AVILAMYCIN

Overview

Functional Class
Veterinary Drug
ANTIMICROBIAL_AGENT

Evaluations

Evaluation year: 2008

ADI:
0-0.002 mg/kg bw

Comments:
The Committee concluded that the most relevant animal studies for evaluation of the safety of residues of avilamycin in food are the 2-year toxicity study and the multigeneration reproductive study in rats. The NOAEL for both studies was 150 mg avilamycin activity/kg bw per day, the highest dose administered. An ADI of 0–2 mg avilamycin activity/kg bw/ day was established, using a safety factor of 100 and rounding to one significant figure. The recommended MRLs (as DIA & rounded) are 200 µg/kg for muscle, 200 µg/kg for skin/fat, 200 µg/kg for kidney, and 300 µg/kg for liver for pigs, chickens, turkeys and rabbits. The recommended MRLs would result in a daily intake of 5.3 mg of avilamycin, which represents approximately 4% of the upper bound of the ADI.
MRL Comment:
Recommended MRLs for pigs, chicken, turkey and rabbit (as DIA): - Skin/fat 200 (μg/kg) - Kidney 200 (μg/kg) - Liver 300 (μg/kg) - Muscle 200 (μg/kg)
Intake:
At the recommended MRLs: 5.3 mg/p/d
Meeting:
70
Report: 
TRS 954- JECFA 70
Tox Monograph: 
Avilamycin.pdf
Specification: 
FAO JECFA Monographs 6(2009)

Toxicological study

Pivotal Study:
GLP-compliant 3-generation & 2-year carcinogenicity studies in rats (Palmer et al., 1981; Hunter et al., 1983a): Sprague-Dawley (Crl:COBS CD (SD)) rats (25/sex/dose 3-generation study or 80/sex/dose 2-year study) were fed avilamycin at doses of 0, 30, 300 and 3000 mg avilamycin activity/kg in the diet (0, 1.5, 15 and 150 mg avilamycin activity/kg bw/d), where avilamycin was derived from mycelial cake with 7% activity, and at another dose of 3000 mg avilamycin activity/kg in the diet, where the avilamycin was 100% pure active ingredient. For the 3-generation study, animals of the F0 generation were maintained on their respective diets for at least 90 days prior to mating and throughout mating, gestation and lactation. The rats in the 2-year study were from parent rats fed avilamycin at the same doses of 0, 30, 300 or 3000 mg avilamycin activity/kg in the diet for 1 week and then mated and maintained on their treatments during gestation and lactation. There were no treatment-related differences of toxicological significance in any of the parameters examined.
Animal Specie:
Rat
Effect:
None
NOEL:
150 mg/kg bw/d
Point of departure:
150 mg/kg bw/d (highest dose tested)