Evidence map›Paper›PMID 36309218›Full record

ReviewEnvironmental research2023

Application of AOPs to assist regulatory assessment of chemical risks - Case studies, needs and recommendations.

Lola Bajard, Ondrej Adamovsky, Karine Audouze, Kirsten Baken, Robert Barouki, Joost B Beltman, Anna Beronius, Eva Cecilie Bonefeld-Jørgensen, German Cano-Sancho, Milo L de Baat and 25 more

Abstract readReview
In one paragraph

Review in Environmental research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
–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

26 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  19. Guardians under Siege: Exploring Pollution's Effects on Human Immunity.International journal of molecular sciences · 2024
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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

35 authors.

Lola BajardRECETOX, Faculty of Science, Masaryk University, Kotlarska 2, 611 37 Brno, Czech Republic.
Ondrej AdamovskyRECETOX, Faculty of Science, Masaryk University, Kotlarska 2, 611 37 Brno, Czech Republic.
Karine AudouzeUniversité Paris Cité, T3S, Inserm UMR S-1124, F-75006 Paris, France.
Kirsten BakenUnit Health, Flemish Institute for Technological Research (VITO NV), Boeretang 200, 2400 Mol, Belgium.
Robert BaroukiUniversité Paris Cité, T3S, Inserm UMR S-1124, F-75006 Paris, France.
Joost B BeltmanDivision of Drug Discovery and Safety, Leiden Academic Centre for Drug Research, Leiden University, Leiden, Netherlands.
Anna BeroniusInstitute of Environmental Medicine, Karolinska Institutet, Nobels väg 13, Solna, Sweden.
Eva Cecilie Bonefeld-JørgensenCentre for Arctic Health & Molecular Epidemiology, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000 Aarhus, Denmark; Greenland Centre for Health Research, University of Greenland, Manutooq 1, 3905 Nuussuaq, Greenland.
German Cano-SanchoLABERCA, Oniris, INRAE, Nantes, France.
Milo L de BaatKWR Water Research Institute, Groningenhaven 7, 3433 PE Nieuwegein, the Netherlands.
Filippo Di TillioDivision of Drug Discovery and Safety, Leiden Academic Centre for Drug Research, Leiden University, Leiden, Netherlands.
Mariana F FernándezCenter for Biomedical Research (CIBM) & School of Medicine, University of Granada, 18016 Granada, Spain; Instituto de Investigación Biosanitaria (ibs. GRANADA), 18012, Granada, Spain; Consortium for Biomedical Research in Epidemiology and Public Health (CIBERESP), 28029 Madrid, Spain.
Rex E FitzGeraldSwiss Centre for Applied Human Toxicology SCAHT, University of Basel, Missionsstrasse 64, CH-4055 Basel, Switzerland.
Claudia GundackerInstitute of Medical Genetics, Center for Pathobiochemistry and Genetics, Medical University of Vienna, 1090 Vienna, Austria.
Antonio F HernándezInstituto de Investigación Biosanitaria (ibs. GRANADA), 18012, Granada, Spain; Department of Legal Medicine and Toxicology, University of Granada School of Medicine, Avda. de la Investigación, 11, 18016, Granada, Spain; Consortium for Biomedical Research in Epidemiology & Public Health, CIBERESP, Madrid, Spain.
Klara HilscherovaRECETOX, Faculty of Science, Masaryk University, Kotlarska 2, 611 37 Brno, Czech Republic.
Spyros KarakitsiosEnvironmental Engineering Laboratory, Department of Chemical Engineering, Aristotle University of Thessaloniki, Thessaloniki, Greece; HERACLES Research Centre on the Exposome and Health, Center for Interdisciplinary Research and Innovation, Thessaloniki, Greece.
Eliska KuchovskaIUF-Leibniz Research Institute for Environmental Medicine, Auf'm Hennekamp 50, 40225, Duesseldorf, Germany.
Manhai LongCentre for Arctic Health & Molecular Epidemiology, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000 Aarhus, Denmark.
Mirjam LuijtenNational Institute for Public Health and the Environment (RIVM), Centre for Health Protection, Bilthoven, the Netherlands.
Sanah MajidKWR Water Research Institute, Groningenhaven 7, 3433 PE Nieuwegein, the Netherlands.
Philip Marx-StoeltingGerman Federal Institute for Risk Assessment, Dept. Pesticides Safety, Berlin, Germany.
Vicente MustielesCenter for Biomedical Research (CIBM) & School of Medicine, University of Granada, 18016 Granada, Spain; Instituto de Investigación Biosanitaria (ibs. GRANADA), 18012, Granada, Spain; Consortium for Biomedical Research in Epidemiology and Public Health (CIBERESP), 28029 Madrid, Spain.
Chander K NegiRECETOX, Faculty of Science, Masaryk University, Kotlarska 2, 611 37 Brno, Czech Republic.
Dimosthenis SarigiannisEnvironmental Engineering Laboratory, Department of Chemical Engineering, Aristotle University of Thessaloniki, Thessaloniki, Greece; HERACLES Research Centre on the Exposome and Health, Center for Interdisciplinary Research and Innovation, Thessaloniki, Greece.
Stefan ScholzUFZ Helmholtz Center for Environmental Research, Dept Bioanalyt Ecotoxicol, D-04318 Leipzig, Germany.
Iva SovadinovaRECETOX, Faculty of Science, Masaryk University, Kotlarska 2, 611 37 Brno, Czech Republic.
Rob StierumNetherlands Organisation for Applied Scientific Research, Risk Analysis for Products in Development, Utrecht, the Netherlands.
Shihori TanabeDivision of Risk Assessment, Center for Biological Safety and Research, National Institute of Health Sciences, Kawasaki, Japan.
Knut Erik TollefsenNorwegian Institute for Water Research (NIVA), Section of Ecotoxicology and Risk Assessment, Gaustadalléen, Oslo, Norway; Norwegian University of Life Sciences (NMBU), Faculty of Environmental Sciences and Natural Resource Management (MINA), Norway.
Annick D van den BrandInstitute for Public Health and the Environment (RIVM), Centre for Nutrition, Prevention and Health Services, 3720 BA Bilthoven, the Netherlands.
Carolina VogsInstitute of Environmental Medicine, Karolinska Institutet, Nobels väg 13, Solna, Sweden; Department of Biomedical Sciences and Veterinary Public Health, Swedish University of Agricultural Sciences, SE-75007 Uppsala, Sweden.
Maria WielsøeCentre for Arctic Health & Molecular Epidemiology, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000 Aarhus, Denmark.
Clemens WittwehrEuropean Commission, Joint Research Centre, Ispra, Italy.
Ludek BlahaRECETOX, Faculty of Science, Masaryk University, Kotlarska 2, 611 37 Brno, Czech Republic. Electronic address: ludek.blaha@recetox.muni.cz.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

