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EC number: 485-350-6
CAS number: 405095-33-2
Table 1: Results of pre-experiment
0 – 1
2 – 4
5 – 6
1st Pre-experiment: 1000 mg/kg bw; 2 males / 2 females
The experiment was
stopped approx. 24 h
after application and the
remaining male animal
Slightly reduced spontaneous activity
Burrows itself in the bedding
2nd Pre-experiment: 500 mg/kg bw; 2 males / 2 females
* male No. 1 was euthanized in moribund condition (lateral posture,
coma, salivation, hind legs and testis cyanotic)
Table 2: Clinical examination results of the main experiment
Hours post-treatment (males)
0 - 1
2 - 4
5 - 6
High dose: 500 mg/kg bw (14 males at 1 to 24 h; 7 males at 48 h)
Partially closed eyes
Medium dose: 250 mg/kg bw (7 males)
Low dose: 125 mg/kg bw (7 males)
Table 3: Summary of Micronucles Test Results
Dose [mg/kg bw]
Mean MN/4000 PCE
SD MN/4000 PCE
Ratio PCE/total Ery
% ratio Vehicle
SD: Standard Deviation
PCE: Polychromatic Erythrocytes
Table 4: Biometry
Negative control versus test group
Dose 1 – 125 mg/kg bw; 24 h
Dose 2 – 250 mg/kg bw; 24 h
Dose 3 – 500 mg/kg bw; 24 h
Positive control – 20 mg CPA/kg bw; 24 h
Dose 3 – 500 mg/kg bw; 48 h
-: not significant
This study was performed to investigate the potential of the test
substance tested as carbonate salt to induce micronuclei in
polychromatic erythrocytes (PCE) in the bone marrow of the rat.
The test item was formulated in DMSO / PEG 400 (3/7), which was also
used as vehicle control. The volume administered orally was 20 mL/kg bw.
The volume of the positive control administered was 10 mL/kg bw.
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 except for the negative and positive control groups with
five animals each. At least 4000 polychromatic erythrocytes (PCEs) per
animals were scored for micronuclei.
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 500
The following dose levels of the test item were investigated:
24 h preparation interval: 125, 250, and 500 mg/kg bw.
48 h preparation interval: 500 mg/kg bw.
The animals treated with the vehicle control did not exhibit any
Clinical symptoms in the main experiment included abdominal posture,
partially closed eyes, slightly reduced spontaneous activity,
salivation, as well as sleepiness. The animals of all dose levels were
The observed systemic toxicity at the tested doses is indicative for a
systemic distribution of the test item. Thus, bioavailability of the
test item under the tested conditions is assumed.
This was additionally confirmed by analytical detection of the test item
The highest dose was estimated by two pre-experiments to be suitable.
A correction factor of 1.36 was applied based on test item purity data
provided by the sponsor.
After treatment with the test item the number of PCEs was not
substantially decreased as compared to the mean value of PCEs of the
vehicle control thus indicating that the test substance tested as
carbonate salt did not exert any cytotoxic effects in the bone marrow.
In comparison to the corresponding vehicle controls there was no
biologically relevant or statistically significant enhancement in the
frequency of the detected micronuclei at any preparation interval after
administration of the test item and with any dose level used.
20 mg/kg bw cyclophosphamide administered orally was used as positive
control which showed a substantial increase of induced micronucleus
In conclusion, it can be stated that under the experimental conditions
reported, the test item tested as carbonate salt did not induce
micronuclei as determined by the micronucleus test with bone marrow
cells of the rat.
Therefore, the test substance tested as carbonate salt is considered to
be non-mutagenic in this micronucleus assay.
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