Evidence map›Paper›PMID 32886186›Full record

ArticleArchives of toxicology2020

Setting the stage for next-generation risk assessment with non-animal approaches: the EU-ToxRisk project experience.

M J Moné, G Pallocca, S E Escher, T Exner, M Herzler, S Hougaard Bennekou, H Kamp, E D Kroese, Marcel Leist, T Steger-Hartmann and 1 more

Abstract readLetter
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 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing 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

25 citing papers in PubMed.

  1. Article
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  4. Multimodal Cross-Attentive Graph-Based Framework for Predicting In Vivo Endocrine Disruptors.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
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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

11 authors.

M J MonéLeiden Academic Centre for Drug Research, Leiden University, Leiden, The Netherlands.
G PalloccaCAAT-Europe at the University of Konstanz, Constance, Germany.ORCID 0000-0002-7358-1788
S E EscherFraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Hannover, Germany.
T ExnerEdelweiss Connect GmbH, Basel, Switzerland.
M HerzlerGerman Federal Institute for Risk Assessment (BfR), Berlin, Germany.
S Hougaard BennekouTechnical University of Denmark, Kongens Lyngby, Denmark.
H KampBASF SE, Ludwigshafen, Germany.
E D KroeseTNO Innovation for Life, Utrecht, The Netherlands.
Marcel LeistCAAT-Europe at the University of Konstanz, Constance, Germany. marcel.leist@uni-konstanz.de.
T Steger-HartmannInvestigational Toxicology, Bayer AG, Pharmaceuticals, Berlin, Germany.
B van de WaterLeiden Academic Centre for Drug Research, Leiden University, Leiden, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In 2016, the European Commission launched the EU-ToxRisk research project to develop and promote animal-free approaches in toxicology. The 36 partners of this consortium used in vitro and in silico methods in the context of case studies (CSs). These CSs included both compounds with a highly defined target (e.g. mitochondrial respiratory chain inhibitors) as well as compounds with poorly defined molecular initiation events (e.g. short-chain branched carboxylic acids). The initial project focus was on developing a science-based strategy for read-across (RAx) as an animal-free approach in chemical risk assessment. Moreover, seamless incorporation of new approach method (NAM) data into this process (= NAM-enhanced RAx) was explored. Here, the EU-ToxRisk consortium has collated its scientific and regulatory learnings from this particular project objective. For all CSs, a mechanistic hypothesis (in the form of an adverse outcome pathway) guided the safety evaluation. ADME data were generated from NAMs and used for comprehensive physiological-based kinetic modelling. Quality assurance and data management were optimized in parallel. Scientific and Regulatory Advisory Boards played a vital role in assessing the practical applicability of the new approaches. In a next step, external stakeholders evaluated the usefulness of NAMs in the context of RAx CSs for regulatory acceptance. For instance, the CSs were included in the OECD CS portfolio for the Integrated Approach to Testing and Assessment project. Feedback from regulators and other stakeholders was collected at several stages. Future chemical safety science projects can draw from this experience to implement systems toxicology-guided, animal-free next-generation risk assessment.

Indexed as

Adverse Outcome PathwaysAnimalsAnimal Testing AlternativesBiomedical ResearchComputer SimulationHumansIn Vitro TechniquesRisk AssessmentToxicology

Identifiers

PMID32886186
PMCPMC7502065

What OpenQuestion holds

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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.