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{"title":"Update of a database of toxicological effects of pesticides in view of performing cumulative risk assessments. Part 1: Catalogue of toxicity endpoints and data model for the collection of toxicity endpoints.","authors":"Lea Bredsdorff, Karin Nørby, Annika Boye Petersen, Vibe Beltoft, Julie Boberg","doi":"10.2903/sp.efsa.2024.EN-9137","DOIUrl":null,"url":null,"abstract":"<p>A catalogue of toxicity endpoints was developed for a consistent collection of toxicological information. The toxicity endpoints of relevance for cumulative risk assessment were organised in a table for each target organ/tissue/system (cumulative assessment group (CAG) at level 1) including information on specific toxicological effect(s) (CAG at level 2), indicators that reflect the relevance for the CAG at level 2, and descriptions/interpretations that allow an understanding of the CAG at level 2. A data model for the collection of toxicity endpoints was developed to ensure the possibility of integration of the collected data to the EFSA OpenFoodTox database, in order to extend it to non-critical endpoints. The collection of toxicity endpoints and grouping of active substances were performed for a total of 328 active substances and 165 of their metabolites. The data model was filled in for all the OpenFoodTox columns as far as possible and essential information which could not be entered in the OpenFoodTox columns were noted in the ‘Remark column’. In total, 29 CAGs at level 1 have been evaluated for inclusion of specific toxicological effects (CAGs at level 2), whereas four CAG1 targets (gastrointestinal tract, immune system, lungs and skin) were not evaluated as the effects observed in these CAG1 targets were not considered relevant for CAGs at level 2. A number of toxicological effects considered adverse and of relevance for human risk assessment, but generally not relevant for CAGs at level 2, include mortality, clinical signs of toxicity, changes in bodyweight and body weight gain, changes in food consumption and water consumption, changes in clinical biochemistry and urinalysis parameters and changes in organ weights without histopathological changes. © National Food Institute, Technical University of Denmark, 2024</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 12","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-9137","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"EFSA Supporting Publications","FirstCategoryId":"1085","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2024.EN-9137","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
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Abstract
A catalogue of toxicity endpoints was developed for a consistent collection of toxicological information. The toxicity endpoints of relevance for cumulative risk assessment were organised in a table for each target organ/tissue/system (cumulative assessment group (CAG) at level 1) including information on specific toxicological effect(s) (CAG at level 2), indicators that reflect the relevance for the CAG at level 2, and descriptions/interpretations that allow an understanding of the CAG at level 2. A data model for the collection of toxicity endpoints was developed to ensure the possibility of integration of the collected data to the EFSA OpenFoodTox database, in order to extend it to non-critical endpoints. The collection of toxicity endpoints and grouping of active substances were performed for a total of 328 active substances and 165 of their metabolites. The data model was filled in for all the OpenFoodTox columns as far as possible and essential information which could not be entered in the OpenFoodTox columns were noted in the ‘Remark column’. In total, 29 CAGs at level 1 have been evaluated for inclusion of specific toxicological effects (CAGs at level 2), whereas four CAG1 targets (gastrointestinal tract, immune system, lungs and skin) were not evaluated as the effects observed in these CAG1 targets were not considered relevant for CAGs at level 2. A number of toxicological effects considered adverse and of relevance for human risk assessment, but generally not relevant for CAGs at level 2, include mortality, clinical signs of toxicity, changes in bodyweight and body weight gain, changes in food consumption and water consumption, changes in clinical biochemistry and urinalysis parameters and changes in organ weights without histopathological changes. © National Food Institute, Technical University of Denmark, 2024
根据进行累积风险评估,更新农药毒理学影响数据库。第1部分:毒性终点目录和收集毒性终点的数据模型。
制定了毒性终点目录,以便一致地收集毒理学信息。与累积风险评估相关的毒性终点被组织在每个目标器官/组织/系统(1级累积评估组(CAG))的表格中,包括特定毒理学效应的信息(CAG为2级),反映CAG为2级相关性的指标,以及允许理解CAG为2级的描述/解释。开发了一个收集毒性终点的数据模型,以确保收集到的数据集成到EFSA OpenFoodTox数据库的可能性,以便将其扩展到非关键终点。对328种活性物质及其165种代谢物进行了毒性终点收集和活性物质分组。数据模型被尽可能地填充到所有的OpenFoodTox列中,不能在OpenFoodTox列中输入的重要信息被标注在“Remark列”中。总共有29个1级cag被评估为包含特定毒理学效应(2级cag),而4个CAG1靶点(胃肠道、免疫系统、肺和皮肤)没有被评估,因为在这些CAG1靶点观察到的效应被认为与2级cag无关。许多毒理学效应被认为是不利的,与人类风险评估相关,但通常与2级cag无关,包括死亡率、临床毒性体征、体重变化和体重增加、食物消耗和水消耗的变化、临床生物化学和尿液分析参数的变化以及无组织病理学变化的器官重量变化。©丹麦技术大学国家食品研究所,2024
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