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EC number: 700-891-2
CAS number: -
Table 2: Effects at blood biochemistry
Table 3: Quantitative effects on sperm
Table 4: Qualitative effects on sperm
The test item was administered once daily by gavage to
rats at the dose-levels of 100, 300 or 1000 mg/kg/day for 4 weeks.
No treatment-related effects were observed on mean body
weight gain, food consumption, Funtional Observation Battery or
hematology and no adverse clinical signs were recorded. There were no
effects on female estrous cycles.
Cholesterol and triglycerides levels were increased in
male and female groups treated at 300 and 1000 mg/kg/day and urea levels
were also higher at 1000 mg/kg/day. These effects, being observed in
both males and females, were considered to be treatment-related and
adverse (Study director's opinion, see conclusion of CSR authors above).
Sperm analysis of the left testis and epididymis revealed
a decreased epididymal sperm count and a lower percentage of
morphologically normal sperm at all dose-levels. This could indicate an
effect on epididymal maturation or testicular-epididymal transport
although no effects were observed at microscopic examination of the
right testis and epididymis and no effects were
observed on the organ weights. Particularly noticable in
the epididymal sperm count was the homogeneity of the results among the
males of each group and the fact that all the test item-treated males
were affected. However the pathologist concluded : in view of the lack
of relationship to dose, and the high incidence of unilateral
spontaneous lesions in the testis and epididymis in this strain of rats,
the decrease in sperm numbers was considered unlikely to be
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