gene network responses across 3 liver test systems.Toxicological sciences : an official journal of the Society of Toxicology · 2026
    Article
  2. Article
  3. Article
  4. What's in a NAM?Lab animal · 2026
    Review
  5. Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
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  15. Article
  16. Principles and Procedures for Assessment of Acute Toxicity IncorporatingComputational toxicology (Amsterdam, Netherlands) · 2022
    Article
  17. Article
  18. Article
  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

45 authors.

Alice KrebsIn Vitro Toxicology and Biomedicine, Department Inaugurated by the Doerenkamp-Zbinden Foundation, University of Konstanz, Universitaetsstr. 10, 78457, Konstanz, Germany.ORCID 0000-0002-0276-4747
Barbara M A van Vugt-LussenburgBioDetection Systems BV, Science Park 406, 1098 XH, Amsterdam, The Netherlands.
Tanja WaldmannIn Vitro Toxicology and Biomedicine, Department Inaugurated by the Doerenkamp-Zbinden Foundation, University of Konstanz, Universitaetsstr. 10, 78457, Konstanz, Germany.
Wiebke AlbrechtLeibniz-Institut für Arbeitsforschung an der TU Dortmund, Leibniz Research Center for Working Environment and Human Factors (IfADo), Ardeystraße 67, 44139, Dortmund, Germany.
Jan BoeiLeiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.
Bas Ter BraakDivision of Drug Discovery and Safety, Leiden Academic Center for Drug Research, Leiden University, Einsteinweg 55, 2333 CC, Leiden, The Netherlands.
Maja BrajnikEdelweiss Connect GmbH, Technology Park Basel, Hochbergerstrasse 60C, 4057, Basel, Switzerland.
Thomas BraunbeckAquatic Ecology and Toxicology Group, Center for Organismal Studies, University of Heidelberg, Im Neuenheimer Feld 504, 69120, Heidelberg, Germany.
Tim BrecklinghausLeibniz-Institut für Arbeitsforschung an der TU Dortmund, Leibniz Research Center for Working Environment and Human Factors (IfADo), Ardeystraße 67, 44139, Dortmund, Germany.
Francois BusquetCAAT Europe, University of Konstanz, Steinbeis SU-1866, 78457, Konstanz, Germany.
Andras DinnyesBioTalentum Ltd., Aulich Lajos str. 26, Gödöllő, 2100, Hungary.
Joh DoklerEdelweiss Connect GmbH, Technology Park Basel, Hochbergerstrasse 60C, 4057, Basel, Switzerland.
Xenia DoldeIn Vitro Toxicology and Biomedicine, Department Inaugurated by the Doerenkamp-Zbinden Foundation, University of Konstanz, Universitaetsstr. 10, 78457, Konstanz, Germany.
Thomas E ExnerEdelweiss Connect GmbH, Technology Park Basel, Hochbergerstrasse 60C, 4057, Basel, Switzerland.
Ciarán FisherSimcyp Division, Certara UK Limited, Level 2-Acero, 1 Concourse Way, Sheffield, S1 2BJ, UK.
David FluriInSphero AG, Wagistrasse 27, 8952, Schlieren, Switzerland.
Anna ForsbyUnit of Toxicology Sciences, Swedish Toxicology Sciences Research Center (Swetox), Karolinska Institutet, Forskargatan 20, 151 36, Södertälje, Sweden.
Jan G HengstlerLeibniz-Institut für Arbeitsforschung an der TU Dortmund, Leibniz Research Center for Working Environment and Human Factors (IfADo), Ardeystraße 67, 44139, Dortmund, Germany.
Anna-Katharina HolzerIn Vitro Toxicology and Biomedicine, Department Inaugurated by the Doerenkamp-Zbinden Foundation, University of Konstanz, Universitaetsstr. 10, 78457, Konstanz, Germany.
Zofia JanstovaBioTalentum Ltd., Aulich Lajos str. 26, Gödöllő, 2100, Hungary.
Paul JenningsDivision of Molecular and Computational Toxicology, Department of Chemistry and Pharmaceutical Sciences, Vrije Universiteit Amsterdam, De Boelelaan 1108, 1081 HZ, Amsterdam, The Netherlands.
Jaffar KisituIn Vitro Toxicology and Biomedicine, Department Inaugurated by the Doerenkamp-Zbinden Foundation, University of Konstanz, Universitaetsstr. 10, 78457, Konstanz, Germany.
Julianna KobolakBioTalentum Ltd., Aulich Lajos str. 26, Gödöllő, 2100, Hungary.
Manoj KumarDepartment of Development and Regeneration, Stem Cell Biology and Embryology, Stem Cell Institute Leuven, KU Leuven, O&N IV Herestraat 49, 3000, Leuven, Belgium.
Alice LimoncielDivision of Molecular and Computational Toxicology, Department of Chemistry and Pharmaceutical Sciences, Vrije Universiteit Amsterdam, De Boelelaan 1108, 1081 HZ, Amsterdam, The Netherlands.
Jessica LundqvistUnit of Toxicology Sciences, Swedish Toxicology Sciences Research Center (Swetox), Karolinska Institutet, Forskargatan 20, 151 36, Södertälje, Sweden.
Balázs MihalikBioTalentum Ltd., Aulich Lajos str. 26, Gödöllő, 2100, Hungary.
Wolfgang MoritzInSphero AG, Wagistrasse 27, 8952, Schlieren, Switzerland.
Giorgia PalloccaCAAT Europe, University of Konstanz, Steinbeis SU-1866, 78457, Konstanz, Germany.
