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Processing studies

Apples. Apples were processed to juice, wet pomace and purée according to household procedures. In trials in Germany, apples treated at 2 or 3 times the recommended rate were harvested at 25-28 days and processed to purée. The residue levels of tebufenozide in the purée, washings, and peels and pips were 43%, 1%, and 59% of those in the apples.

In another study, when apples were processed to obtain juice and pomace, the residue levels in the juice were 15% and in the wet pomace 108% of those in the apples.

In a trial in the USA, apples were processed to wet pomace, unpasteurized juice and pasteurized juice in simulated commercial processing. Pasteurized and unpasteurized juice contained almost identical residues of 5% of the residue level in the unwashed fruit. Residues in wet apple pomace were concentrated about fourfold. Washing the treated fruit reduced the residues by about 20%.

The results indicated an apparent concentration of the residues from whole apples to wet pomace of 1-4 times, with an average of 2.5 times, and a reduction of residues in purée and juice by factors of 4 and 8 respectively. Pasteurization did not change the residue level in the juice.

The Meeting estimated STMR-Ps of 0.4 mg/kg for wet apple pomace and 0.02 mg/kg for apple juice.

Grapes. Trials were carried out in France, Germany and Italy to study the fate of tebufenozide in processed products. Residues in wine decreased 2-13-fold, with an average factor of 4, while pomace showed a concentration of the residue by factors of 1.6-3.7, with an average of 2.7, although only three results were available.

The Meeting estimated STMR-Ps of 0.36 mg/kg for wet grape pomace and 0.03 mg/kg for wine. Tea. Twelve to 30% of the tebufenozide found in dry tea was transfered to the tea infusion.

Animal feeding studies. In a study in Japan two cows were dosed by capsule with 40 or 400 mg/day of tebufenozide for 7 days. The dose levels corresponded to 0.07 and 0.74 mg/kg bw/day. Milk samples showed no detectable residues of tebufenozide. The LOD was 0.02 mg/kg.

Because of the short duration of the study and because the dose levels were not confirmed by analysis only milk was analysed, the Meeting could not estimate a maximum residue level.

No poultry feeding studies were reported to the Meeting, but the results of the metabolism study in hens demonstrated that transfer of the residues from the diet to the tissues or eggs is low. As the study was for only 7 days and plateau level could not be reached, the Meeting concluded that it was not an inadequate basis for the estimation of maximum residue levels.

Of the studied crops, the main animal feed component contributing to the diet of beef or dairy cattle is apple pomace. On the basis of the maximum residue level estimated for pome fruit (1 mg/kg), and the mean concentration factor from fruit to pomace of 2.5, the maximum theoretical dietary intake of tebufenozide can be estimated as 2.5 mg/kg for beef cattle and 1.3 mg/kg for dairy cows.

No data were provided on the residues in the edible portions of food commodities apart from those included in the supervised trials or processing studies.

No information was provided on the residues of tebufenozide occurring in commerce or at consumption.


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