Halquinol

Overview

CAS number

8067-69-4

JECFA number

Functional Class

Veterinary Drug
ANTIMICROBIAL_AGENT
GROWTH_PROMOTER
Veterinary Drug

Evaluations

Evaluation year: 2019

ADI:
0–0.2 mg/kg bw

Comments:

The Committee established an ADI based on histopathological changes in the kidney, accompanied by increases in absolute and relative renal weight in a 1-year chronic toxicity study in rats, applying a safety factor of 100 (10 for interspecies variability and 10 for intraspecies variability). The Committee established an ARfD of 0.3 mg/kg bw, based on a NOAEL of 30 mg/kg bw for clinical signs in dams observed in a developmental toxicity study in mice, with application of a safety factor of 100 (10 for interspecies variability and 10 for intraspecies variability).

MRL Comment:

The Committee recommended MRLs in swine of 40 µg/kg for muscle, 350 µg/kg for skin+fat, 500 µg/kg for liver and 9000 µg/kg for kidney.

Intake:

Estimated chronic dietary exposure: The GECDE for the general population is 5.9 μg/kg bw per day, which represents 3% of the upper bound of the ADI. The GECDE for children is 6.9 μg/kg bw per day, which represents 3.4% of the upper bound of the ADI. Estimated acute dietary exposure: The GEADE was comparable for children and adults, being 2–224 μg/kg bw per day, which represents 0.5–75% of the ARfD.

Meeting:

Report:

TRS1023-JECFA88

Tox Monograph:

FAS79-JECFA88

Residues:

FAO JECFA Monograph

Toxicological study

Pivotal Study:

1-year toxicity and carcinogenicity study (diet)

Animal Specie:

Rats

Effect:

Histopathological changes in the kidney

NOAEL:

15mg/kg bw per day

Evaluation year: 2017

ADI:

An ADI cannot be established due to the lack of information required to assess the in vivo mutagenicity and carcinogenicity potential.

Comments:

A microbiological ADI of 0–0.3 mg/kg bw was established based on the effects of halquinol on the intestinal microbiota. A microbiological ARfD of 0.9 mg/kg bw, was established based on the effects of halquinol on the intestinal microbiota and using the newly adopted colon volume of 500 mL.

MRL Comment:

MRLs could not be recommended for halquinol due to the lack of an ADI, incomplete characterization of residues in tissues (particularly liver and kidney) and a lack of data necessary to establish reliable MR:TRR ratios over time for calculation of total residues in tissues.