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Safety and efficacy of Sacox ® microGranulate (salinomycin sodium) for chickens for fattening and chickens reared for laying.
- Source :
-
EFSA journal. European Food Safety Authority [EFSA J] 2017 Jan 26; Vol. 15 (1), pp. e04670. Date of Electronic Publication: 2017 Jan 26 (Print Publication: 2017). - Publication Year :
- 2017
-
Abstract
- 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 Salmonella , Escherichia coli and Campylobacter 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 <superscript>®</superscript> 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 <superscript>®</superscript> 120 microGranulate and Sacox <superscript>®</superscript> 200 microGranulate is considered bioequivalent with respect to its anticoccidial effect.<br /> (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
Details
- Language :
- English
- ISSN :
- 1831-4732
- Volume :
- 15
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- EFSA journal. European Food Safety Authority
- Publication Type :
- Academic Journal
- Accession number :
- 32625262
- Full Text :
- https://doi.org/10.2903/j.efsa.2017.4670