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EC number: 204-310-9 | CAS number: 119-27-7
A Chromosome aberration test in Human Lymphocytes in vitro, Bowles A., 2018, has been performed according to the 473 OECD guideline.
Duplicate culture of human lymphocytes, treated with the test item were evaluated for chormosome aberrations at 3 dose levels, together with vehicle and positive controls, at 3 exposure conditions : 4 hours exposure in the presence of an induce rat liver homogenate metabolizing system (S9), 4 hours expposure in the absence of metabolic activation (S9) both 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 should be limited on both precipitate and toxicity, depending on the exposure group (0, 40, 80, 160, 320, 560, 640, 960 µg/mL : concentrations tested for the 4 -hour exposure either with and without S9 and 0, 10, 20, 40, 60, 80 120, 240 µg/mL: concentrations used for the 24 -hour exposure without S9).
All vehicle 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 toxic to human lymphocytes but did not induce any statistically significant increases in the frequency of cells with aberration either in the presence or absence of metabolic activation at any dose level in any of the exposure groups.
The test item, DNAN was considered to be non-clastogenic to human lymphocytes in vitro.
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