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EC number: 701-281-9
CAS number: -
Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test: OECD 422: NOEL, males: 316 mg/kg body weight, NOEL,females: 870 mg/kg body weight. NOAEL, males and females: 870 mg/kg body weight.
No-observed-effect-level (NOEL) of the test item was at 100 mg per kg
body weight and day for males and at 870 mg/kg for females. The NOAEL
was at 870 mg per kg body weight and day for both sexes.
Only local effects
were noted (minimal
irritation on the mucous membranes of the stomach noted by a
proliferation of the limiting ridge). In
the livers of the high dosed males a centrolobular cytoplasmatic
basophilia of the hepatocytes is interpreted as indicator of an
induction of metabolizing enzymes. As the liver weight was not affected,
the amount of enzyme induction is assumed to be rather low. Enzyme
induction is not taken as an adverse effect, but as an adaptive response.
EU-Directive 2001/59/EC, the application of "R48" is not considered as
necessary for the test item, as no severe toxic effects were noted at
doses of up to 316 mg/kg.
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