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

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398<br />

Rat, LC 50<br />

, <strong>in</strong>halation<br />

Rabbit, sk<strong>in</strong> irritation<br />

Rabbit, eye irritation<br />

Gu<strong>in</strong>ea-pig, sk<strong>in</strong> sensitization (test<br />

method used and result)<br />

Short-term studies of toxicity<br />

Target/critical effect<br />

> 3.4 mg/l of air (maximum achievable concentration)<br />

Not irritat<strong>in</strong>g<br />

Slight irritant<br />

Positive <strong>in</strong> maximization test, negative <strong>in</strong> Buehler test<br />

Food consumption/body-weight ga<strong>in</strong>; liver (rats, mice, dogs); haematological<br />

effects (dogs)<br />

20 mg/kg bw per day (1-year study <strong>in</strong> dogs)<br />

714 mg/kg bw per day (28-day, 20 exposures, rats)<br />

Negative <strong>in</strong> a battery of tests <strong>in</strong> vitro and <strong>in</strong> vivo. No genotoxic potential.<br />

Lowest relevant oral NOAEL<br />

Lowest relevant dermal NOAEL<br />

Genotoxicity<br />

Long-term studies of toxicity and carc<strong>in</strong>ogenicity<br />

Target/critical effect (rats) Kidney & liver weight (both sexes) and glomerulonephrosis (males); body weight.<br />

Lowest relevant NOAEL/NOEL 20 mg/kg bw per day (2-year study <strong>in</strong> rats)<br />

Carc<strong>in</strong>ogenicity<br />

No evidence of treatment related tumorigenicity <strong>in</strong> rats or mice<br />

Reproductive toxicity<br />

Reproduction target/critical effect No effects on reproductive <strong>in</strong>dices<br />

Reduction <strong>in</strong> body-weight ga<strong>in</strong> <strong>in</strong> offspr<strong>in</strong>g dur<strong>in</strong>g lactation<br />

Lowest relevant reproductive 20 mg/kg bw per day (parents and offspr<strong>in</strong>g)<br />

NOAEL<br />

110 mg/kg bw per day (r eproduction)<br />

Developmental target/critical effect<br />

Lowest relevant developmental<br />

NOAEL<br />

Neurotoxicity / delayed neurotoxicity<br />

Acute neurotoxicity<br />

12-month i nvestigation of neurotoxicity<br />

with<strong>in</strong> a long-term study<br />

<strong>in</strong> rats<br />

Other toxicological studies<br />

Induction of liver xenobiotic<br />

m etaboliz<strong>in</strong>g enzymes (2-week<br />

dietary study)<br />

Medical data<br />

No specific fetal effects<br />

80 mg/kg bw per day (maternal toxicity <strong>in</strong> rabbits).<br />

80 mg/kg bw per day (fetal effects)<br />

No adverse effects<br />

No neurotoxic effects.<br />

NOAELs: 45 mg/kg bw per day (rats); 55 mg/kg bw per day (mice)<br />

Sensitization <strong>in</strong> production-plant personnel. No other adverse effects r eported.<br />

Summary<br />

Value Study Safety factor<br />

ADI 0–0.2 mg/kg bw Rat, 2-year study;<br />

100<br />

dog, 1-year study;<br />

rat, study of reproductive toxicity<br />

ARfD Unnecessary — —<br />

QUINOXYFEN X-X JMPR <strong>2006</strong>

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