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EC number: -
CAS number: -
E-C104 was repeatedly administered to rats (7/sex/dose) by oral gavage
at dose level 0, 50, 250 and 1000 mg/kg bw/day from 14 days before
mating for 42 days in males and satellite females, and 14 days before
mating through gestation and parturition until day 4 of lactation in
females to determine the effects of repeated exposure and reproductive
and developmental toxicity. Reversibility was studied in satellite
groups for controls and high dose (5/sex/dose). As a result of the test
substance administration, substance-mixed feces (dark blue color) was
noted in all dose groups. Haematological examination showed increases in
platelet count and numbers of neutrophils and lymphocytes. At the end of
the recovery period, increase in reticulocyte number was observed in
males and females showed increase in neutrophils and decrease in
lymphocytes. Clinical biochemistry showed in high dose animals decreased
levels of total bile acids, total cholesterol and ALT. High dose males
showed decreased plasma glucose levels, whereas high dose females showed
a decreased plasma triglyceride level. Gross pathology showed blue
coloration in the GI contents, mesenteric, submaxillary, cervical and
bronchial lymph nodes, lung and kidneys (with no reversibility in
coloration in teh lymph nodes and kidney in the mid- and high dose).
Histopathological examination showed pigment-laden macrophages in the
GI-tract, mesenteric lymph nodes and lungs in rats dosed at and above
250 mg/kg bw/day, but the toxicological relevance is unclear.
No reproduction toxicity and no developmental toxicity was observed.
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