Opinion on Genotoxic and Carcinogenic Potential of Buprofezin in the Context of the Human Risk Assessment ‐ Scientific Opinion of the Panel on Plant Protection Products and their Residues (PPR)

SUMMARY Buprofezin is an insecticide with a thiadiazine structure. This active substance was proposed for inclusion in Annex I of the Directive 91/414/EEC in 2005, but in the Draft Assessment Report (DAR), the Rapporteur Member State (Finland) identified a data gap: “new studies for in vitro and in vivo chromosomal aberration assays were required because the potency to cause chromosomal aberrations was insufficiently studied through the submitted information”. In the light of the results of the new genotoxicity studies the carcinogenic potential of buprofezin was reassessed by the Pesticide Risk Assessment Peer Review (PRAPeR) expert meeting (EFSA) but a conclusion could not be reached. Therefore the Scientific Panel on Plant Protection Products and their Residues (PPR Panel) of EFSA was asked for an opinion by the PRAPeR Unit on the genotoxic and carcinogenic potential of buprofezin in the context of the human risk assessment. The PPR Panel re-evaluated the long-term toxicity/carcinogenicity studies on buprofezin. Two studies on the carcinogenicity of buprofezin were conducted in mice and rats. The PPR Panel concluded that the differences from the EU guidelines in the protocol for the carcinogenicity study in rats were not such as to prevent its use for the evaluation of the carcinogenic potential of the test compound. In mice and rats, neither the nature nor the incidence of tumours was affected by the administration of buprofezin. The PPR Panel re-evaluated the genotoxicity studies on buprofezin.