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Safety of Kokcisan 120G as a feed additive for chickens for fattening

Substances used in Animal Feed was asked to issue a scientific opinion on the safety of Kokcisan 120G for chickens for fattening, based on the new data provided by the applicant in the supplementary dossier. The chronic toxicity and carcinogenicity study in rats demonstrates that salinomycin sodium (SAL-Na) from Kokcisan is not carcinogenic and a LOEL of 1.5 mg SAL-Na kg-1 bw day-1could be derived based on marginal, mostly pharmacological effects in haematology and blood biochemistry. This LOEL is three times higher than the lowest NOEL derived from previously submitted short-term studies (0.5 mg SAL-Na kg-1 bw day-1). By applying an uncertainty factor of 100, this NOEL can be taken to deduce an ADI of 0.005 mg SAL-Na from Kokcisan kg-1 bw day-1 (0.3 mg per 60 kg person and day). The FEEDAP Panel considers that the whole metabolites represent a risk which in a worst case is equal to an equivalent quantity of SAL-Na. Regarding the similarity of the metabolic fate of SAL-Na in chicken and rat, the FEEDAP Panel concludes that the ADI based on laboratory animals is a suitable basis for MRL calculation. Residue data on chicken for fattening receiving 70 mg radiolabelled SAL-Na kg-1 feed were provided. At 0.25-day, which corresponds to a practical zero withdrawal, the consumer exposure (0.182 mg) would represent 61 % of the ADI. Therefore, no MRL would normally be required. If for practical reasons a withdrawal period should be established (as already set by the Regulations EC 496/2007 and EC 500/2007 for the SAL-Na containing coccidiostats Salinomax and Sacox, with one day), then MRLs applicable at one-day will be 0.005 mg kg-1 for liver, kidney and muscle and 0.015 mg kg-1 for skin/fat. Consumption of edible tissues containing residues at the MRLs would amount to 58 % of the ADI. Applying a uniform MRL for all tissues of 0.005 mg kg-1 as already set by the above mentioned Regulations, would require a three day withdrawal period for Kokcisan.

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