SUICALM

Comments:

The Committee considered new studies to address issues concerning potential genotoxicity/carcinogenicity that had been raised at the forty-third meeting. Taking into account the results of all of the genotoxicity studies performed, the Committee concluded that azaperone is unlikely to be genotoxic or carcinogenic. The Committee concluded that the pharmacological effects of azaperone are the most relevant for determining an ADI. An ADI of 0-6 µg/kg bw was established, based on a NOAEL of 630 µg/kg bw for neurobehavioural effects in dogs after oral administration and a safety factor of 100. The MRL values of 60 µg/kg (muscle and fat) and 100 µg/kg (liver & kidney) in pigs for the sum of azaperone & azaperol were not revised.

MRL Comment:

The MRLs recommended at the fiftieth meeting (1999) were not revised. New information on the method of analysis in tissues of pigs was reviewed at the fifty-second meeting. The Committee concluded that insufficient characterization on specificity, accuracy, and reproducibility of the method had been provided. It was recommended that the method be improved and after further development it be forwarded to the Codex Committee on Residues of Veterinary Drugs in Foods for consideration.

MRL Code:

TMRL

Meeting:

52

Report: 

Tox Monograph: 

Residues: 

Previous Years: