Edition en ligne: "Résidus pour les médicaments vétérinaires"

Aide en ligne Terminology

Cette base de données contient l'information la plus récente sur les niveaux de résidus maximum pour les médicaments vétérinaires recommandés par JECFA. Toute la documentation publiée dans l'étude FAO Alimentation et Nutrition No. 41 est disponible en ligne en format numérique. Cette documentation existe seulement en Anglais, tandis que les pages d'information générale et une partie de la base de données sont traduites en Anglais, Français, Espagnol, Arabe et Chinois.

Médicament vétérinaire

Ivermectin

Classe fonctionnelle

Antiparasitic agent

Dernière évaluation

2015

Réunion de JECFA

DJA

0-10 µg/kg bw

Statut de la DJA

Full

Monographies des résidus

15-2013-ivermectin.pdf

18-2015-Ivermectin.pdf

Définition du résidu

Ivermectin B1a

Limites maximales de résidu
(LMR) recommandés

Cattle	Fat	400 µg/kg	F
Cattle	Kidney	100 µg/kg	F
Cattle	Liver	800 µg/kg	F
Cattle	Milk	10 µg/kg	F
Cattle	Muscle	30 µg/kg	F
Pig	Fat	20 µg/kg	F
Pig	Liver	15 µg/kg	F
Sheep	Fat	20 µg/kg	F
Sheep	Liver	15 µg/kg	F

Autres remarques

The Committee established an ADI of 0–10 µg/kg body weight on the basis of a no-observed-adverse-effect level (NOAEL) of 0.5 mg/kg body weight per day for neurological effects (mydriasis) and retardation of weight gain in a 14-week dog study, with application of an uncertainty factor of 50 (5 for interspecies differences based on pharmacokinetic studies in dogs and humans and 10 for intraspecies differences). The previous ADI of 0–1 µg/kg body weight was withdrawn.

Résumé de l'évaluation

The ADI established by the Committee was 0–10 μg/kg bw. An ARfD of 200 μg/kg bw was established by the Committee. Ivermectin B1a (synonym for 22,23-dihydroavermectin B1a) is confirmed as the marker residue. The ratios of the marker residue to total residues of 0.18 in fat, 0.54 in kidney, 0.37 in liver and 0.67 in muscle defined by the fortieth JECFA were confirmed. Two studies were used for deriving the MRLs and represent different formulations and routes of administration of ivermectin to cattle. The analysis of all data in cattle shows comparable residue depletion profiles. A validated quantitative analytical method for all edible tissues is available and is suitable for regulatory monitoring. The MRLs recommended for cattle tissues are based on the upper limit of the one-sided 95% confidence interval over the 95th percentile of residue concentrations (95/95 UTL) for the day 14 post-treatment data from the non-radiolabelled residue depletion studies. The time point chosen is consistent with approved uses (GVP). Based on the new assessment, the Committee recommended the following revised MRLs in cattle tissues: 400 μg/kg for fat, 100 μg/kg for kidney, 800 μg/kg for liver, and 30 μg/kg for muscle.