While human regulatory risk assessment (RA) still largely relies on animal studies, new approach methodologies (NAMs) based on in vitro, in silico or non-mammalian alternative models are increasingly used to evaluate chemical hazards. Moreover, human epidemiological studies with biomarkers of effect (BoE) also play an invaluable role in identifying health effects associated with chemical exposures. To move towards the next generation risk assessment (NGRA), it is therefore crucial to establish bridges between NAMs and standard approaches, and to establish processes for increasing mechanistically-based biological plausibility in human studies. The Adverse Outcome Pathway (AOP) framework constitutes an important tool to address these needs but, despite a significant increase in knowledge and awareness, the use of AOPs in chemical RA remains limited. The objective of this paper is to address issues related to using AOPs in a regulatory context from various perspectives as it was discussed in a workshop organized within the European Union partnerships HBM4EU and PARC in spring 2022. The paper presents examples where the AOP framework has been proven useful for the human RA process, particularly in hazard prioritization and characterization, in integrated approaches to testing and assessment (IATA), and in the identification and validation of BoE in epidemiological studies. Nevertheless, several limitations were identified that hinder the optimal usability and acceptance of AOPs by the regulatory community including the lack of quantitative information on response-response relationships and of efficient ways to map chemical data (exposure and toxicity) onto AOPs. The paper summarizes suggestions, ongoing initiatives and third-party tools that may help to overcome these obstacles and thus assure better implementation of AOPs in the NGRA.

Indexed as

Adverse Outcome PathwaysHumansRisk AssessmentAdverse outcome pathwaysBiomarkers of effectHazard assessmentMechanistic toxicologyNew approach methodologiesRegulatory risk assessment

Identifiers

PMID36309218
PMCPMC9850416

What OpenQuestion holds

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Registered trials

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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.