DIMINAZENE

Overview

Chemical Names
4,4'-(DIAZOAMINO)DIBENZAMIDINE DIACETURATE; 1,3-bis(p-AMINOPHENYL)TRIAZENE bis(N- ACETYLGLYCINATE)
Synonyms
DIMINAZENE ACETURATE; AZIDIN; GANASAG; BERENIL
CAS number
908-54-3
Functional Class
Veterinary Drug
TRYPANOCIDE

Evaluations

Evaluation year: 1995

ADI:
0-0.1 mg/kg bw

Comments:
In keeping with general principles for the evaluation of veterinary drugs with a long history of use described at the 40th Meeting of the Committee, an ADI of 0-100 µg/kg bw/day was established for diminazene based on the NOEL of 20 mg/kg bw/day in the nine-month study in dogs and using a 200-fold safety factor. The Committee chose this safety factor to compensate for the inadequacies in the design of the study.
MRL Comment:
MRLs (expressed as parent drug, in mg/kg): Muscle (cattle): 0.5; Liver (cattle): 12; Kidney (cattle): 6; Milk (cattle): 0.15; Fat: no MRL allocated
MRL Code:
MRL
Intake:
TMDI (diminazene equivalents): 6.183 mg/p/d
Meeting:
42
Report: 
TRS 851-JECFA 42/30
Tox Monograph: 
FAS 33-JECFA 42/129
Residues: 
FNP 41/6-JECFA 42/33

Toxicological study

Pivotal Study:
9-month dog study (Scholz & Brunk, 1969): Beagles (3/sex/dose) were given capsules containing 0, 20 or 60 mg/kg bw/day diminazene, 7 days per week for 9 months. One dog of each sex died at the high dose. Bodyweights were also reduced and general condition was poor in high dose males. In animals given 60 mg/kg bw/day diminazene there were foci of softening in the brain stem and cerebellum. There was also testicular atrophy and prostatic dysfunction .
Animal Specie:
Dog
Effect:
Decreased bodyweights, mortality, prostatic malfunction, foci of softening in the brainstem, & testicular atrophy
NOEL:
20 mg/kg bw/day
LOEL:
60 mg/kg bw/day
Point of departure:
20 mg/kg bw/day
Previous Years:
1989, TRS 788-JECFA 34/43, FNP 41/2-JECFA 34/28, FAS 25-JECFA 34/113. NO ADI ALLOCATED. NO MRLs ALLOCATED. NO. O
1989, TRS 788-JECFA 34/43, FNP 41/2-JECFA 34/28, FAS 25-JECFA 34/113. NO ADI ALLOCATED. NO MRLs ALLOCATED. NO. O