DECTOMAX©

Comments:

An ADI for doramectin of 0–1 µg/kg of bw was established on the basis of a NOEL of 0.1 mg/kg bw per day for mydriasis in a 3-month study in dogs treated by gavage, with a safety factor of 100. The Committee noted that removal of the twofold safety factor resulted in an ADI that still provided an adequate margin of safety for all other toxicological end-points. The Committee also noted that the resulting ADI for dormectin is 150–200 times lower than the human therapeutic dose of the related compound ivermectin. The Committee took special note of the available information on reduced expression of P-glycoprotein in humans, which results in increased bioavailability of substrates for this transporter. However, the effects on the bioavailability of avermectins and their ability to penetrate the blood–brain barrier are unknown. The Committee recommended that human populations continue to be monitored for possible genetic predisposition to sensitivity to avermectins.

MRL Comment:

MRLs (expressed as doramectin) recommended in previous meetings were maintained: Muscle (cattle): 0.01 mg/kg; muscle (pigs): 0.005 mg/kg; liver (cattle and pigs): 0.1 mg/kg; kidney (cattle and pigs): 0.03 mg/kg; fat (cattle and pigs): 0.15 mg/kg. At the present meeting an MRL of 0.15 mg/kg was recommended for milk (cattle). The Committee noted that the discard time necessary to accommodate the recommended MRL in milk is unlikely to be consistent with good veterinary practice.

MRL Code:

MRL

Intake:

TMDI: 3.66 mg/p/d total

Meeting:

62

Report: 

Tox Monograph: 

Residues: 

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