Scientific Opinion on safety and efficacy of Clinacox® 0.5% (diclazuril) for chickens for fattening
Published:
Adopted:
Updated:
Wiley Online Library
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Keywords
coccidiostat, diclazuril, chickens for fattening, safety, ADI, MRLs, efficacy
On request from
European Commission
Question Number
EFSA-Q-2008-749
Panel members at the time of adoption
Gabriele Aquilina, Georges Bories, Paul Brantom, Andrew Chesson, Pier Sandro Cocconcelli, Joop de Knecht, Noël Albert Dierick, Mikolaj Antoni Gralak, Jürgen Gropp, Ingrid Halle, Reinhard Kroker, Lubomir Leng, Sven Lindgren, Anne-Katrine Lundebye Haldorsen, Alberto Mantovani, Miklós Mézes, Derek Renshaw and Maria Saarela.
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Abstract
Clinacox® 0.5% (containing 0.5 % diclazuril) is intended to be used as a coccidiostat for chickens for fattening. Feeding 1 mg diclazuril/kg feed was safe for chickens for fattening (margin of safety of at least 25) and effective in controlling coccidiosis. Ingested diclazuril is absorbed and biotransformed to a limited extent, the parent compound being the main metabolite and marker substance. Diclazuril is not genotoxic or carcinogenic, and no major concern appeared in reproductive/developmental studies. The NOEL in a chronic mouse study was 2.9 mg/kg bw/day, yielding an ADI of 0.029 mg/kg bw. The maximum theoretical consumer exposure would be 13 % of the ADI when no withdrawal period is applied. MRLs are set at 1.5, 1.0, 0.5 and 0.5 mg/kg liver, kidney, muscle and skin/fat, respectively. No safety concern would arise for workers handling Clinacox® 0.5%. The use of Clinacox® 0.5% in chickens for fattening at the recommended dose does not pose a risk for the environment.
© European Food Safety Authority, 2010