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EC number: 930-690-7
CAS number: -
A short term repeated dose toxicity study was conducted to help inform
on dose selection for a subsequent carcinogenicity study. This
range-finding study was conducted under GLP conditions.
During the study, groups of 10 animals per sex, per dose, received doses
of test material, by oral gavage, 5 days a week. The animals were
observed daily and their behaviour and clinical signs were examined.
Body weights, food and water consumption was measured weekly. During the
sixth week of exposure the animals were killed by exsanguination under
ether anesthesia and blood, urine and tissues were taken for
investigations on standard toxicological parameters. All animals were
subjected to macroscopical examination, organ weights were recorded, and
tissue samples were processed for further histopathological
investigations. In addition, liver enzyme induction was monitored by
EROD (ethoxyresurfin-O-deethylase) activity in plasma.
On the basis of findings from this study, particularly in relation to
effects noted on basal cell hyperplasia in the forestomach as well as
the effects upon liver- and thymus-weight, doses of 3, 10 and 30 mg/kg
bw/day were proprosed for the carcinogenicity study. In order to verify
the observed forestomach proliferation, morphometrical analysis of the
forestomach was incorporated into a 90-day repeated dose toxicity stduy
in rats using the BrdU-incorporation technique (see a robust study
summary under section 7.5.1). This study essentially showed similar
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