DIMETRIDAZOLE

Overview

Chemical Names
1,2-DIMETHYL-5-NITROIMIDAZOLE
Synonyms
EMTRYL; EMTRYMIX; EMTRYLVET; UNIZOLE
CAS number
551-92-8
Functional Class
Veterinary Drug
ANTIPROTOZOAL_AGENT

Evaluations

Evaluation year: 1989

ADI:
NO ADI ALLOCATED

Comments:
The results of the three non-GLP long-term rat studies were reported between 1973 and 1977. Dose-related increases in benign mammary tumor incidences were observed in females in all 3 studies, reaching statistical significance in 2 of the studies. Because of the lack of mutagenic effect of dimetridazole in in vitro and in vivo mammalian systems, the mechanism for the production of an increased number of benign mammary tumors in the rat was unlikely to be genotoxic. However, no evidence was submitted to suggest a possible mechanism. Although a NOEL of 100 ppm in the diet, equal to 4 mg/kg bw/day, was reported in one of the long-term rat studies, the Committee could not establish an ADI solely on the basis of this study in the absence of the results of a carcinogenicity study in a second species.
MRL Comment:
No MRLs allocated
MRL Code:
O
Meeting:
34
Report: 
TRS 788-JECFA 34/21
Tox Monograph: 
FAS 25-JECFA 34/33
Residues: 
FNP 41/2-JECFA 34/16