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EC number: 205-381-9
CAS number: 139-89-9
At 1.5 years survival in all groups ranged from 62 to 86%. Within the
last half year of the study deaths were more frequent, however this was
not an effect of the treatment (average survival in the 250 mg/kg bw
dose group: 61%; in the control 45%)
- No significant abnormalities or differences in behavior or appearance
of the rats in any of the generations or among the various dose levels
- Growth in all groups and in all four generations proceeded at a normal
rate, plateauing at about 1 year. In the F0 generation the growth
responses within sexes at all levels were essentially equal up to the
76th week. During the final half-year the average body weights varied
somewhat more because of premortal losses and deaths, but no significant
variations occurred in the intergroup relationships. Growth data for the
F1, F2, and F3 generation rats in the control and highest dosage test
groups was as good as or better than that of the control group.
- The hemoglobin, hematocrit, and red blood cell counts all fell within
normal ranges up to 1 year. Following this there was a slight downward
trend in hemoglobin and red blood cells with advancing age in all
groups, including the controls, but there were no dose-related
differences. The total and differential leukocyte counts likewise
disclosed no effects attributable to the test material. Prothrombin
times, determined at 78 and 104 weeks in both the responses in both the
250 mg/kg bw group and the control were in the normal range as well as
blood sugar, nonprotein nitrogen and serum calcium levels.
- Sometimes poor performance (see table 1) however they were not dose
- No significant differences were found for the liver, kidneys, spleen,
heart, adrenals, gonads or thyroid glands.
By virtue of their diverse character and sporadic distribution among the
groups the gross pathologic findings were considered not to be causally
related to test dosage. Pulmonary changes were typical of the
respiratory infection common in laboratory rats and their frequency in
the test groups was, for the most part, less than in the controls. Liver
abnormalities also correlated with occurred at least as frequently in
the control as in the test groups. Except for mammary tumors which are
fairly common in females with variance a history of continuous breeding,
the character and number of tumors observed indicated them to be of an
incidental nature. They occurred with a frequency comparable to that
usually seen in this colony.
Microscopically, no important aberrations were evident in the liver.
kidneys, gastrointestinal tract, and tibias of the four rats in each
group selected for sacrifice either at 12 weeks or at 1 year. In the
250-mg/kg bw group, in which 13 organs and tissues of each rat were
examined, the findings were consistently negative.
In the histopathologic examinations of the F0 generation rats sacrificed
at 2 years revealed changes in the anterior pituitaries (focal
hyperplasia); adrenal cortex (focal hyperplasia); medulla (focal
hyperplasia) and liver. However, they were not dose related.
Table 1: Reproduction and lactation data for four generations of rats
F.I. = Fertility Index = (pregnancies/mating) x 100
G.I. = Gestation Index = (litters born/pregnancies) x 100
V.I. = Viability Index = (pups alive at 4 days/pups born) x 100
L.I. = Lactation Index = (pups weaned/pups alive at 4 days) x 100
RESULTS OF ADDITIONAL TESTS
- The tibias of rats sacrificed at the 12-week period showed no evidence
of abnormal calcification.
- At the end of the 2-year period, the ash content of the tibias in the
control and 250-mg/kg groups were approximately the same.
- There was no difference in either the incidence or severity of dental
- There were no significant differences in the two metallo-enzymes blood
carbonic anhydrase and liver xanthine oxidase
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