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EC number: 609-530-2
CAS number: 38172-91-7
The Ames Test was carried out in
accordance with the OECD guideline for testing of chemicals "Genetic
Toxicology: Salmonella typhimurium, Reverse Mutation Assay", No. 471 and
in accordance with the EEC Directive 92/69, B 14: Mutagenicity
(Salmonella typhimurium - reverse mutation assay). The test was
performed as Standard Plate Test and Preincubation Test with and without
a metabolic activation using the indicator organisms TA 1535, TA 1537,
TA 98 and TA 100. Parallel with each experiment a negative control
(vehicle control, sterility control) was carried out for each tester
strain in order to determine the spontaneous mutation rate. Furthermore
positive control substances were used to check the mutability of the
bacteria and the activity of the S-9 mix: 2 -aminoanthracene (with S-9
mix, for the strains TA 100, TA 98, TA 1537 and TA 1535),
N-methyl-N'-nitro-N-nitrosoguanidine ( without S-9 mix, for the strains
TA 100 and TA 1535), 4 -nitro-o-phenylendiamine (without S-9 mix, for
the strain TA 98), 9 -aminoacridine chloride monohydrate (without S-9
mix, for the strain TA 1537). Each experiment was performed with 3 test
plates per dose or control while the concentrations of the test item
were 20, 100, 500, 2500, and 5000 µg/plate. Neither the preincubation
test nor the standard plate test with or without metabolic activation
increased the number of his+ revertants in any of the tested bacteria
The study was performed to investigate
the potential of 2-Propyn-1-ol, compd. with methyloxirane to induce gene
mutations at the HPRT locus in V79 cells of the Chinese hamster. The
study was performed according to OECD 476 guideline and GLP (BASF SE,
The assay was performed in two
independent experiments, using two parallel cultures each. The first
main experiment was performed with and without liver microsomal
activation and a treatment period of 4 hours. The second experiment was
performed with a treatment time of 4 hours with and 24 hours without
The highest concentration applied in
the pre-experiment was 7690 μg/mL according to OECD guideline,
considering the purity of the test item (preliminary information
concerning the purity at the start of the experiment: 65 - 69% main
component; 31 - 35% water). The concentration range of the main
experiments was limited by cytotoxic effects. The test item was
dissolved in deionised water.
No substantial and reproducible dose
dependent increase of the mutation frequency was observed up to the
maximum concentration with and without metabolic activation.
Appropriate reference mutagens (EMS
and DMBA), used as positive controls, induced a distinct increase in
mutant colonies and thus, showed the sensitivity of the test system and
the activity of the metabolic activation system.
In conclusion it can be stated that
under the experimental conditions reported the test item did not induce
gene mutations at the HPRT locus in V79 cells. Therefore, 2-Propyn-1-ol,
compd. with methyloxirane is considered to be non-mutagenic in this HPRT
Chromosome Aberration test
The test item 2-Propyn-1-ol, compd.
with methyloxirane, dissolved in deionised water, was assessed for its
potential to induce structural chromosome aberrations in V79 cells of
the Chinese hamster in vitro in two independent experiments according to
OECD 473 guideline and GLP (BASF SE, 2012).
ln each experimental group two
parallel cultures were set up. At least 100 metaphases per culture were
evaluated for structural chromosome aberrations, except for the positive
control in Experiment IB without metabolic activation, where only 50
metaphases were evaluated.
The highest applied concentration
(7690.0 ug/ml) was chosen with regard to the composition of the test
item and with respect to the current OECD Guideline 473 (preliminary
information concerning the purity at the start of the experiment: 65 -
69%> main component; 31 - 35% water).
Dose selection for the cytogenetic
experiments was performed considering the toxicity data.
ln Experiment lA in the absence and
presence of S9 mix clear cytotoxicity was observed at the highest
evaluated concentration. ln Experiment IB only moderate cytotoxicity was
observed in the absence and presence of S9 mix.
Statistically significant increases of
aberrant cells were observed in Experiment lA in the absence of S9 mix
after treatment with 3845.0 ug/ml (4.8 % aberrant cells, excluding gaps)
and in the presence of S9 mix after treatment with 961.3 ug/ml (5.3 %
aberrant cells, excluding gaps). Both values exceeded the range of the
historical solvent control data (0.0 - 4.0 °/o aberrant cells, excluding
gaps). ln Experiment IB clastogenicity clearly exceeding the historical
solvent control data (0.0- 4.0 % aberrant cells, excluding gaps) was
observed at nearly all evaluated concentrations with (8.5 - 14.5 %
aberrant cells, excluding gaps) and without (7.0 - 16.0 % aberrant
cells, excluding gaps) metabolic activation. However, the
value at 721.0 ug/ml in the presence
of S9 mix (5.0 % aberrant cells, excluding gaps) is slightly exceeding
the historical solvent control data but is not statistically
significant. The percentage of aberrant cells, excluding gaps after
treatment with 3364.4 ug/ml in the absence of S9 mix is statistically
significant (3.0 %) due to the low response in the solvent control (0.5
% aberrant cells, excluding gaps). Additionally, the number of cells,
carrying exchanges was markedly increased in both experimental parts.
