Scientific Opinion on the safety and efficacy of Coxiril® (diclazuril) as a feed additive for turkeys for fattening

Abstract

Coxiril®, containing 0.5 % diclazuril, is intended for the control of coccidiosis in turkeys for fattening at concentrations between 0.8 and 1.2 mg diclazuril/kg complete feed. The highest proposed use level (1.2 mg diclazuril/kg feed) is considered safe for turkeys for fattening. Diclazuril has no substantial antibacterial activity. Diclazuril from Coxiril® is considered toxicologically equivalent to the other currently authorised diclazuril. The use of Coxiril® at the highest proposed use level of 1.2 mg diclazuril/kg complete feed in turkeys for fattening is safe for the consumer since Maximum Residue Limits are not exceeded. 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. Based on a Phase I assessment, the use of diclazuril in turkeys for fattening at the high use level does not pose a risk to the environment. Diclazuril from Coxiril® has the potential to control coccidiosis in turkeys for fattening at a minimum concentration of 0.8 mg/kg complete feed. This conclusion is derived from literature data, and from recent studies performed with Coxiril®.

Scientific Opinion on the safety and efficacy of Coxiril® (diclazuril) as a feed additive for guinea fowl

“…22 OJ L 266, 7.10.2008, p. 3. 23 OJ L 38, 9.03.2013 The FEEDAP Panel concluded in its opinion on Coxiril ® for turkeys for fattening (EFSA FEEDAP Panel, 2014b) that the highest proposed use level (1.2 mg diclazuril/kg feed) is safe for this major species. None of the endpoints measured in the tolerance study showed a relevant adverse treatmentrelated effect at the 12-fold use level of diclazuril.…”

“…The efficacy of diclazuril in controlling coccidiosis of chickens for fattening (EFSA FEEDAP Panel, 2014a) and turkeys for fattening (EFSA FEEDAP Panel, 2014b) has been demonstrated at a minimum dose of 0.8 mg/kg complete feed. Considering that the minor species, guinea fowl, is physiologically similar to the major species, chickens for fattening, and that there is some evidence that the effects of diclazuril in Eimeria spp.…”

“…Finally, an opinion on re-evaluation of safety and efficacy of Clinacox ® 0.5 % for chickens reared for laying was adopted in 2013 (EFSA FEEDAP Panel, 2013). The EFSA adopted in 2014 an opinion on the safety and efficacy of Coxiril ® for chickens for fattening (EFSA FEEDAP Panel, 2014a) and turkeys for fattening (EFSA FEEDAP Panel, 2014b).…”

Scientific Opinion on the safety and efficacy of Coxiril®(diclazuril) for rabbits for fattening and breeding

“…Finally, an opinion on re-evaluation of safety and efficacy of Clinacox ® 0.5 % for chickens reared for laying was adopted in 2013 (EFSA FEEDAP Panel, 2013). EFSA adopted in 2014 three opinions on the safety and efficacy of Coxiril ® (diclazuril) for chickens for fattening (EFSA FEEDAP Panel, 2014a), for turkeys for fattening (EFSA FEEDAP Panel, 2014b) and for guinea fowl (EFSA FEEDAP Panel, 2014c).…”

Acute and sub-acute toxicity assessment of ‘Rybozuril’ on common carp

“…The intensity of peroxide oxidation processes in blood plasma was determined by the level of production of its products: primary conjugated dienes (CD) and malonic dialdehyde (MDA) under extraction conditions in a mixture of heptane isopropanol (1:1) as previously described (Gavrilov and Mishkorudnaya, 1983); at wavelengths of 233 and 247 nm; the values of CD expressed as μmol/dm 3 , and MDA at specific absorption rate in 1.0 cm 3 (ΔD/cm 3 ).…”