Zilpaterol hydrochloride. Residue Monograph of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), 81st meeting 2015
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FAO/WHO ;
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The 78th meeting of the Committee, at the request of the 21st Session of CCRVDF (FAO/WHO, 2014a), evaluated zilpaterol HCl and established an ADI of 0–0.04 μg/kg bw on the basis of a LOAEL for a slight increase of tremor in humans in a single dose study (FAO/WHO, 2014b). The 78th meeting of the Committee also agreed that parent zilpaterol was an appropriate marker residue in muscle. Only limited data were available for tissues other than muscle, and the Committee was unable to determine a suitab le marker residue in other edible tissues. Liver and kidney contained the highest concentration of zilpaterol at all sampling times, followed by muscle. The ratios of the concentration of zilpaterol to the concentration of the total residues for liver and for kidney over the 96-hour withdrawal period after the last drug administration could not be determined with any confidence due to the very limited data available and lack of sensitivity of the methods used. The data provided were not sufficie nt to determine the total residue half-life in the liver after 96 hours. There are no measurable residues in adipose fat.