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Lola Bajard, Ondřej Adamovský, Karine Audouze, Kirsten A. Baken, Robert Barouki, Joost B. Beltman, Anna Beronius, Eva Cecilie Bonefeld‐Jørgensen, Germán Cano-Sancho, Milo L. de Baat and 25 more
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.
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Bajard, L., Adamovský, O., Audouze, K., Baken, K. A., Barouki, R., Beltman, J. B., Beronius, A., Bonefeld‐Jørgensen, E. C., Cano-Sancho, G., Baat, M. L. D., Tillio, F. D., Fernández, M. F., FitzGerald, R., Gundacker, C., Hernández, A. F., Hilscherová, K., Karakitsios, S., Kuchovská, E., Long, M., … Bláha, L. (2022). Application of AOPs to assist regulatory assessment of chemical risks – Case studies, needs and recommendations. Environmental Research, 217, 114650. https://doi.org/10.1016/j.envres.2022.114650
Bajard, Lola, et al. "Application of AOPs to assist regulatory assessment of chemical risks – Case studies, needs and recommendations." Environmental Research, vol. 217, 2022, pp. 114650, https://doi.org/10.1016/j.envres.2022.114650.
Bajard, Lola, Ondřej Adamovský, Karine Audouze, Kirsten A. Baken, Robert Barouki, Joost B. Beltman, Anna Beronius, et al. "Application of AOPs to assist regulatory assessment of chemical risks – Case studies, needs and recommendations." Environmental Research 217 (2022): 114650. https://doi.org/10.1016/j.envres.2022.114650.
Bajard L., Adamovský O., Audouze K. [и др.] Application of AOPs to assist regulatory assessment of chemical risks – Case studies, needs and recommendations // Environmental Research. — 2022. — Vol. 217. — P. 114650. — URL: https://doi.org/10.1016/j.envres.2022.114650
@article{bajard2022application,
title = {{Application of AOPs to assist regulatory assessment of chemical risks – Case studies, needs and recommendations}},
author = {Lola Bajard and Ondřej Adamovský and Karine Audouze and Kirsten A. Baken and Robert Barouki and Joost B. Beltman and Anna Beronius and Eva Cecilie Bonefeld‐Jørgensen and Germán Cano-Sancho and Milo L. de Baat and Filippo Di Tillio and Mariana Fátima Fernández and Rex FitzGerald and Claudia Gundacker and Antonio F. Hernández and Klára Hilscherová and Spyros Karakitsios and Eliška Kuchovská and Manhai Long and Mirjam Luijten and Sanah Majid and Philip Marx‐Stoelting and Vicente Mustieles and Chander K. Negi and Dimosthenis Andreas Sarigiannis and Stefan Scholz and Iva Sovadinová and Rob H. Stierum and Shihori Tanabe and Knut Erik Tollefsen and Annick D. van den Brand and Carolina Vogs and Maria Wielsøe and Clemens Wittwehr and Luděk Bláha},
journal = {Environmental Research},
year = {2022},
volume = {217},
pages = {114650},
doi = {10.1016/j.envres.2022.114650},
url = {https://doi.org/10.1016/j.envres.2022.114650}
}TY - JOUR AU - Bajard, Lola AU - Adamovský, Ondřej AU - Audouze, Karine AU - Baken, Kirsten A. AU - Barouki, Robert AU - Beltman, Joost B. AU - Beronius, Anna AU - Bonefeld‐Jørgensen, Eva Cecilie AU - Cano-Sancho, Germán AU - Baat, Milo L. de AU - Tillio, Filippo Di AU - Fernández, Mariana Fátima AU - FitzGerald, Rex AU - Gundacker, Claudia AU - Hernández, Antonio F. AU - Hilscherová, Klára AU - Karakitsios, Spyros AU - Kuchovská, Eliška AU - Long, Manhai AU - Luijten, Mirjam AU - Majid, Sanah AU - Marx‐Stoelting, Philip AU - Mustieles, Vicente AU - Negi, Chander K. AU - Sarigiannis, Dimosthenis Andreas AU - Scholz, Stefan AU - Sovadinová, Iva AU - Stierum, Rob H. AU - Tanabe, Shihori AU - Tollefsen, Knut Erik AU - Brand, Annick D. van den AU - Vogs, Carolina AU - Wielsøe, Maria AU - Wittwehr, Clemens AU - Bláha, Luděk TI - Application of AOPs to assist regulatory assessment of chemical risks – Case studies, needs and recommendations JO - Environmental Research VL - 217 SP - 114650 PY - 2022 DA - 2022/10/26 DO - 10.1016/j.envres.2022.114650 UR - https://doi.org/10.1016/j.envres.2022.114650 ER -
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