Abstract
Safety evaluation of Acequinocyl was conducted via comprehensive studies. Acute toxicity is very low in every exposure route for both Acequinocyl and the 15% SC formulation. Primary irritation potential of Acequinocyl 15% SC formulation is minimal for eyes and nil for skin. Acequinocyl 15% SC formulation has no skin sensitization potential. In long term studies, hemorrhagic changes and/or prolonged blood clotting time were observed in rats treated with high doses of Acequinocyl. Similar changes were also observed in pharmacology studies in which rats dosed with a single high dose of Acequinocyl showed increased fibrinogen level and prolonged blood clotting time. As Acequinocyl has a chemical structure similar to that of vitamin K, it is assumed that Acequinocyl competes against vitamin K in the mechanism of blood coagulation in rats. No effect on reproductive ability was observed in rats. In teratogenicity studies, no teratogenic effect was observed even in the highest doses that induced embryotoxic changes. No mutagenic effect was observed in genetic toxicity studies, and no specific non-neoplastic/neoplastic lesions were observed in chronic studies. ADI value for Acequinocyl was established at 0.027mg/kg/day based on the NOAEL in the 80-Week Carcinogenicity Study In Mice. Maximum residue levels on crops established by the Japanese Ministry of Health and Welfare are 1ppm for eggplants, 0.5ppm for cucumbers and gherkins, 0.1ppm for watermelons and melons, 0.2ppm for mandarin oranges, 2ppm for natsudaidai, 1ppm for lemons and other citrus fruits than mandarin oranges and natsudaidai, 1ppm for apples, 2ppm for pears and Japanese pears, 0.1ppm for peaches, 1ppm for plums and prunes, 2ppm for cherries and 0.5ppm for grapes. Acequinocyl 15% SC formulation is considered to be a useful agent in the agricultural field on account of its excellent acaricidal effect and minimal risk to humans and the environment when used in accordance with the instructions.
