Evidence map›Paper›PMID 32594184›Full record

GuidelineArchives of toxicology2020

Chemical carcinogen safety testing: OECD expert group international consensus on the development of an integrated approach for the testing and assessment of chemical non-genotoxic carcinogens.

Miriam N Jacobs, Annamaria Colacci, Raffaella Corvi, Monica Vaccari, M Cecilia Aguila, Marco Corvaro, Nathalie Delrue, Daniel Desaulniers, Norman Ertych, Abigail Jacobs and 8 more

Open access · hybridAbstract readConsensus StatementGuideline
In one paragraph

Guideline 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 48 papers.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed
6.1field-weighted citation impact, top 2% 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

48 citing papers in PubMed, 118 citations in OpenAlex.

  1. Article
  2. Article
  3. Rethinking the microenvironment's role in chemical-induced malignancy.Toxicological sciences : an official journal of the Society of Toxicology · 2026
    Review
  4. Safety Assessment ofJournal of toxicology · 2026
    Article
  5. Review
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  7. Review
  8. Review
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  10. Article
  11. Article
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  13. Review
  14. Article
  15. Article
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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

18 authors at 13 institutions in 10 countries.

Miriam N JacobsCentre for Radiation, Chemical and Environmental Hazards (CRCE), Public Health England, Chilton, UK. miriam.jacobs@phe.gov.uk.ORCID https://orcid.org/0000-0002-4858-0118
Annamaria ColacciCenter for Environment, Prevention and Health, Regional Agency for Prevention, Environment and Energy Emilia Romagna Region (Arpae), Bologna, Italy.
Raffaella CorviEuropean Commission Joint Research Centre (EC JRC), Ispra, Italy.
Monica VaccariCenter for Environment, Prevention and Health, Regional Agency for Prevention, Environment and Energy Emilia Romagna Region (Arpae), Bologna, Italy.
M Cecilia AguilaUS Food and Drug Administration (FDA), Silver Spring, MD, USA.
Marco CorvaroCorteva Agriscience, Abingdon, UK.ORCID https://orcid.org/0000-0002-3215-9820
Nathalie DelrueOrganisation for Economic Cooperation and Development (OECD), Paris, France.
Daniel DesaulniersHealth Canada, Ottawa, Canada.
Norman ErtychGerman Centre for the Protection of Laboratory Animals (Bf3R), German Federal Institute for Risk Assessment, Diedersdorfer Weg 1, 12277, Berlin, Germany.
Abigail JacobsUS Food and Drug Administration (FDA), Silver Spring, MD, USA.
Mirjam LuijtenNational Institute for Public Health and the Environment (RIVM), Bilthoven, Netherlands.ORCID https://orcid.org/0000-0002-5277-1443
Federica MadiaEuropean Commission Joint Research Centre (EC JRC), Ispra, Italy.ORCID https://orcid.org/0000-0002-8438-0957
Akiyoshi NishikawaNational Institute of Health Sciences, Kawasaki, Japan.
Kumiko OgawaNational Institute of Health Sciences, Kawasaki, Japan.
Kiyomi OhmoriKanagawa Prefectural Institute of Public Health, Chigasaki, Japan.
Martin PaparellaDivision of Medical Biochemistry, Biocenter, Medical University of Innsbruck, Innsbruck, Austria.
Anoop Kumar SharmaTechnical University of Denmark, Lyngby, Denmark.ORCID http://orcid.org/0000-0003-2491-4117
Paule VasseurCNRS University de Lorraine, Lorraine, France.
Agenzia Regionale Prevenzione e Ambiente della Regione Emilia-Romagna · ITJoint Research Centre · ITNational Institute of Health Sciences · JPUnited States Food and Drug Administration · USCentre National de la Recherche Scientifique · FRFederal Institute for Risk Assessment · DEHealth Canada · CAInnsbruck Medical University · ATKanagawa Prefectural Institute of Public Health · JPNational Institute for Public Health and the Environment · NLOrganisation de Coopération et de Développement Economiques · FRPublic Health England · GBTechnical University of Denmark · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

While regulatory requirements for carcinogenicity testing of chemicals vary according to product sector and regulatory jurisdiction, the standard approach starts with a battery of genotoxicity tests (which include mutagenicity assays). If any of the in vivo genotoxicity tests are positive, a lifetime rodent cancer bioassay may be requested, but under most chemical regulations (except plant protection, biocides, pharmaceuticals), this is rare. The decision to conduct further testing based on genotoxicity test outcomes creates a regulatory gap for the identification of non-genotoxic carcinogens (NGTxC). With the objective of addressing this gap, in 2016, the Organization of Economic Cooperation and Development (OECD) established an expert group to develop an integrated approach to the testing and assessment (IATA) of NGTxC. Through that work, a definition of NGTxC in a regulatory context was agreed. Using the adverse outcome pathway (AOP) concept, various cancer models were developed, and overarching mechanisms and modes of action were identified. After further refining and structuring with respect to the common hallmarks of cancer and knowing that NGTxC act through a large variety of specific mechanisms, with cell proliferation commonly being a unifying element, it became evident that a panel of tests covering multiple biological traits will be needed to populate the IATA. Consequently, in addition to literature and database investigation, the OECD opened a call for relevant assays in 2018 to receive suggestions. Here, we report on the definition of NGTxC, on the development of the overarching NGTxC IATA, and on the development of ranking parameters to evaluate the assays. Ultimately the intent is to select the best scoring assays for integration in an NGTxC IATA to better identify carcinogens and reduce public health hazards.

Indexed as

AnimalsCarcinogenicity TestsCarcinogensConsensusHumansReproducibility of ResultsRisk AssessmentCarcinogensCancer hallmarksCancer microenvironmentCancer modelCancer preventionHazard assessmentIATAIntegrated approaches to testing and assessmentNon-genotoxic carcinogenicity

Identifiers

PMID32594184
PMCPMC7395040
OpenAlexW3037446541

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.