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EC number: 200-854-6
CAS number: 75-25-2
The effects of
oral ingestion of the test substance in feed were assessed in a 90-Day
oral gavage study using male and female F344/N rats. The method was
essentially similar to OECD Guideline 408: Repeated Dose 90-Day Oral
Toxicity Study in Rodents; however, a number of endpoints specified in
the guideline were not investigated such as heamatology, clinical
and functional observations.
Rats (10 males
and 10 females per group) were treated with test substance administered
orally by gavage in corn oil 5 days per week for 13 weeks. Test
substance doses were: 0,
12, 25, 50, 100 or 200 mg/kg/ bw.
observed two times per day. Individual
animal weights were recorded once per week. At
the end of the 13-week studies, survivors were killed. Complete
necropsies were performed on all animals.
animals died on the study.
Clinical signs: Lethargy
was noticed in all males that received 100 or 200 mg/kg/bw and all
females receiving 200 mg/kg.
vacuolisation was observed in most male rats (10/10 at 200 mg/kg, 8/10
at 100 mg/kg, 8/10 at 50 mg/kg, 5/10 at 25 mg/kg 6/10 at 12 mg/kg and
3/10 in vehicle controls. This
liver lesion which was not seen in females was characterised by the
presence of well-demarcated vacuoles in the cytoplasm of hepatocytes;
larger vacuoles crowded the nuclei towards the periphery of the cells.
the test substance 5-days per week for 13 weeks resulted in a LOEL of 12
mg/kg/bw for male animals based on hepatocellular vacuolisation. In
females the LOEL was 200 mg/kg/bw based on lethargy observed in the
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