Verification of health-based guidance values for carbendazim.

Abstract

Carbendazim is registered on the Japanese positive list (PL) for food contact materials (food utensils, containers, and packaging; UCP). However, to ensure food safety, a dietary risk assessment of carbendazim is necessary. The safety of carbendazim has been evaluated by several risk assessment bodies, from which health-based guidance values (HBGVs) have been established, mainly based on the no observed adverse effect level (NOAEL) approach. However, as most of the reviewed studies were not conducted in accordance with Good Laboratory Practice (GLP) or OECD test guidelines (TGs), they may not have fully met quality standards. Following the results of periodic re-evaluations, some HBGVs have been withdrawn owing to insufficient toxicological information. Therefore, we verified the HBGVs of carbendazim from the perspective of genotoxicity. The point of departure (PoD) for aneugenicity was calculated based on a dose-response analysis from in vivo micronucleus tests using the benchmark dose (BMD) approach. Overall, the HBGV based on the PoD of aneugenicity was comparable with the existing HBGV based on developmental toxicity tests in rats and rabbits using the NOAEL approach.