FLUAZURON
Overview
Chemical Names
3-[3-(3-CHLORO-5-TRIFLUOROMETHYL-2-PYRIDINYLOXY)-4-CHLOROPHENYL]-1-(2,6-DIFLUOROBENZOYL)-UREA; N-(3-(3-CHLORO-5-TRIFLUOROMETHYL-2-PYRIDINYLOXY)-4-CHLOROPHENYL)-1-2,6-DIFLUOROBENZOYL)-UREA
Functional Class
Veterinary Drug
INSECTICIDE
INSECTICIDE
Evaluations
Evaluation year: 1998
ADI:0-0.04 mg/kg bw
ADI:
0-0.04 mg/kg bw
Comments:
The Committee established an ADI of 0-40 µg/kg bw (rounded to one significant figure) for fluazuron on the basis of the NOEL of 4.3 mg/kg bw/day for pathological changes in the uterus in the two-year study in mice and a 100-fold safety factor.
MRL Comment:
MRLs (in mg/kg): Muscle (cattle): 0.2; Liver and kidney (cattle): 0.5; Fat (cattle): 7
MRL Code:
MRL
Intake:
TMDI: 0.606 mg/p/d fluazuron equivalents
Meeting:
48
Report:
Tox Monograph:
Residues:
Toxicological study
Pivotal Study:
2-year GLP-compliant carcinogenicity study (Bachmann et al., 1991a): Tif: MAGf (SPF) mice (60/sex/dose) were fed diets containing technical-grade fluazuron at doses of 0, 40, 400, 4000, or 9000 mg/kg feed for two years (0, 4.5, 45, 450, or 990 mg/kg bw/day (males) and 0, 4.3, 43, 430, or 970 mg/kg bw/day (females)). Water consumption was increased in females at
> 40 mg/kg feed. Tumour incidences were not increased in any dose group. Treatment-related non-neoplastic changes included: increased incidence of cataract of the crystalline lens in both sexes and a trend to increased diffuse prostate hyperplasia at 4000 and 9000 mg/kg feed. In addition, non-dose related uterine changes were noted as follows: increased incidences of inflammatory polyps (> 40 mg/kg feed), increased dilatation of the lumen (4000 & 9000 mg/kg feed), and increased incidences of haematomas and dilatation of blood vessels associated with thrombosis (9000 mg/kg feed). On the basis of the pathological changes in the uterus, the NOEL was 40 mg/kg feed, equal to 4.3 mg/kg bw per day.
Animal Specie:
Mice
Effect:
Uterine pathology
NOEL:
4.3 mg/kg bw/day
Point of departure:
4.3 mg/kg bw/day