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CAS number: -
- Table 2: Summary of Micronucleus Test Results
Dose mg/kg b.w.
Sampling time (h)
PCEs with micronuclei (%)
PCE per 2000 erythocytes
2 - 4
- Table 3: Statistical significance at the five per cent level (p
< 0.05, evaluated by means of the non-parametric Mann-Whitney test).
Vehicle control versus test group
500 mg FAT 40849/A TE/kg b.w.; 24 h
1000 mg FAT 40849/A TE/kg b.w.; 24 h
2000 mg FAT 40849/A TE/kg b.w.; 24 h
40 mg CPA/kg b.w.; 24 h
2000 mg FAT 40849/A TE/kg b.w.; 48 h
- = not significant
+ = significant
- Table 4: Historical controls from 2003 - 2009
Negative Controls Males
Positive Controls (CPA) Males
Mean* ± SD
0.10 ± 0.04
2.33 ± 0.70
0.01 - 0.22
0.70 - 4.52
No. of Experiments
*: mean value (percent micronucleated cells)
**: range of the mean group values (percent micronucleated
The test item FAT 40849/A TE was assessed in the micronucleus assay for
its potential to induce micronuclei in polychromatic erythrocytes (PCE)
in the bone marrow of the mouse according to OECD TG 474.
The test item was formulated in 1 % carboxymethylcellulose (CMC), 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 analysis.
Seven males per test group were evaluated for the occurrence of
micronuclei. Per animal 2000 polychromatic erythrocytes (PCEs) were
scored for micronuclei. To describe 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 bw; 48 h preparation interval: 2000 mg/kg bw.
As estimated by pre-experiments 2000 mg FAT 40849/A TE per kg b.w. (the
maximum guideline-recommended dose) was suitable.
The mean number of polychromatic erythrocytes was not decreased after
treatment with the test item as compared to the mean value of PCEs of
the vehicle control indicating that FAT 40849/A TE did not have any
cytotoxic properties in the bone marrow. However, the animals showed
discoloured urine after treatment with at least 1000 mg/kg bw indicating
the bioavailability of the test item.
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 FAT 40849/A TE were near to
the value of the vehicle control group. Additionally the values of all
test item treated animals were within the range of the historical
vehicle control data.
40 mg/kg bw cyclophosphamide administered orally was used as positive
control which showed a statistically significant increase of induced
In conclusion, it can be stated that during the study described and
under the experimental conditions reported, the test item did not induce
micronuclei as determined by the micronucleus test in the bone marrow
cells of the mouse.
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