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EC number: 429-600-4
CAS number: 1026988-42-0
The single oral administration of aqua dest. in a volume of 10 ml/kg
body weight led to 1.8% polychromatic erythrocytes containing
micronuclei after the 24-hour sacrifice interval.
After the single administration of the highest dose of 3000 mg/kg body
weight, 2.0% polychromatic erythrocytes containing micronuclei were
found after 16 hours and 1.6% after 24 hours and 48 hours.
In the two lower dose groups rates of micronuclei of about 2.0% (1000
mg/kg group) and 1.5% (333 mg/kg group) were detected after a sacrifice
interval of 24 hours in each case.
With 21.4% the positive control substance cyclophosphamide for
clastogenicity, as expected, led to a clear increase in the number of
polychromatic erythrocytes containing mainly small micronuclei at a dose
level of 20 mg/kg body weight.
With 46.8% the positive control vincristine for spindle poison effects
also led to a clearly enhanced number of micronuclei containing
polychromatic erythrocytes with the expected amount of large
micronuclei, i.e. 10.6%.
The single oral administration of the solvent in a volume of 10 ml/kg
body weight was tolerated by all animals without any signs or
symptoms.Doses of 3000 mg/kg and 1000 mg/kg led to irregular
respiration, piloerection and squatting posture about 30minutes after
test substance administration; in a few cases the general state of the
animals was poor. After about 2 hours some animals had closed eyelids. 3
animals died 4 hours and 1 animal the day after treatment of 3000 mg/kg
body weight. After administration of 333 mg/kg body weight only
irregular respiration and piloerection were observed.The urine of the
animals of all test groups was colored orange or brownish. Neither the
single administration of the positive control substance cyclophosphamide
in a dose of 20 mg/kg bodyweight nor that of vincristine in a dose of
0.15 mg/kg body weight caused any evident signs of toxicity.
According to the results of the present study, the single oral
administration of Basazol Gelb 8511in doses of 3000 mg/kg, 1000 mg/kg
and 333 mg/kg body weight did not lead to any increase in the number of
polychromatic erythrocytes containing either small or large micronuclei.
The rate of micronuclei was always in the same range as that of the
negative control in all dose groups and at all sacrifice intervals.
No inhibition of erythropoies is determined from the ratio of
polychromatic to normochromatic erythrocytes was detected.
Thus, under the experimental conditions chosen here, the test substance
Basazol Gelb 8511does not have any chromosome-damaging (clastogenic)
effect, and there were no indications of any impairment of chromosome
distribution in the course of mitosis.
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