Scientific Opinion on the safety and efficacy of Coxiril® (diclazuril) for rabbits for fattening and breeding
Coxiril® containing 0.5 % diclazuril is intended for the control of coccidiosis in rabbits for fattening at concentrations between 1.0 and 1.2 mg diclazuril/kg complete feed. The highest proposed concentration, 1.2 mg diclazuril from Coxiril®/kg complete feed, is safe for does (pregnant and lactating) and rabbits for fattening with a margin of safety of about 2.5. This conclusion is extended to all rabbits. Diclazuril has no substantial antibacterial activity. Diclazuril from Coxiril® is considered toxicologically equivalent to the currently authorised diclazuril. The use of Coxiril® at the maximum proposed use level, 1.2 mg diclazuril/kg complete feed for rabbits, is safe for the consumer, provided a withdrawal time of two days is respected. Coxiril® is considered non-irritant to eyes and skin. It is not a potential skin sensitiser. User exposure to Coxiril® as a result of normal handling is unlikely to cause respiratory or systemic toxicity. Applying the current standards, no risk for the soil ecosystem could be identified. From three tests required for the risk characterisation of the aquatic ecosystem, only the chronic test with algae provided reliable results, and the two others (acute tests with daphnia and zebra fish) failed to derive a reliable Predicted No-Effect Concentration because of the low water solubility of diclazuril. Consequently, a final risk characterisation for the aquatic environment was not possible. Diclazuril from Coxiril® at a concentration of 1 mg/kg complete feed has the potential to effectively control coccidiosis in rabbits.