IVERMECTIN

Comments:

The Committee established an ADI at the eighty-first meeting. The Committee established an ARfD of 200 µg/kg body weight at the eighty-first meeting.

MRL Comment:

Pigs: 15μg/kg for muscle, 30µg/kg for liver, 20μg/kg for kidney and 50μg/kg for fat. Sheep and goats: 30μg/kg for muscle, 60μg/kg for liver, 20μg/kg for kidney and 100μg/kg for fat.

Intake:

The GECDE was 0.72, 0.93 and 0.48μg/kgbw per day (7.2%, 9.3% and 4.8% of the upper bound of the ADI of 10μg/kg bw) for adults and the elderly, children and adolescents, and toddlers and infants, respectively. The GEADE was 69, 73 and 30μg/kgbw (35%, 37% and 15% of the ARfD) from consumption of cattle, sheep and pig muscle respectively, for both the general population and children.

Meeting:

94

Report: 

ADI:

0–10 μg/kg bw (2015)

Comments:

The ADI established by the Committee at the 81st meeting remains unchanged. The ARfD of 0.2 mg/kg bw established by the Committee at the 81st meeting remains unchanged.

MRL Comment:

The Committee established MRLs for sheep, pigs and goats of 20 µg/kg for fat, 15 µg/kg for kidney, 15 µg/kg for liver and 10 µg/kg for muscle.

Intake:

The Committee established a GECDE for the general population of 0.41 μg/kg bw per day, which represents 4% of the upper bound of the ADI. The Committee established a GECDE for children of 0.59 μg/kg bw per day, which represents 5.9% of the upper bound of the ADI. The Committee established a GEADE for the general population of 87 µg/kg bw per day, which represents 43% of the ARfD, from consumption of cattle muscle, and of 1.1 µg/kg bw, which represents 0.6% of the ARfD, from consumption of sheep muscle. The Committee established a GEADE for children of 82 µg/kg bw per day, which represents 41% of the ARfD, from consumption of cattle muscle and of 1.0 µg/kg bw, which represents 0.5% of the ARfD, from consumption of sheep muscle.

Meeting:

88

Report: 

ADI:

0–10 μg/kg bw

Comments:

ARfD of 200 μg/kg bw

MRL Comment:

400 μg/kg for fat, 100 μg/kg for kidney, 800 μg/kg for liver and 30 μg/kg for muscle in cattle

Intake:

6 to 15% of the ADI respectively for EDI and GECDE

Report: 

Tox Monograph: 

Residues: 

ADI:

0–1 μg/kg bw

Comments:

The Committee established an ADI of 0–1 μg/kg body weight at its fortieth meeting (WHO TRS No. 832, 1993).

MRL Comment:

Recommended maximum residue limits (MRLs) In Cattle 4 μg/kg(Muscle) as Ivermectin B1a

Intake:

The fortieth meeting of the Committee (WHO TRS No. 832, 1993) included an estimate of the potential intake from muscle. No furtherassessment of dietary exposure was undertaken at the current meeting.

Meeting:

78

Report: 

Residues: 

ADI:

0–1 μg/kg bw

Comments:

The 19th Session of CCRVDF requested the re-evaluation of the ADI of ivermectin and, if necessary, the recommendation of new MRLs. The 40th Committee meeting previously established an ADI of 0–1 μg/kg bw, based on a NOEL of 0.1 mg/kg bw/d for maternal toxicity in from a developmental toxicity study in CF-1 mice and a safety factor of 100. The current Committee meeting concluded that there was a need to identify a critical effect other than in the CF-1 mouse for the establishment of an ADI, based on reports on the effects of ivermectin when used as a therapeutic agent in humans and information from in vitro and/or in vivo studies evaluating the critical effects upon which recent ADIs for other avermectins have been established.

MRL Comment:

Before proposing updated MRLs, the Committee requested submission of the following information: complete up-to-date list of approved products on the market together with documentation of approved uses, including withdrawal times and all relevant parts of proprietary studies directly or indirectly supporting the approved uses, and an expert report summarizing the above content of the submission and additional relevant published data. Validated contemporary analytical methods should also be provided.

Meeting:

75

Report: 

Residues: 

ADI:

0-0.001 mg/kg bw (1992)

MRL Comment:

MRL (expressed as ivermectin B1a): Milk (cattle) 0.01 mg/kg. The MRLs recommended at the fortieth meeting (1992) were not reconsidered and were maintained.

MRL Code:

MRL

Meeting:

40

Report: 

Tox Monograph: 

Residues: 

Previous Years: