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EC number: 425-240-7
CAS number: -
An increase in testes and epididymides weight in males of all dose
groups did not follow a dose-relationship and was furthermore without a
histopathological correlate. Therefore the toxicological significance of
this observation was regarded as uncertain.
Without further corroborating findings statistically significant
decreased or increased values for hematology or clinical biochemistry
were considered to be of uncertain toxicological significance.
Analysis of the divalent metal contents of the formulation samples
indicated that measured concentrations were significantly lower than the
nominal concentrations. None of the data generated during the
preparation of the formulations provided an explanation of the low
measured levels of metals. Losses of settlements prior to final analysis
may have occurred, alternatively, weakness of the ICP-AES technique was
indicated. The author concluded, that the dose formulation records
provide a more reliable indicator of doses to which the test animals
were exposed; nominal dosage were therefore believed correct, and only
theses were discussed elsewhere in the report.
A subacute (28 days) toxicity study according to EU Method B.7 was
conducted with the test substance administered once daily in nominal
doses of 0 (vehicle control), 15, 150 and 1000 mg/kg bw to 5 male and 5
female animals per dose-group.
There were no deaths and no clinical signs observed during the study.
The body weight and food consumption of the treated animals was
generally comparable to the controls. Minor haematological disturbances
seen in rats dosed at 1000 mg/kg (haemolglobin levels and clotting times
in males, lymphocyte and neutrophil counts in females) were considered
to be of uncertain toxicological significance. Small decreases in plasma
alanine and aspartate aminotransferase also seen at this test dosage
were also not indicative of toxic effect. There were no changes in organ
weights, macroscopic and microscopic examinations that were considered
to be an effect of treatment. Overall, no clear indication for systemic
availability could be concluded from the study. The NOAEL of the study
was set 1000 mg/kg bw.
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