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EC number: 202-374-2
CAS number: 94-91-7
The test item
Alpha,alpha`-Propylenedinitrilodi-o-cresol was assessed in the
micronucleus assay for its potential to induce micronuclei in
polychromatic erythrocytes (PCE) in the bone marrow of the mouse.
The test item was dissolved in PEG
400, which was also used as vehicle control. The volume administered
orally was 10 mL/kg b.w.. 24 h and 48 h after a single administration of
the test item the bone marrow cells were collected for micronuclei
Seven males per test group (except the
vehicle and positive control groups with 5 males only) were evaluated
for the occurrence of micronuclei. Per animal 2000 polychromatic
erythrocytes (PCEs) were scored for micronuclei. For the high dose group
(24h) only six males were evaluated for the occurrence of micronuclei,
as one mouse died intercurrently. To investigate a cytotoxic effect due
to the treatment with the test item the ratio between polychromatic and
normochromatic erythrocytes was determined in the same sample and
reported as the number of PCEs per 2000 erythrocytes.
The following dose levels of the test
item were investigated:
24 h preparation interval: 500, 1000,
and 2000 mg/kg b.w.
48 h preparation interval: 2000 mg/kg b.w.
The highest dose was estimated by a
pre-experiment to be suitable.
After treatment with the test item at
48h preparation interval the number of PCEs was not substantially
decreased as compared to the mean value of PCEs of the vehicle control
thus indicating that Alpha,alpha`-Propylenedinitrilodi-o-cresol did not
induce cytotoxic effects in the bone marrow. However, one animal (no.
21) of the highest dose group showed clinical signs and died
approximately 24h after administration indicating systemic exposure.
In comparison to the corresponding
vehicle controls there was no statistically significant or biologically
relevant enhancement in the frequency of the detected micronuclei at any
preparation interval and dose level after administration of the test
item. The mean values of micronuclei observed after treatment with
Alpha,alpha`-Propylenedinitrilodi-o-cresol were below or near to the
value of the vehicle control group. Additionally, no dose dependent
increase in the frequency of detected micronuclei was observed with
increasing dosages and all values in dose groups were very well within
the laboratory’s historical vehicle control data.
40 mg/kg b.w. cyclophosphamide
administered orally was used as positive control which showed a
statistically significant increase of induced micronucleus frequency.
In conclusion, it can be stated that
during the study described and under the experimental conditions
reported, the test item Alpha,alpha`-Propylenedinitrilodi-o-cresol
did not induce micronucleias determined by the micronucleus test in
the bone marrow cells of the mouse.
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