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EC number: 228-250-8 | CAS number: 6197-30-4
The single oral administration of the vehicle in a volume of 10 ml/kg body weight was tolerated by all animals without any signs or symptoms. Doses of 500 mg/kg , 1000 mg/kg or 2000 mg/kg body weight led to piloerection about 15 minutes after treatment which lasted for about 2 hours. Neither the single administration of the positive control substance cyclophosphamide in a dose of 20 mg/kg body weight nor that of vincristine in a dose of 0.15 mg/kg body weight caused any evident signs of toxicity.
Remark: The unit"per mille" used in the original study report has been converted to "per cent" in this freetext due to editorial reasons.
The single oral administration of olive oil in a volume of 10 ml/kg body weight led to 0.13% polychromatic erythrocytes containing micronuclei after the 24 -hour sacrifice interval. After the single administration of the highest dose of 2000 mg/kg body weight, 0.2% polychromatic erythrocytes containing micronuclei were found after 16 hours, 0.15% after 24 hours and 0.13% after 48 hours. In the two lower dose groups rates of micronuclei of about 0.19% (1000 mg/kg group) and 0.13% (500 mg/kg group) were detected after a sacrifice interval of 24 hours in each case.
With 1.54% 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 6.04% 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. 1.48%.
The number of normochromatic erythrocytes (NCEs) containing micronuclei did not differ to any appreciable extent in the negative control or in the various dose groups at any of the sacrifice intervals. An amount of about 0.33% (p<0.05) in the highest dose group must be regarded as an incidental finding and cannot be related to the test substance treatment due to the short sacrifice interval of 24 hours at which the NCEs had already past the sensitive stage at the time of treatment. Furthermore, there is no corresponding finding in polychromatic erythrocytes. Thus, the test substance Uvinul N 538 did not lead to any increase in the rate of micronuclei.
The number of normochromatic or polychromatic erythrocytes containing small micronuclei (d<D/4) did not deviate from the solvent control value at any of the sacrifice intervals. Nor were large micronuclei (d>D/4) observed either in the negative control group or in the three dose groups. No inhibition of erythropoiesis induced by the treatment of mice with Uvinul N 539 was detected; the ratio of polychromatic to normochromatic erythrocytes was always in the same range as that of the control values in all dose groups.
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