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EC number: 610-522-6
CAS number: 503155-49-5
Lesions observed in the 2 year feeding study
Number of rats started
Number of survivors at 80 weeks
Number received by pathology
Number of males with tumors
Number of females with tumors
Total number of rats with tumors
Tumor type in each rat
Interstitial cell tumor
Combined Repeated Dose and
Carcinogenicity was performed to determine the toxic nature of the test
chemical in Sprague Dawley rats. Two-year tests were run in which 400
male and female Sprague Dawley rats were distributed into various
treatment groups. The treatment groups were - 100 rats/dose (50/sex) and
100 rats/sex for controls. The test chemical (500 mg/kg bw/day, 1000
mg/kg bw/day) was mixed into a commercial laboratory chow diet for each
feeding study. Rats were individually caged. Each animal received in the
Pathology Laboratory was given a careful gross examination, and all
lesions were recorded. Of those not received, most were discarded
because of advanced postmortem autolysis. So far as can be determined,
none of the discarded animals had tumors. Lesions which could not
clearly be identified as neoplastic or non-neoplastic, and tumors, the
type of which was uncertain or uncommon, were also sectioned and
examined microscopically. Tissues sectioned include the following:
liver, lung, heart, spleen, pancreas, stomach, small intestine, colon,
kidney, adrenal, thyroid, testis (or ovary and uterus), leg muscles, leg
bones with included marrow, and any tumor or other unusual condition.
Sections of the mammary glands were also observed for tumors. The
ingestion of the test chemical had no effect on survival, growth, or
weights at autopsy of heart, liver, kidney, spleen, or testes in the
test animals. No effect due to ingestion of the test chemical on either
tumor incidence or tumor type was noted in Sprague Dawley strain on this
two-year experiment. Hence, the No Observed Adverse Effect level was
considered to be 1000 mg/kg bw/day in both male and female Sprague
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