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EC number: 245-844-2
CAS number: 23726-93-4
7.6.2/1: Micronucleus data
Vehicle Control (0 mg/kg bw)
250 mg/kg bw
500 mg/kg bw
750 mg/kg bw
20 mg/kg bw
0.15 mg/kg bw
Total No. of PCEs
Total No. of NCEs
MN in PCEs (%)
MN in NCEs (%)
: Statistically significant (Wilcoxon test, one-sided) vs. Vehicle
control group, p<= 0.05
Statistically significant (Wilcoxon test, one-sided) vs. Vehicle control
group, p<= 0.01
- The administration of the test substance
at 250, 500 and 750 mg/kg bw led to squatting posture, poor general
state and irregular respiration.
an in vivo bone marrow micronucleus test, performed according to
OECD guideline 474 (1997
and in compliance with GLP, Crl:NMRI mice (5 males/dose) were
administered once intraperitoneally with test material, dissolved in
olive oil, at the dose levels of 250, 500 and 750 mg/kg bw in a volume
of 10 mL/kg bw. Vehicle control group was administered with olive oil
and positive control groups were given cyclophosphamide (20 mg/kg bw)
and vincristine (0.15 mg/kg bw) by the same route. Animals were
sacrificed and the bone marrow of the femurs was prepared 24 and 48 h
after administration in the 750 mg/kg bw dose group and in the vehicle
controls. In the test groups of 250 and 500 mg/kg bw and in the positive
control groups, only 24 h sacrifice interval was investigated. After
staining of the preparations, 2000 polychromatic erythrocytes (PCEs)
were evaluated per animal and investigated for micronuclei. The
normocytes (NCEs) with and without micronuclei occurring per 2000
polychromatic erythrocytes were also recorded. Range-finding test was
conducted to determine the dose levels for main study.
material did not lead to any increase in the number of PCEs containing
either small or large micronuclei. The rate of micronuclei was always
close to the range as that of the concurrent vehicle controls in all
dose groups and at all sacrifice intervals and within the range of the
historical control data. No inhibition of erythropoiesis determined from
the ratio of PCE/NCE was detected. Both of the positive control
chemicals, i.e. cyclophosphamide for clastogenicity and vincristine for
spindle poison effects, led to the expected increase in the rate of
polychromatic erythrocytes containing small or large micronuclei
indicating the validity of the study.
the test conditions, test material is not classified as clastogenic or
aneugenic according to the criteria of the Annex VI of the of the
Regulation (EC) No.1272/2008 (CLP).
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