Safety and efficacy of Sacox microGranulate (salinomycin sodium) for chickens for fattening and chickens reared for laying.

Salinomycin sodium (SAL-Na) is active against certain Gram-positive bacteria, while Gram-negative species are resistant. SAL-Na at the proposed concentration is unlikely to increase shedding of , and and or induce resistance and cross-resistance to antimicrobials important in human and animal therapy. SAL-Na is safe for chickens for fattening at 70 mg/kg complete feed, for chickens reared for laying at 50 mg/kg complete feed in the first 12 weeks of life. The simultaneous use of SAL-Na and certain antibiotic drugs (e.g. tiamulin) is contraindicated. SAL-Na is absorbed and extensively metabolised. Metabolites have reduced ionophoric activity. SAL is the marker residue (MR). No residues in eggs are expected. SAL-Na is not genotoxic and not a carcinogen. A NOAEL of 0.5 mg/kg body weight (bw) per day is derived from a cardiovascular study in dogs as well as from a 12-month dog study. Consumer exposure complies with an acceptable daily intake of 0.005 mg SAL/kg bw after 1 h withdrawal. A withdrawal time and maximum residue limits are not considered necessary. SAL-Na from Sacox is not an irritant to skin and eyes; it is a potential sensitiser to skin and the respiratory tract. A toxicological risk by inhalation for persons handling the additive cannot be excluded. SAL-Na in feed for chickens will not pose a risk for the aquatic environment. A risk for the terrestrial ecosystem is considered unlikely due to metabolisation and the rapid degradation of SAL in the environment. SAL-Na at a minimum concentration of 50 mg/kg complete feed is an effective coccidiostat for chickens for fattening. This conclusion is extended to chickens reared for laying. SAL-Na in Sacox 120 microGranulate and Sacox 200 microGranulate is considered bioequivalent with respect to its anticoccidial effect.