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EC number: 229-722-6
CAS number: 6683-19-8
MINIMUM ACHIEVED DOSAGE (Table 1)
The mean intake of test substance (mg/kg body weight/day) during the 104
week treatment period
During the complete histopathological investigation performed in 1985
(see above), the following additional observations were reported:
The incidence of pancreatic islet cell adenomas, in male rats from the
10,000 ppm dosage group was slightly above that of the control
group (Table 1 ). However, the increase was not statistically
significant (Appendix 2) and considered unlikely to be of biological
importance. No effect was seen in female rats. The incidence and
distribution of other neoplasms in this study were within the normal
tumour profile for laboratory maintained rats of this strain. Briefly:
mammary tumours were common in females; pituitary tumours in both sexes;
with a lower incidence of subcutaneous tumours predominantly in males.
No treatment-related changes were detected. Spontaneous changes were
recorded for many organs and were within the normal background range for
rats of this strain, in this laboratory. Among the more common lesions
were: renal progressive glomerulo-nephrosis with parathyroid hyperplasia
and associated metastatic mineralisation in the aorta, heart and
stomach; and occasional osteodystrophia fibrosa of the sternum;
myocardial fibrosis-predominantly in males; foci of altered hepatocytes;
periportal hepatocyte vacuolation - predominantly in females;
vacuolation of the adrenal cortex; cystic degeneration and haemorrhage
of the adrenal cortex - predominantly in females; extra-medullary
haemopoiesis in the spleen - mainly in females; and mammary secretory
activity/galactoceles - also predominantly in females.
FACTORS CONTRIBUTORY TO DEATH
For animals dying, or killed in a moribund condition during the course
of the study, the pathologist attempted to ascertain the major factor(s)
responsible for each individual rat. None of these factors were
considered to be treatment-related. Common factors were pituitary and
mammary tumour - especially in females, subcutaneous tumours in males,
and renal disease - especially in males.
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