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EC number: 214-881-6
CAS number: 1205-17-0
Table 1: Summary of Bone Marrow Micronucleus Study
No. of Mice
PCE/Total Erythrocytes (Mean ± SD)
Change from Control (%)
Micronucleated Polychromatic Erythrocytes
No./1000 PCEs (Mean ± SD)
0.483 ± 0.04
0.3 ± 0.27
0.568 ± 0.03
0.9 ± 0.55
0.487 ± 0.11
0.1 ± 0.22
0.549 ± 0.04
0.6 ± 0.22
0.535 ± 0.04
0.5 ± 0.00
0.529 ± 0.04
0.4 ± 0.42
0.546 ± 0.06
0.536 ± 0.05
0.5 ± 0.35
0.571 ± 0.05
25.6 ± 5.24
0.549 ± 0.09
18.3 ± 6.47
0.615 ± 0.04
0.2 ± 0.27
0.553 ± 0.03
0.3 ± 0.45
0.540 ± 0.07
0.0 ± 0.00
0.554 ± 0.04
0.5 ± 0.50
*p≤0.05 (Kastenbaum-Bowman Tables)
A mammalian erythrocyte micronucleus test in ICR mice was conducted to
assess the toxicity of the test material using a protocol written to
comply with the standardised guideline OECD 474 under GLP conditions.
The assay was performed in two phases. The first phase, designed to set
dose levels for the definitive study, consisted of a pilot toxicity
study followed by a toxicity study and supplemental toxicity study. The
second phase, the micronucleus study, evaluated the potential of the
test material to increase the incidence of micronucleated polychromatic
erythrocytes in bone marrow of male and female mice. In both phases of
the study, test and control materials were administered in a constant
volume of 20 mL/kg body weight through single intraperitoneal injection.
Corn oil was determined to be the solvent of choice based on
compatibility of the vehicle with the test system animals..
In the pilot toxicity study, male mice were dosed with 1, 10, 100 or
1000 mg test material/kg body weight and male and female mice were dosed
with 2000 mg/kg (5 animals per sex per dose level). Mortality was
observed in 5/5 male mice and 5/5 female mice at 2000 mg/kg. Clinical
signs following dose administration included lethargy, piloerection,
crusty eyes and irregular breathing in all males at 1000 mg/kg and
convulsions in all males and females at 2000 mg/kg.
In the toxicity assay, male and female mice were dosed with 1200, 1400,
1600 or 1800 mg test material/kg body weight (5 animals per sex per dose
level). Mortality was observed in 4/5 male mice and 5/5 female mice at
1200 mg/kg and in all males and females at 1400, 1600 and 1800 mg/kg.
Clinical signs following dose administration included convulsions in all
animals at all dose levels and prostration, irregular breathing and
crusty eyes in males and females at 1200, 1400, 1600 and 1800 mg/kg.
Lethargy and piloerection were observed in one surviving animal at 1200
mg/kg. Due to high mortality at 1200 mg/kg and clinical signs at 1000
mg/kg (pilot study), a supplemental toxicity study was performed using
the test material at a dose level of 1000 mg/kg.
In the supplemental toxicity study, male and female mice were dosed with
1000 mg test material/kg body weight (5 animals per sex per dose level).
Mortality was observed in 2/5 female mice. Clinical signs following dose
administration included prostration, irregular breathing, crusty eyes,
tremors, lethargy and piloerection in males and females at 1000 mg/kg.
The high dose for the micronucleus test was set at 725 mg/kg which was
estimated to be approximately 70 % of the LD50/3.
In the micronucleus assay, male and female mice were dosed with 0, 181,
362 or 725 mg test material/kg body weight (15 animals per sex per
dose). A concurrent positive control group was dosed with
cyclophosphamide. Mortality was observed in 1/15 female mice receiving
725 mg/kg. Clinical signs following dose administration included
lethargy and piloerection in male and female mice at 362 and 725 mg/kg
and prostration and irregular breathing in males and females at 725
mg/kg. Bone marrow cells, collected 24 and 48 hours after treatment (5
animals per sex per dose per time interval), were examined
microscopically for micronucleated polychromatic erythrocytes. Slight
reductions (up to 12 %) in the ratio of polychromatic erythrocytes to
total erythrocytes were observed in some of the test material-treated
groups relative to the respective vehicle controls. These reductions
suggest that the test material did not inhibit erythropoiesis. No
significant increase in micronucleated polychromatic erythrocytes in
test material-treated groups relative to the respective vehicle control
groups was observed in male or female mice at 24 or 48 hours after dose
CP induced a significant increase in micronucleated polychromatic
erythrocytes in both male and female mice.
Under the conditions of the study, the test material did not induce a
significant increase in the incidence of micronucleated polychromatic
erythrocytes in bone marrow and was concluded to be negative in the
micronucleus test using male and female mice.
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