Data collection, hazard characterisation and establishment of cumulative assessment groups in view of the cumulative risk assessment of pesticide residues for kidneys

Abstract The aim of the present report is to collect data on the toxic effects of various pesticides and their metabolites on the kidneys and subsequently establish cumulative assessment groups (CAGs) to facilitate cumulative risk assessment (CRA) of pesticide residues affecting kidney health. For this purpose, a list of previously defined specific effects and the respective indicators was used to retrieve and organise the relevant data. The specific effects and the respective CAGs considered were glomerular injury, tubular injury, tubular crystals, papillary necrosis, interstitial nephritis, pelvis erosion/ulceration, pelvis calculi/crystals, renal preneoplastic and neoplastic lesions and pelvis preneoplastic and neoplastic lesions. Toxicological data from 35 prioritised pesticide active substances and 3 metabolites were collected from regulatory documents. For each substance a NOAEL and a LOAEL were derived based on the most sensitive histological indicator of the specific effect. Substances were assigned into 9 CAGs for chronic effects and 4 CAGs for effects of acute nature, based on the indicators observed. The identified uncertainties in the CAG allocation and characterisation of the substances were highlighted. Overall, this project utilises the methodology previously developed and described in the EFSA report dealing with the identification of specific effects on kidneys and it provides a comprehensive hazard characterisation of substances affecting the different renal topographical regions.