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EC number: 219-741-8
CAS number: 2517-43-3
The study evaluated the effect of 3-Methoxybutanol on the number of
chromosome aberrations in cultured peripheral human lymphocytes in the
presence and absence of a metabolic activation system (phenobarbital and
ß-naphthoflavone induced rat liver S9-mix). The possible clastogenicity
of 3-Methoxybutanol was tested in two independent experiments.
The described study procedures were based on the most recent OECD and EC guidelines.
Batch 120000267542 of 3-Methoxybutanol was a clear colourless liquid
with a purity of 99.7%(m). 3-Methoxybutanol was dissolved in RPMI 1640
medium. In the first cytogenetic assay, 3-Methoxybutanol was tested up
to 1042 μg/ml (= 0.01 M) for a
3 h exposure time with a 24 h fixation time in the absence and presence
of 1.8% (v/v) S9-fraction. This is the highest concentration which
should be tested according to the guidelines.
In the second cytogenetic assay, 3-Methoxybutanol was tested up to 1042
μg/ml for a 24 h and 48 h continuous exposure time with a 24 h and
48 h fixation time in the absence of S9-mix. In the presence of S9-mix
3-Methoxybutanol was also tested up to 1042 μg/ml for a 3 h exposure time
with a 48 h fixation time.
The number of cells with chromosome aberrations found in the solvent
control cultures was within the laboratory historical control data
range. Positive control chemicals, mitomycin C and cyclophosphamide,
both produced a statistically significant increase in the incidence of
cells with chromosome aberrations, indicating that the test conditions
were adequate and that the metabolic activation system (S9-mix)
3-Methoxybutanol did not induce a statistically significant or
biologically relevant increase in the number of cells with chromosome
aberrations in the absence and presence of S9-mix, in either of the two
independently repeated experiments.
No effects of 3-Methoxybutanol on the number of polyploid cells and
cells with endoreduplicated chromosomes were observed both in the
absence and presence of S9-mix. Therefore it can be concluded that
3-Methoxybutanol does not disturb mitotic processes and cell cycle
progression and does not induce numerical chromosome aberrations under
the experimental conditions described in this report.
The final conclusion was that the test was valid and that
3-Methoxybutanol is not clastogenic in human lymphocytes under the
described experimental conditions.
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