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EC number: 700-960-7
CAS number: 68512-30-1
polychromatic erythrocytes (PCE) and relationship PCE/ total erythrocytes
scoring 48 hours after treatment
dose mg/kg b.w.
micronucleated cells per2000 PCEs per animal
PCE per 2000 erythrocytes
30% DMSO / 70% PEG 400
percent cells with micronuclei
Table2: test item
Novares LS 500
(CAS No 61788-44-1)
Table3: test item
Table4: test item
Table5: positive control
Summary of Micronucleus Test
application before preparation (h)
PCEs with micronuclei (%)
PCE per 2000 erythocytes
at the five per cent level (p < 0.05) was evaluated by means of the
non-parametric Mann-Whitney test.
Vehicle control versus test group
250 mg Novares LS 500 (CAS No 61788-44-1)/kg b.w.
500 mg Novares LS 500 (CAS No 61788-44-1)/kg b.w.
1000 mg Novares LS 500 (CAS No 61788-44-1)/kg b.w.
40 mg CPA/kg b.w.
- = not
+ = significant
n.t. = not
This study was performed
to investigate the potential of Novares LS 500 (CAS No 61788-44-1) to
induce micronuclei in polychromatic erythrocytes (PCE) in the bone
marrow of the mouse.
Novares LS 500 was
administered orally twice at an interval of 24 hours. The test item was
formulated in 30%
dimethylsulfoxide / 70% polyethylene glycol 400, which was
also used as vehicle control; the dose volume was 10 mL/kg b.w.. A
positive control group received cyclophosphamide once at 40 mg/kg b.w..
Forty eight hours after the first administration of the test item (24 h
after the last treatment) the bone marrow cells were collected for
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: 250, 500, and 1000 mg/kg b.w..
The highest dose was
estimated by a pre-experiment to be suitable. As observed in
pre-experimental assessments, at higher dose levels, animals died.
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 Novares LS 500 (CAS No 61788-44-1) did not have any
cytotoxic properties in the bone marrow when given orally in this
experiment. It is considered that the clinical signs and deaths
expressed at doses higher than 1000 mg/kg bw, used in this experiment
indicated that Novares LS 500 was absorbed and that the bone marrow
would have been exposed to 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 Novares LS 500 (CAS No 61788-44-1) were below to
the value of the vehicle control group. Additionally all values were
within the historical vehicle control data base.
administered once orally at 40 mg/kg b.w. was used as positive control,
which showed a statistically significant increase of induced
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