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EC number: 260-828-5
CAS number: 57583-34-3
test material was evaluated for chromosomal aberrations in human
lymphocytes according to OECD guideline 473 and in compliance with GLP.
test material was found miscible in dimethyl sulphoxide at 200 µL/mL. A
precipitation test was conducted at 0.0312, 0.0625, 0.125, 0.25, 0.5, 1
and 2 µL/mL. Post
24 hours of incubation, no precipitation was observed in any
concentrations tested up to 2 µL/mL. No change in pH was observed in any
of the concentration tested. Hence, 2 µL/mL was selected as the highest
concentration for testing in the initial cytotoxicity test. The
other concentrations selected were 0.25, 0.5, 1 and 2 µL/mL of test
an initial cytotoxicity test, cytotoxicity was observed at all tested
a follow-up cytotoxicity test was performed at 0.0078, 0.0156, 0.0312,
0.0625, 0.125 and 0.25 µL/mL to assess the cytotoxicity and to select
the appropriate test concentration for Chromosomal Aberration Test.
a follow-up cytotoxicity test, the cultures were treated with the
test material at
the concentrations of 0.0078, 0.0156, 0.0312, 0.0625, 0.125 and 0.25
µL/mL for short and long term treatment. The
percentage reduction in Mitotic Index was in the range of 10.17 to 77.45
at 0.25, 0.125, 0.0625, 0.0312, 0.0156 and 0.0078 µL/mL. As
the percentage reduction in MI was not more than 45 ± 5 % at 0.125
µL/mL, this was selected as the highest concentration for the
chromosomal aberration test. Other
concentrations selected were 0.0625 and 0.0312 µL/mL.
the chromosomal aberration test, the cells were treated with the
test material at
the concentrations of 0.0039, 0.0078 and 0.0156 µL /mL using DMSO as the
treatment was carried out in duplicates for the short term period (3 to
6 hours) both in the presence and absence of metabolic activation and
for the long term period (20 to 24 hours) in the absence of metabolic
Monohydrate (+S9 for short term) at the concentration of 10 µg/mL and
Mytomycin-C at the concentration of 0.05 µg/mL (-S9 both for short term
and long term) were used as positive controls.
treated cells were harvested at about 1.5 normal cell cycle length after
harvesting of cultures, the cells
were treated with a metaphase-arresting substance (colchicine),
harvested, stained and metaphase cells were analysed microscopically for
the structural chromosomal aberrations.
was no statistically significant increase in the number of aberrant
cells in test material treated cultures when compared with vehicle
control and there
was no concentration-related increase when evaluated with an appropriate
trend test. The reduction
in MI observed at 0.125
µL/mL was 38.19 % in the presence of metabolic
activation and 40.92 % in the absence of metabolic activation for short
term treatments. Similarly, the reduction in MI observed at 0.125
µL/mL was 40.03 % in the absence of metabolic activation system for
long term treatment.
observed mean percent aberrant cells at 0.125, 0.0625 and 0.0312 µL/mL
in the presence of metabolic activation (short term treatment 3 to 6
hours) were 1.0, 1.33 and 1.33 respectively, and fell within the 95 %
confidence level of the laboratory’s historical control data. Similarly,
the observed mean percent aberrated cells at 0.125, 0.0625 and 0.0312
µL/mL in the absence of metabolic activation (short term treatment 3 to
6 hours) were 1.33, 1.00 and 1.67 respectively, and fell within the 95 %
confidence level of the laboratory’s historical control data.
observed mean percent aberrated cells at 0.125, 0.0625 and 0.0312 µL/mL
in the absence of metabolic activation, long term (20 to 24 hours) were
1.33, 1.33 and 1.00 respectively, and fell within the 95 % confidence
level of the laboratory’s historical control data.
concurrent vehicle control values were
within the 95 % control limits of the distribution of the laboratory’s
historical vehicle control database. The
cultures treated with positive controls for the short-term
to 6 hours) both in the presence and absence of metabolic activation,
and for the long-term period (20 to 24 hours) in the absence of
metabolic activation induced were 12.70 %, 11.34 % and 9.67 % of
aberrant cells respectively, which was statistically significant
compared with the respective vehicle control. This
demonstrated sensitivity of the test system towards positive controls
and confirmed that the test conditions were adequate.
the conditions of the study, the
test material is considered
as non-clastogenic up to the concentration of 0.0125 µL /mL both in the
presence and absence of metabolic activation.
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