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

Autor: Bajard L; RECETOX, Faculty of Science, Masaryk University, Kotlarska 2, 611 37 Brno, Czech Republic., Adamovsky O; RECETOX, Faculty of Science, Masaryk University, Kotlarska 2, 611 37 Brno, Czech Republic., Audouze K; Université Paris Cité, T3S, Inserm UMR S-1124, F-75006 Paris, France., Baken K; Unit Health, Flemish Institute for Technological Research (VITO NV), Boeretang 200, 2400 Mol, Belgium., Barouki R; Université Paris Cité, T3S, Inserm UMR S-1124, F-75006 Paris, France., Beltman JB; Division of Drug Discovery and Safety, Leiden Academic Centre for Drug Research, Leiden University, Leiden, Netherlands., Beronius A; Institute of Environmental Medicine, Karolinska Institutet, Nobels väg 13, Solna, Sweden., Bonefeld-Jørgensen EC; Centre 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., Cano-Sancho G; LABERCA, Oniris, INRAE, Nantes, France., de Baat ML; KWR Water Research Institute, Groningenhaven 7, 3433 PE Nieuwegein, the Netherlands., Di Tillio F; Division of Drug Discovery and Safety, Leiden Academic Centre for Drug Research, Leiden University, Leiden, Netherlands., Fernández MF; Center 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., FitzGerald RE; Swiss Centre for Applied Human Toxicology SCAHT, University of Basel, Missionsstrasse 64, CH-4055 Basel, Switzerland., Gundacker C; Institute of Medical Genetics, Center for Pathobiochemistry and Genetics, Medical University of Vienna, 1090 Vienna, Austria., Hernández AF; Instituto 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., Hilscherova K; RECETOX, Faculty of Science, Masaryk University, Kotlarska 2, 611 37 Brno, Czech Republic., Karakitsios S; Environmental 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., Kuchovska E; IUF-Leibniz Research Institute for Environmental Medicine, Auf'm Hennekamp 50, 40225, Duesseldorf, Germany., Long M; Centre for Arctic Health & Molecular Epidemiology, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000 Aarhus, Denmark., Luijten M; National Institute for Public Health and the Environment (RIVM), Centre for Health Protection, Bilthoven, the Netherlands., Majid S; KWR Water Research Institute, Groningenhaven 7, 3433 PE Nieuwegein, the Netherlands., Marx-Stoelting P; German Federal Institute for Risk Assessment, Dept. Pesticides Safety, Berlin, Germany., Mustieles V; Center 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., Negi CK; RECETOX, Faculty of Science, Masaryk University, Kotlarska 2, 611 37 Brno, Czech Republic., Sarigiannis D; Environmental 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., Scholz S; UFZ Helmholtz Center for Environmental Research, Dept Bioanalyt Ecotoxicol, D-04318 Leipzig, Germany., Sovadinova I; RECETOX, Faculty of Science, Masaryk University, Kotlarska 2, 611 37 Brno, Czech Republic., Stierum R; Netherlands Organisation for Applied Scientific Research, Risk Analysis for Products in Development, Utrecht, the Netherlands., Tanabe S; Division of Risk Assessment, Center for Biological Safety and Research, National Institute of Health Sciences, Kawasaki, Japan., Tollefsen KE; Norwegian 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., van den Brand AD; Institute for Public Health and the Environment (RIVM), Centre for Nutrition, Prevention and Health Services, 3720 BA Bilthoven, the Netherlands., Vogs C; Institute 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., Wielsøe M; Centre for Arctic Health & Molecular Epidemiology, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000 Aarhus, Denmark., Wittwehr C; European Commission, Joint Research Centre, Ispra, Italy., Blaha L; RECETOX, Faculty of Science, Masaryk University, Kotlarska 2, 611 37 Brno, Czech Republic. Electronic address: ludek.blaha@recetox.muni.cz.
Jazyk: angličtina
Zdroj: Environmental research [Environ Res] 2023 Jan 15; Vol. 217, pp. 114650. Date of Electronic Publication: 2022 Oct 27.
DOI: 10.1016/j.envres.2022.114650
Abstrakt: 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.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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