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EC number: 232-092-5
CAS number: 7786-17-6
Table 1 Proportion
of Cells with One or More Aberrations
No. of Cells with One or More Aberrations
No. of Normal Cells
Mean Proportion of Aberrant Cells/Animal ± SD
% Aberrant Cells Per Group
0.004 ± 0.008
0.004 ± 0.013
0.014 ± 0.010
0.014 ± 0.021
0.012 ± 0.017
0.014 ± 0.016
0.769 ± 0.095
Chi-square at p≤0.01
Table 2 Mean
No. Metaphases Analysed
Total Aberrations Per Group
Mean Aberrations/Cell ± SD†
3.898 ± 1.603*
from the mean aberrations/cell for each animal in the group.
Table 3 Analysis of
No. Metaphases Scored
Legend to Chromosome
Gaps - They are
achromatic lesions of different lengths along the arm of one chromatid
(gap) or at the same locus of both chromatids (isogap), except for the
secondary constriction on certain chromosomes. They are scored but not
considered chromosomal aberrations.
Del = Deletions (c) - A
simple severance of the chromosome or chromatid that gives an acentric
fragment(s) at telophase.
Inter = Interchange
(c/c) - Exchanges involving two or more lesions situated in the
chromatids of different chromosomes (symmetrical and asymmetrical).
Intra = Intrachanges
(c/c) - Exchanges resulting from lesions within the same chromosome.
Intrachanges are either inter-arm intrachanges (c/c ter) where the
lesions affect both arms of the same chromosome or intra-arm
intrachanges (c/c) where the lesions affect the chromatids of the same
arm of the same chromosome.
Trir = Triradial (i/c)
- Isochromatid/Chromatid breaks which involves two chromosomes or Intra
which involves both arms of the same chromosome.
Del = Deletions -
Include terminal (Term) and interstitial (Int) deletions. Terminal (C)
deletion is the complete severance of the terminal region of a
chromosome, which gives rise to a shortened chromosome and an acentric
fragment, and is not associated with any obvious exchange process. The
acentric fragment may lie free among the chromosomes of the metaphase
spread. Interstitial deletion is the severance of one intercalary
acentric chromosomal segment resulting in one chromosome appearing
shorter and a pair of minutes or acentric rings.
Ring (C/C) - Ring
shaped chromosomes resulting from an exchange between two breaks
occurring on either side of the centromere of the same chromosome.
Dicen = Dicentric (C/C)
- Asymmetrical interchange aberrations due to a breakage in each of two
or more chromosomes followed by aberrant rejoining such that the
proximal regions of the chromosomes become united, thus forming
dicentric structure and an associated acentric fragment(s).
A study was conducted to evaluate the potential of the test material to
induce structural chromosomal aberrations in the haemopoietic cells of
rat bone marrow when administered by oral gavage. Though the study was
carried out before the introduction of the standardised OECD guideline
475, the assay followed the same scientific principles.
The dose levels were based on the results of a preliminary toxicity
test. The maximum tolerated dose was estimated to be 1400 mg/kg, and was
used as the high dose in the definitive study. An additional dose level
of 700 mg/kg was also evaluated as one-half of the maximum tolerated
dose, and was used as the low dose level. The test material and the
vehicle control (corn oil) were administered in single oral doses to
three groups of two male and three female Fisher 344 rats per dose. Animals
were sacrificed at 6, 18 and 30 hours after dosing. An extra group of
rats was dosed with the positive control (Cyclophosphamide 20 mg/kg) and
sacrificed 18 hours later. Approximately two hours prior to each
sacrifice, animals were administered colchicine at 4 mg/kg of body
weight to arrest cells in metaphase. At the appropriate time, animals
were sacrificed and both femurs were removed from each animal and
metaphase slides prepared. Slides were stained, coded and scored for
All rats dosed at 700 mg/kg and 1400 mg/kg exhibited mild to severe
pharmacotoxic signs at all sacrifice time intervals evaluated. These
observations suggest that the test material was tested near the maximum
Statistical analysis of the data indicated that the test material did
not produce statistically significant increases in the number of
aberrations or in the number of aberrant metaphases at any of the three
sacrifice times evaluated.
Therefore the test material was judged negative in its ability to induce
structural chromosomal aberrations to the haemopoietic cells of the rat
bone marrow under the experimental conditions of this assay.
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