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EC number: 222-746-8 | CAS number: 3598-16-1
A Chromosome Aberration Assay in V79 cells was performed. The test item was dissolved in Dulbecco’s Modified Eagle’s medium and the following concentrations were selected on the basis of cytotoxicity investigations made in a preliminary study. In two independent experiments (both run in duplicate with concurrent negative and positive controls) at least 300 (150-150) well-spread metaphase cells were analysed at concentrations and treatment (exposure)/sampling (expression) intervals given below:
Experiment A with 3/20 h treatment/sampling time without and with S9 mix: 500, 1000 and 2000 μg/mL test item
Experiment B with 20/20 h treatment/sampling time without S9 mix: 500, 1000 and 2000 μg/mL test item
Experiment B with 20/28 h treatment/sampling time without S9 mix: 500, 1000 and 2000 μg/mL test item
Experiment B with 3/28 h treatment/sampling time with S9 mix: 500, 1000 and 2000 μg/mL test item
In both experiments, no statistically significant differences between treatment and concurrent solvent control groups and no dose-response relationships were noted. The observed chromosome aberration were inside the distribution of the laboratory historical negative control data.
There were no biologically relevant increases in the rate of polyploid or endoreduplicated metaphases in either experiment in the presence or absence of metabolic activation.
There was no precipitation of the test item at any dose level tested. No biologically relevant changes in pH or osmolality of the test system were noted at the different dose levels tested.
The number of aberrations found in the solvent controls was compatible with the laboratory historical laboratory control data. The concurrent positive controls ethyl methanesulphonate (0.4 and 1.0 μL/mL) and Cyclophosphamide (5 μg/mL) caused the expected biologically relevant increases of cells with structural chromosome aberrations as compared to solvent controls and were compatible with the historical positive control data. Thus, the study is considered valid.
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