Pesticide residues in food — 2007: Toxicological ... - ipcs inchem

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Levels relevant to risk assessment
Species Study Effect NOAEL LOAEL
Mouse
Rat
Two-year studies of toxicity
and carcinogenicity a Toxicity 100 ppm, equal to
15 mg/kg bw per day
Carcinogenicity 300 ppm, equal to
46 mg/kg bw per day
Two-year studies of toxicity Toxicity 300 ppm, equal to
and carcinogenicity a 14 mg/kg bw per day
Carcinogenicity 300 ppm, equal to
14 mg/kg bw per day
Multigeneration study of Parental toxicity 250 ppm, equivalent to
reproductive toxicity ae 17 mg/kg bw per day
300 ppm, equal to
46 mg/kg bw per day
1000 ppm, equal to
153 mg/kg bw per day
1000 ppm, equal to
48 mg/kg bw per day
1000 ppm, equal to
48 mg/kg bw per day
750 ppm, equivalent to
50 mg/kg bw per day
Offspring toxicity 12.5 mg/kg bw per day 250 ppm, equivalent to
17 mg/kg bw per day
Developmental toxicity b,e Maternal toxicity 100 mg/kg bw per day 125 mg/kg bw per day
Embryo/fetotoxicity 12.5 mg/kg bw per day 37.5 mg/kg bw per day
Rabbit Developmental toxicity b,e Maternal toxicity — 125 mg/kg bw per day f
Embryo/fetotoxicity 750 mg/kg bw per day 1000 mg/kg bw per day
Monkey Developmental toxicity b,e Maternal toxicity 125 mg/kg bw per day c —
Embryo/fetotoxicity 125 mg/kg bw per day c —
Dog
Six-month and 1-year
studies of toxicity d
a
Dietary administration.
b
Gavage administration.
c
Highest dose tested.
d
Capsule administration.
e
More than one study combined.
f
Lowest dose tested.
Emesis, soft faeces,
increased alkaline
phosphatase activity
100 mg/kg bw per day 500 mg/kg bw per day
Estimate of acceptable daily intake for humans
0–0.1 mg/kg bw
Estimate of acute reference dose
0.1 mg/kg bw
Information that would be useful for the 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 procymidone
Absorption, distribution, excretion and metabolism in mammals
Rate and extent of oral absorption
Dermal absorption
Distribution
Potential for accumulation
Rate and extent of excretion
Metabolism in animals
Rapid, C max
2–8 h; extensive, > 80% excreted in the urine
4% concentrate, 13% for dilution in rats in vivo
Extensive, highest concentrations in fat
Low
Rapid, > 80% in 24 h; enterohepatic recirculation in rats
Hydroxylation, oxidation and conjugation. Some species
differences.
PROCYMIDONE 349–401 JMPR 2007