Development of Integrated Approaches to Testing and Assessment (IATA) case studies on developmental neurotoxicity (DNT) risk assessment

被引:39
作者
Hernandez-Jerez, Antonio
Adriaanse, Paulien
Aldrich, Annette
Berny, Philippe
Coja, Tamara
Duquesne, Sabine
Focks, Andreas
Marinovich, Marina
Millet, Maurice
Pelkonen, Olavi
Pieper, Silvia
Tiktak, Aaldrik
Topping, Christopher
Widenfalk, Anneli
Wilks, Martin
Wolterink, Gerrit
Crofton, Kevin
Hougaard Bennekou, Susanne
Paparella, Martin
Tzoulaki, Ioanna
机构
关键词
IATA; developmental neurotoxicity; DNT; AOP; Deltamethrin; Flufenacet; in vitro; evidence-; based; uncertainty analysis; PYRETHROID INSECTICIDE EXPOSURE; NEURODEVELOPMENTAL DISORDERS; PESTICIDE EXPOSURE; EPIDEMIOLOGY; CHILDREN;
D O I
10.2903/j.efsa.2021.6599
中图分类号
TS2 [食品工业];
学科分类号
0832 ;
摘要
The EFSA Panel on Plant Protection Products and their Residues (PPR) has developed, as a self-task mandate (EFSA-Q-2019-00100), two adverse outcome pathway (AOP)-informed integrated approach to testing and assessment (IATA) case studies to answer a developmental neurotoxicity (DNT) hazard identification and characterisation problem formulation that could support the regulatory decisions for the pesticide active substances deltamethrin and flufenacet. The IATA were developed to assess the applicability of the DNT in vitro testing battery (IVB), designed to explore fundamental neurodevelopmental processes, in the regulatory risk assessment of pesticides. For this purpose, an evidence-based-approach methodology was applied: 1) systematic literature review and critical appraisal of all the evidence i.e. human observational studies, in vivo data from rodent models and new approach methodologies (NAMs, i.e. in vitro studies including high-throughput testing from IVB and zebrafish studies from the literature) for both case studies; 2) a quantitative uncertainty analysis of all the evidence using expert knowledge elicitation (EKE) and a probabilistic approach; 3) integration of all the evidence using the AOP conceptual framework. This stepwise approach resulted in the postulation of an evidence-based AOP network for one of the case studies. A probabilistic quantification of the weight of evidence (WoE) using Bayesian network analysis allowed the assessment and the quantification of the uncertainty in the postulated AOP. The approach taken allowed conclusions to be drawn with an acceptable level of certainty in DNT hazard identification and characterisation of deltamethrin and that flufenacet is not a developmental neurotoxicant, supporting the relevance of the mechanistic understanding. The case studies show the applicability of the DNT-IVB for hazard identification and characterisation and illustrate the usefulness of an AOP-informed IATA for regulatory decision making. The overall activity led to improved interpretation of human data by providing a plausible mechanistic link to adverse outcomes, which would support their contextualisation in the risk assessment process. This Scientific Opinion allows the PPR Panel to draft several recommendations for the implementation of the AOP-informed IATA methodology and of the DNT-IVB in the regulatory risk assessment of pesticides. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
引用
收藏
页数:63
相关论文
共 50 条
[41]   Development and psychometric testing of a Gastric Cancer Behavioural Risk Assessment Inventory (GC-BRAI) [J].
Razavi, Sadigheh ;
Mahmoodi, Hassan ;
Pandari, Hassan ;
Sarbakhsh, Parvin ;
Shaghaghi, Abdolreza .
EASTERN MEDITERRANEAN HEALTH JOURNAL, 2021, 27 (01) :50-58
[42]   Risk Assessment Integrated QbD Approach for Development of Optimized Bicontinuous Mucoadhesive Limicubes for Oral Delivery of Rosuvastatin [J].
Javed, Md Noushad ;
Kohli, Kanchan ;
Amin, Saima .
AAPS PHARMSCITECH, 2018, 19 (03) :1377-1391
[43]   Toxicity Testing in the 21st Century: Defining New Risk Assessment Approaches Based on Perturbation of Intracellular Toxicity Pathways [J].
Bhattacharya, Sudin ;
Zhang, Qiang ;
Carmichael, Paul L. ;
Boekelheide, Kim ;
Andersen, Melvin E. .
PLOS ONE, 2011, 6 (06)
[44]   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 [J].
Miriam N. Jacobs ;
Annamaria Colacci ;
Raffaella Corvi ;
Monica Vaccari ;
M. Cecilia Aguila ;
Marco Corvaro ;
Nathalie Delrue ;
Daniel Desaulniers ;
Norman Ertych ;
Abigail Jacobs ;
Mirjam Luijten ;
Federica Madia ;
Akiyoshi Nishikawa ;
Kumiko Ogawa ;
Kiyomi Ohmori ;
Martin Paparella ;
Anoop Kumar Sharma ;
Paule Vasseur .
Archives of Toxicology, 2020, 94 :2899-2923
[45]   Application of the BRAFO tiered approach for benefit-risk assessment to case studies on heat processing contaminants [J].
Schutte, Katrin ;
Boeing, Heiner ;
Hart, Andy ;
Heeschen, Walther ;
Reimerdes, Ernst H. ;
Santare, Dace ;
Skog, Kerstin ;
Chiodini, Alessandro .
FOOD AND CHEMICAL TOXICOLOGY, 2012, 50 :S724-S735
[46]   Integrated regional ecological risk assessment of multi-ecosystems under multi-disasters: a case study of China [J].
Xu, Xuegong ;
Xu, Lifen ;
Yan, Lei ;
Ma, Luyi ;
Lu, Yaling .
ENVIRONMENTAL EARTH SCIENCES, 2015, 74 (01) :747-758
[47]   Preliminary Development and Testing of the Risk Assessment Checklist for Self-Injury in Autism-Medical (RACSA-M) [J].
Alberts, Lisa B. ;
Kettering, Tracy L. .
JOURNAL OF DOCTORAL NURSING PRACTICE, 2022, 15 (02) :75-83
[48]   Integrated regional ecological risk assessment of multi-ecosystems under multi-disasters: a case study of China [J].
Xuegong Xu ;
Lifen Xu ;
Lei Yan ;
Luyi Ma ;
Yaling Lu .
Environmental Earth Sciences, 2015, 74 :747-758
[49]   LMO1 polymorphisms and the risk of neuroblastoma: Assessment of meta-analysis of case-control studies [J].
Hashemi, Mohammad ;
Sarabandi, Sahel ;
Karami, Shima ;
Smieja, Jaroslaw ;
Moazeni-Roodi, Abdolkarim ;
Ghavami, Saeid ;
Los, Marek J. .
JOURNAL OF CELLULAR AND MOLECULAR MEDICINE, 2020, 24 (02) :1160-1168
[50]   Integration of toxicodynamic and toxicokinetic new approach methods into a weight-of-evidence analysis for pesticide developmental neurotoxicity assessment: A case-study with DL- and L-glufosinate [J].
Dobreniecki, Sarah ;
Mendez, Elizabeth ;
Lowit, Anna ;
Freudenrich, Theresa M. ;
Wallace, Kathleen ;
Carpenter, Amy ;
Wetmore, Barbara A. ;
Kreutz, Anna ;
Korol-Bexell, Evgenia ;
Friedman, Katie Paul ;
Shafer, Timothy J. .
REGULATORY TOXICOLOGY AND PHARMACOLOGY, 2022, 131