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EC number: 406-420-4
CAS number: 69430-40-6
Pilot study/Dose selection
In a preliminary study 12 animals (3 males and 3 females per group) were
dosed orally with 5000 and 3000 mg/kg body weight (groups A and B,
respectively). 1 The animals of group A and B initially showed lethargy
(one animal of group 8 :. also showed piloerection) but recovered all
within one day. Based on the results of this pilot study 5000 mg/kg body
weight was selected as an appropriate dose for the Micronucleus Test.
The mean number of micronuclei scored in the test substance-treated
groups was compared with the corresponding control groups. No increase
in the frequency of micronuclei was observed. The incidence of
micronuclei in the control animals was found to be in the range of
historical data (0.59 +- 0.89; mean + standard deviation, N = 1120). The
groups that were treated with Cyclophosphamide stiowed a decrease in the
ratio of polychromatic to normochromatic erythrocytes, which reflects a
toxic effect of this compound on the erythropoiesis. The positive
control substance induced in both sexes a statistically significant
increase in the number of micronuclei.
It is concluded that this test is valid and that DC 5067 can be
considered as not mutagenic in the Micronucleus Test under the
experimental conditions described in this report.
DC 5067 was tested in the Micronucleus Test in mice. Three groups (A to
F), each comprising 5 males and 5 females, received a single oral dose
of 5000 mglkg body weight. Bone marrow was sampled at 24, 48 and 72
hours after dosing. Corresponding vehicle treated groups (A to C) served
as negative controls. Bone marrow from a positive control group (G),
treated with a single oral dose of cyclophosphamide (CP) at 50 mg/kg
body weight, was harvested at 48 hours after dosing only, The test
substance was found to respond negatively in the Micronucleus Test,
whereas the positive control substance (CP) produced a statistically
significant increase in the incidence of micronuclei in polychromatic
It is concluded that DC 5067 can be considered as not mutagenic in the
Mouse Micronucleus Test under the experimental conditions described in
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