Pesticide residues in food — 2006: Toxicological ... - ipcs inchem

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Multigeneration study of
reproductive toxicity a
Carcinogenicity
Parental toxicity
Offspring toxicity
160 ppm, equal to —
9.7 mg/kg bw per day c
20 ppm, equal to
1.5 mg/kg bw per day
200 ppm equal to
15.3 mg/kg bw per day
80 ppm, equal to
6.1 mg/kg bw per day
Developmental toxicity b Maternal toxicity 10 mg/kg bw per day 100 mg/kg bw per day
Embryo/fetotoxicity 500 mg/kg bw per day c —
Rabbit Developmental toxicity b Maternal toxicity 200 mg/kg bw per day c __
Embryo-fetotoxicity 200 mg/kg bw per day —
Dog 90-day study of toxicity a Toxicity 40 ppm, equal to
0.9 mg/kg bw per day
One-year study of toxicity a Toxicity 40 ppm, equal to 1.0
mg/kg bw per day
a
Dietary administration
b
Gavage administration
c
Highest dose tested
400 ppm, equal to
10.4 mg/kg bw per day
400 ppm, equal to
8.9 mg/kg bw per day
Estimate of acceptable daily intake for humans
0–0.01 mg/kg bw
Estimate of acute reference dose
Unnecessary
Information that would be useful for continued evaluation of the compound
Results from epidemiological, occupational health and other such observational studies of
human exposure
Critical end-points for setting guidance values for exposure to bifenazate
Absorption, distribution, excretion, and metabolism in mammals
Rate and extent of oral absorption
Distribution
Potential for accumulation
Rate and extent of excretion
Metabolism in animals
Toxicologically significant compounds
Moderate and incomplete; maximum blood concentration reached
by 5–6 h; later at higher doses. Approximately 79–85% and 22–29%
absorbed within 72 h at 10 and 1000 mg/kg bw, respectively
Widely distributed in tissues
No evidence of significant accumulation
Approximately 90% (27% in urine and 63% in faeces) within 48 h at
10 mg/kg bw per day
Extensive; metabolic pathways include hydrazine oxidation,
demethylation, ring hydroxylation, cleavage of the hydrazine-carboxylic
acid portion of the molecule and conjugation with glucuronic acid and
sulfate
Bifenazate and bifenazate-diazene (compounds readily interconvert)
BIFENAZATE X-X JMPR 2006