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EC number: 263-503-6
CAS number: 62314-25-4
Duplicate cultures of human lymphocytes, treated with the test item,
were evaluated for chromosome aberratios at three dose levels, together
with vehicle and positive controls. In this study, three exposure
conditions were investigated; 4 hours exposure in the presence of
an induced rat liver homogenate metabolizing system (S9), at a 2% final
concentration with cell harvest after a 20-hour expression period, 4
hours exposure in the absence of metabolic activation (S9) with a
20-hour expression period and a 24-hour exposure in the absence of
metabolic activation. The dose levels used in the Main Experiment were
selected using data from the preliminary toxicity test where the results
indicated that the maximum concentration was the maximum recommended
All vehicle (Eagle's minimal essential medium with HEPES buffer (MEM))
controls had frequencies of cells with aberrations within the range
expected for normal human lymphocytes.
All the positive control items induced statistically significant
increases in the frequency of cells with aberrations. Thus, the
sensitivity of the assay and the efficacy of the S9-mix were validated.
The test item was non-toxic to human lymphocytes and did not induce any
statistically significant increases in the frequency of cells with
aberrations, using a dose range that included a dose level that was the
maximum recommended dose level.
The test item, Hydroxypropyl, 2-, trimethylammonium formate was
considered to be non-clastogenic to human lymphocytes in vitro.
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