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EC number: 692-614-6
CAS number: 5660-53-7
revertant colony counts in the definitive study
control: DMSO (100 µL/plate)
with metabolic activation only
study was performed to investigate the potential of the test item, 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol,
to induce reverse mutation inSalmonella typhimurium. The study
was performed according to OECD guideline no. 471 and in compliance with
the Principles of Good Laboratory Practice.
preliminary toxicity test was performed to define the dose-levels of
2-isobutyl-2-methyl-1,3-dioxolane-4-methanol to be used for the
mutagenicity study. The test item was then tested according to the
direct plate incorporation, with and without a metabolic activation
system, the S9 mix, prepared from a liver post-mitochondrial
fraction (S9 fraction) of rats induced with Aroclor 1254.
strains of bacteria Salmonella typhimuriumTA 1535, TA 1537,
TA 98, TA 100 and TA 102 were used. Each strain was exposed to five
dose-levels of the test item (three plates/dose‑level). After 72 hours
of incubation at 37°C, the revertant colonies were scored.
evaluation of the toxicity was performed on the basis of the observation
of the decrease in the number of revertant colonies and/or a thinning of
the bacterial lawn.
test item was dissolved in DMSO.
the test item was non-cytotoxic to strain TA100 in the absence of
metabolic activation in the preliminary test, the highest dose-level
selected for the main experiment was 5000 µg/plate, according to the
criteria specified in the international guidelines. The selected
treatment-levels were 50, 150, 500, 1500 and 5000 µg/plate for the five
strains, in the presence and in the absence of metabolic activation. The
number of revertants for the vehicle and positive controls was as
specified in the acceptance criteria. The study was therefore considered
to be valid.
noteworthy toxicity was noted at any dose-levels in the absence or in
the presence of metabolic activation except with strain TA102 with S9
mix were toxicity was noted at the dose-level of 5000 µg/plate. The test
item did not induce any substantial increase in the number of
revertants, either with or without S9 mix, in any of the five strains.
conclusion, the test item did not show any mutagenic activity in the
bacterial reverse mutation test with Salmonella typhimurium, in
the absence or in the presence of a rat metabolising system therefore 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol
not classified according to Annex VI of the Directive 67/548/CEE and
according to EU Regulation 1272/2008 (CLP).
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