No relevant increase in polyploid and
endomitotic metaphases was found after treatment with the test item as
compared to the frequencies of the control cultures.
Appropriate mutagens (EMS and CPA)
were used as positive controls. They induced statistically significant
increases in cells with structural chromosome aberrations.
ln conclusion, it can be stated that
under the experimental conditions reported, the test item induced
structural chromosome aberrations in V79 cells (Chinese hamster
cellline) in vitro.
Therefore, 2-Propyn-1-ol, compd. with
methyloxirane is considered to be clastogenic in this chromosome
aberration test in the absence and presence of metabolic activation,
when tested up to cytotoxic or the highest required concentrations.
This study was performed to
investigate the potential of 2-Propyn-1-ol, compd. with methyloxirane to
induce micronuclei in polychromatic erythrocytes (PCE) in the bone
marrow of the mouse according to OECD 474 guideline and GLP (Harlan CCR,
The test item was dissolved in sterile
water, which was also used as vehicle control. The volume administered
orally was 10 mL/kg b.w.. 24 h and 48 h after a single administration of
the test item the bone marrow cells were collected for micronuclei
At least five males per test group
were evaluated for the occurrence of micronuclei. Per animal 2000
polychromatic erythrocytes (PCEs) were scored for micronuclei.
To investigate a cytotoxic effect due
to the treatment with the test item the ratio between polychromatic and
normochromatic erythrocytes was determined in the same sample and
reported as the number of PCEs per 2000 erythrocytes.
Based on results of pre-experiments,
doses of 250, 500 and 1000 mg/kg b.w. for male mice administered once
orally were selected for the main experiment. However, due to high
mortality observed at 1000 mg/kg (4 of 7 males of the 48 hours group)
this dose was not appropriate for evaluation in accordance with the
guidelines (less than 5 animals available for evaluation in the 48 hour
group and maximum tolerated dose level clearly exceeded). Additional
groups of male mice were treated including vehicle and positive control
in a second main experiment in order to fulfil the OECD guideline
requirements for a valid study. Finally, following dose levels of the
test item were investigated and evaluated :
24 h preparation interval: 125b),
250a), and 500a)mg/kg b.w.
48 h preparation interval: 500b)mg/kg b.w.
main experimentb)Second main experiment
In the second main experiment one of 7
males died after treatment with the high dose (500 mg/kg b.w., 48 hours
After treatment with the test item the
number of PCEs was not substantially decreased as compared to the mean
value of PCEs of the vehicle control thus indicating that 2-Propyn-1-ol,
compd. with methyloxirane did not exert a cytotoxic effect in the bone
In comparison to the corresponding
vehicle controls there was no biologically relevant or statistically
significant enhancement in the frequency of the detected micronuclei at
any preparation interval after administration of the test item and with
any dose level used. Only the micronucleus frequency found in the high
dose group (48 hours treatment) was statistically significantly higher
(0.108%) compared to the concurrent vehicle control value, which was
incidentally quite low (0.030%). However, the micronucleus frequency in
the 500 mg/kg (48h) group as well as in all other test item treated dose
groups at any preparation interval were very well within the
laboratory’s historical vehicle control data (0.010-0.250%, mean
0.108%). Thus, the observed statistical significance at 500 mg/kg (48h)
was not considered to have any biological relevance.
40 mg/kg b.w. cyclophosphamide
administered orally was used as positive control which showed a
substantial increase of induced micronucleus frequency.
In conclusion, it can be stated that
under the experimental conditions reported, the test item 2-Propyn-1-ol,
compd. with methyloxirane did not induce micronuclei as determined
by the micronucleus test with bone marrow cells of the mouse.
Therefore, 2-Propyn-1-ol, compd. with
methyloxirane is considered to be non-mutagenic in this micronucleus
Short description of key information:
Ames-Test (BASF AG, 1995): negative
HPRT-Test (BASF SE, 2012): negative
Mikronucleus-Assay (Harlan CCR, 2013): negative
Endpoint Conclusion: No adverse effect observed (negative)
Negative results were obtained with an Ames-Test and with a HPRT-Test.
The positive in vitro results in a chromosome aberration test could not
be confirmed in an in vivo Micronucleus Assay. Threfore no
classification for mutagenicity is required according to EU directive
67/548/EEC and EU classification, Labelling and Packaging of Substances
and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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