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EC number: 203-678-8
CAS number: 109-53-5
in vitro studies no mutagenic activity was found in bacteria or
mammalian cells as well as no clastogenic or aneugenic activity in
Gene mutation in bacteria:
A study was performed to investigate the
potential of Isobutylvinylether to induce gene mutations according to
the plate incorporation test and the pre-incubation test using the
Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the
Escherichia coli strain WP2 uvrA (BASF SE, 2018). The assay was
performed in two independent experiments both with and without liver
microsomal activation. Each concentration, including the controls, was
tested in triplicate. The test item was tested at the following
concentrations: Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000;
2500; and 5000 μg/plate and experiment II: 33; 100; 333; 1000; 2500; and
5000 μg/plate. No precipitation of the test item occurred up to the
highest investigated dose. In experiment I the plates incubated with the
test item showed normal background growth up to 5000 μg/plate with and
without S9 mix in all strains used. In experiment II reduced background
growth was observed in all strains with and without S9 mix, except of
strain WP2 uvrA. Toxic effects, evident as a reduction in the number of
revertants (below the indication factor of 0.5), were observed in
experiment I in strain TA 100 with S9 mix from 2500 to 5000 μg/plate and
in experiment II in strain TA 100 from 1000 to 5000 μg/plate without S9
mix and at 1000 and 5000 μg/plate with S9 mix. No substantial increase
in revertant colony numbers of any of the five tester strains was
observed following treatment with Isobutylvinylether at any dose level,
neither in the presence nor absence of metabolic activation (S9 mix).
There was also no tendency of higher mutation rates with increasing
concentrations in the range below the generally acknowledged border of
biological relevance. Appropriate reference mutagens, used as positive
controls, induced a distinct increase in revertant colonies and thus,
showed the sensitivity of the test system and the activity of the
metabolic activation system. In conclusion, the test item did not induce
gene mutations by base pair changes or frameshifts in the genome of the
strains used. Therefore, Isobutylvinylether is considered to be
non-mutagenic in this Salmonella typhimurium and Escherichia coli
reverse mutation assay.
In a supporting study comparable to OECD
TG471 with acceptable restrictions (non-GLP; only 4 strains tested; E.
coli WP2 or S. typhimurium TA102 strain missing, however, no oxidizing
or cross linking activity expected) S. typhimurium TA98, TA100, TA1535,
or TA1537 were exposed to 0, 20, 100, 500, 2500, 5000 µg/plate with and
without S9 -mix in 1) the standard plate test and 2) in the
preincubation test (triplicate plates; vehicle control, pos. control).
No increase in the number of revertants was found at dose levels
including the recommended limit dose of 5 mg/plate. A bacteriotoxic
effect was seen only in the preincubation test with S9-mix from 500 or
2500 µg/plate onward (all tester strains) and without S9-mix at a dose
of 5000 µg/plate (only in TA1535). Positive control substances caused
increases in the number of revertants as expected, indicating proper
test conditions. Data on historical controls were not available,
however, vehicle controls were within the range of literature values.
Conclusion: No mutagenicity was seen in S.
typhimurium TA98, TA100, TA1535, TA1537 in the presence and absence of
metabolic activation at dose levels up to the recommended limit dose (5
Gene mutation in mammalian cells:
assessed for its potential to induce gene mutations at the
hypoxanthine-guaninephosphoribosyltransferase (HPRT) locus in Chinese
hamster ovary (CHO) cells in vitro (BASF SE, 2018). In this study, in
the absence and the presence of metabolic activation no relevant
cytotoxicity (relative survival below 20%) was observed up to the
highest evaluated concentration (800 µg/mL; lowest precipitating
concentration) evaluated for gene mutations. The vehicle controls gave
mutant frequencies within the range expected for the CHO cell line. Both
positive control substances led to the expected statistically
significant increase in the frequencies of forward mutations. The test
substance did not cause any biologically relevant increase in the mutant
frequencies either without S9 mix or after the addition of a
metabolizing system. Thus, Isobutylvinylether is not mutagenic in the
HPRT locus assay under in vitro conditions in CHO cells in the absence
and the presence of metabolic activation.
In a further HPRT assay (BASF 1993, GLP
Guideline study according to OECD TG476), Chinese hamster Ovary (CHO)
cells were exposed with and without metabolic activation (MA) to 0,
0.01; 0.05; 0.10; 0.50; 1; 5; 10 mg/mL in 2 independent experiments.
Negative control, vehicle (DMSO) control and positive control were
valid. Cytotoxic effects (reduced cloning efficiencies) were seen at >=
5 mg/mL with and without MA. No mutagenicity was reported in the 1st
experiment. In the 2nd trial, statistically significant increases in
mutant frequencies were detcted without MA at 0.50 mg/mL and with MA at
0.01, 0.05 and 5 .0 mg/mL; the increases were not considered to be
biologically significant because none of the other criteria for a
positive response were met and because the statistical significances
were mainly due to the unusually low, but within the historical range
lying mutation rates of the respective controls.
In a mammalian cell chromosome aberration
assay (according to OECD TG473) V79 cells were treated with 0, 1250,
2500, 5000 µg/mL in the presence and absence of a metabolic activation
system (MA). The exposure period was 4 h with MA and 18 without MA.
Samples were harvested at 18 h (low, intermediate and top dose) and 28 h
(top dose only) after the beginning of a 4 -hour treatment (with MA) or
of a 18 -hour treatment (without MA). Concurrent negative controls,
vehicle controls and positive controls were valid. No cytotoxic effects
were seen even at the high dose level (recommended limit dose). The test
substance did not lead to an increase of structural chromosomal
aberrations incl. and excl. gaps either with or without MA. The
significant increase in aberration at a sampling time of 28 h is of no
biological relevance; the observed values are within the range of the
historical control data for this sampling time. An increase in the
number of cells containing numerical chromosomal aberrations was not
Conclusion: The test substance showed
neither chromosome damaging (clastogenic) effects nor an aneugenic
activity in V79 cells in vitro.
Short description of key information:
In in vitro studies no mutagenic activity was found in bacteria or
mammalian cells as well as no clastogenic or aneugenic activity in
Endpoint Conclusion: No adverse effect observed (negative)
is not warranted
according to the criteria of EU Classification, Labelling and Packaging
of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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