TY - JOUR
T1 - 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
T2 - EFSA-Q-2021-00258
AU - Bredsdorff, Lea
AU - Nørby, Karin
AU - Petersen, Annika Boye
AU - Beltoft, Vibe
AU - Boberg, Julie
PY - 2024
Y1 - 2024
N2 - 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.
AB - 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.
KW - Pesticides
KW - Cumulative risk assessment
KW - Cumulative assessment groups
KW - Toxicity endpoints catalogue
KW - Data model
U2 - 10.2903/sp.efsa.2024.EN-9137
DO - 10.2903/sp.efsa.2024.EN-9137
M3 - Journal article
SN - 2397-8325
VL - 21
JO - EFSA Supporting Publications
JF - EFSA Supporting Publications
IS - 12
M1 - 9137E
ER -