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EC number: 939-253-5
CAS number: 68424-85-1
study was conducted to determine the repeated dose oral toxicity of the
test substance (ca. 80% purity) according to OECD Guideline 408 and US
EPA OPP 82 -1, in compliance with GLP. This sub-chronic oral toxicity
study (90 d) was realised in Sprague-Dawley rats. The rats were
administered daily dietary levels of 0, 100, 500, 1000, 4000 and 8000
ppm test substance, equivalent to 0, 6, 31 and 62 mg/kg bw/d (i.e. 0,
4.8, 25 and 50 mg a.i./kg bw/d) (males) and 0, 8, 38 and 77 mg/kg
bw/d (i.e. 0, 6.4, 30 and 62 mg a.i./kg bw/d) (females) for 95 and 96
days, respectively. Daily intakes at 4000 and 8000 ppm could not be
calculated due to high mortality. The animals were observed for
mortality, clinical signs, body weight, food consumption, hematology and
clinical chemistry at termination. Gross and histopathological
examinations were also performed. A slight trend in reduction of body
weight and food consumption in males at 1000 ppm was observed. Besides
this, there were no treatment-related findings at 1000 ppm or lower.
There was 80 and 100% mortality at 4000 and 8000 ppm, respectively.
Clinical signs of toxicity (general cachexia and loose faeces),
decreased food consumption and body weights, gross necropsy findings
(including increased amounts of liquids or semi-solid material within
the stomach, jejunum, ileum and cecum) were also observed at 4000 and
8000 ppm. The cause of morbidity and death was assumed to be shock
secondary to fluid and/or ionic shifts in the gastro-intestinal tract.
Under the study conditions, the NOAEL was considered to be 500 ppm in
the diet, equivalent to 31 mg/kg bw/d (i.e. 25 mg a.i./kg bw/d) for
males and 38 mg/kg bw/d (i.e. 30 mg a.i./kg bw/d) for females (Van
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