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EC number: -
CAS number: -
E-C104 was repeatedly administered to rats (7/sex/dose) by oral gavage
at dose levels 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 (OECD 422). 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.
In high dose males decreased plasma glucose levels were noted, whereas
in high dose females a decreased plasma triglyceride level was noted.
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 the 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
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