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EC number: 253-959-4
CAS number: 38465-60-0
In a GLP-compliant micronucleus test,
performed according to OECD Guideline 487, potassium tetrafluoroborate
was examined for its potential to induce micronuclei in cultured
binucleated human lymphocytes, in both the absence and presence of a
metabolic activation system (S9 -mix). Two independent in vitro
micronucleus tests were conducted for which blood was obtained from two
different donors. Dimethylsulfoxide (DMSO) was used as solvent for the
test substance. Dose levels ranging from 2.5 to 1260 μg/mL were tested
as final concentrations in the culture medium. Cytotoxicity was
calculated from the Cytokinesis-Block Proliferation Index (CBPI). In the
first test, in the presence and absence of metabolic activation (S9-mix)
the treatment/recovery time was 4/20 hours (pulse treatment). In the
second test, in the absence of metabolic activation, the
treatment/recovery time was 20/28 hours (continuous treatment group). In
the first test, in the presence of metabolic activation, a trend towards
slightly decreased CBPI-values was observed at all dose levels. In the
absence of metabolic activation, no cytotoxicity was observed. In the
pulse treatment test, analysis of micronuclei formation was carried out
at three dose levels (1260, 630 and 315 μg/mL), in the cultures of the
solvent control and in the cultures of the positive controls. In the
second test, no cytotoxicity was observed at any of the dose levels
analysed. In the continuous treatment group, analysis of micronuclei
formation was carried out in the cultures of three dose levels (1260,
1000 and 800 μg/mL) of the test substance, the cultures of the solvent
control and the cultures of the positive controls. In both the first and
the second test, the negative controls were within the historical data.
Treatment with the positive controls, cyclophosphamide, vinblastine
sulphate and mitomycin C, resulted in statistically significant
increases in the numbers of binucleated cells containing micronuclei,
when compared to the numbers observed in the cultures treated with the
solvent control. This demonstrates the validity of the study. In both
the first and second test, the test substance did not cause a
significant increase in the number of binucleated cells containing
micronuclei, at any of the dose levels analysed, when compared to the
numbers found in the concurrent negative control. From the results
obtained in the first and second in vitro micronucleus test it is
concluded that, under the conditions used in this study, the test
substance potassium tetrafluoroborate was not clastogenic and/or
aneugenic to cultured human lymphocytes.
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