Andrea Paola Cediel UlloaUnit of Toxicology Sciences, Swedish Toxicology Sciences Research Center (Swetox), Karolinska Institutet, Forskargatan 20, 151 36, Södertälje, Sweden.
Manuel PastorDepartment of Experimental and Health Sciences, Research Programme on Biomedical Informatics (GRIB), Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Universitat Pompeu Fabra, 08003, Barcelona, Spain.
Costanza RovidaCAAT Europe, University of Konstanz, Steinbeis SU-1866, 78457, Konstanz, Germany.
Ugis SarkansEuropean Molecular Biology Laboratory, European Bioinformatics Institute (EMBL-EBI), Wellcome Genome Campus, Cambridge, UK.
Johannes P SchimmingLeiden Academic Center for Drug Research, LACDR/Toxicology, Leiden University, PO Box 9500, 2300 RA, Leiden, The Netherlands.
Bela Z SchmidtSwitch Laboratory, Department of Cellular and Molecular Medicine, VIB-KU Leuven Center for Brain and Disease Research, KU Leuven, Herestraat 49, 3000, Leuven, Belgium.
Regina StöberLeibniz-Institut für Arbeitsforschung an der TU Dortmund, Leibniz Research Center for Working Environment and Human Factors (IfADo), Ardeystraße 67, 44139, Dortmund, Germany.
Tobias StrassfeldInSphero AG, Wagistrasse 27, 8952, Schlieren, Switzerland.
Bob van de WaterLeiden Academic Center for Drug Research, LACDR/Toxicology, Leiden University, PO Box 9500, 2300 RA, Leiden, The Netherlands.
Anja WilmesDivision of Molecular and Computational Toxicology, Department of Chemistry and Pharmaceutical Sciences, Vrije Universiteit Amsterdam, De Boelelaan 1108, 1081 HZ, Amsterdam, The Netherlands.
Bart van der BurgBioDetection Systems BV, Science Park 406, 1098 XH, Amsterdam, The Netherlands.
Catherine M VerfaillieDepartment of Development and Regeneration, Stem Cell Biology and Embryology, Stem Cell Institute Leuven, KU Leuven, O&N IV Herestraat 49, 3000, Leuven, Belgium.
Rebecca von HellfeldAquatic Ecology and Toxicology Group, Center for Organismal Studies, University of Heidelberg, Im Neuenheimer Feld 504, 69120, Heidelberg, Germany.
Harry VrielingLeiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.
Nanette G VrijenhoekLeiden Academic Center for Drug Research, LACDR/Toxicology, Leiden University, PO Box 9500, 2300 RA, Leiden, The Netherlands.
Marcel LeistIn Vitro Toxicology and Biomedicine, Department Inaugurated by the Doerenkamp-Zbinden Foundation, University of Konstanz, Universitaetsstr. 10, 78457, Konstanz, Germany. marcel.leist@uni-konstanz.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Hazard assessment, based on new approach methods (NAM), requires the use of batteries of assays, where individual tests may be contributed by different laboratories. A unified strategy for such collaborative testing is presented. It details all procedures required to allow test information to be usable for integrated hazard assessment, strategic project decisions and/or for regulatory purposes. The EU-ToxRisk project developed a strategy to provide regulatorily valid data, and exemplified this using a panel of > 20 assays (with > 50 individual endpoints), each exposed to 19 well-known test compounds (e.g. rotenone, colchicine, mercury, paracetamol, rifampicine, paraquat, taxol). Examples of strategy implementation are provided for all aspects required to ensure data validity: (i) documentation of test methods in a publicly accessible database; (ii) deposition of standard operating procedures (SOP) at the European Union DB-ALM repository; (iii) test readiness scoring accoding to defined criteria; (iv) disclosure of the pipeline for data processing; (v) link of uncertainty measures and metadata to the data; (vi) definition of test chemicals, their handling and their behavior in test media; (vii) specification of the test purpose and overall evaluation plans. Moreover, data generation was exemplified by providing results from 25 reporter assays. A complete evaluation of the entire test battery will be described elsewhere. A major learning from the retrospective analysis of this large testing project was the need for thorough definitions of the above strategy aspects, ideally in form of a study pre-registration, to allow adequate interpretation of the data and to ensure overall scientific/toxicological validity.

Indexed as

DocumentationGovernment RegulationToxicity TestsAnimalsCells, CulturedElectronic Data ProcessingEuropeHumansPolicy MakingReproducibility of ResultsRetrospective StudiesRisk AssessmentTerminology as TopicToxicologyZebrafishData processingGIVIMPIn vitro toxicologyMetadataNuclear receptor

Identifiers

PMID32632539
PMCPMC7367925

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.