2-methylbut-3-yn-2-ol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in mammalian cells

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

mammalian cell gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Prop-2-yn-1-ol

EC Number:

203-471-2

EC Name:

Prop-2-yn-1-ol

Cas Number:

107-19-7

Molecular formula:

C3H4O

IUPAC Name:

prop-2-yn-1-ol

Details on test material:

Purity: 99.8%

Method

Target gene:

HPRT-locus

Species / strain

Species / strain / cell type:

Chinese hamster Ovary (CHO)

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9-Mix

Test concentrations with justification for top dose:

1st Experiment
without S9 mix (4-hour exposure period)
0; 6.25; 12.5; 25.0; 50.0; 100.0; 150.0; 200.0 µg/mL
with S9 mix (4-hour exposure period)
0; 1.25; 2.5; 5.0; 10.0; 15.0; 20.0; 30.0 µg/mL
2nd Experiment (requirements of the OECD Guideline 476 were failed)
without S9 mix (24-hour exposure period)
0; 6.25; 12.5; 25.0; 50.0; 100.0; 150.0; 200.0 µg/mL
with S9 mix (4-hour exposure period)
0; 1.25; 2.5; 5.0; 10.0; 15.0; 17.5; 25.0 µg/mL
3rd Experiment
without S9 mix (24-hour exposure period)
0; 12.5; 25.0; 50.0; 100.0; 200.0; 300.0; 400.0 µg/mL
with S9 mix (4-hour exposure period)
0; 0.63; 1.25; 2.5; 5.0; 10.0; 15.0; 17.5; 20.0 µg/mL

Vehicle / solvent:

culture medium (Ham's F12)

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

ethylmethanesulphonate

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

3-methylcholanthrene

Details on test system and experimental conditions:

After an attachment period of 20 - 24 hours and a treatment period of 4 hours both with and without metabolic activation and 24 hours without metabolic activation, an expression phase of about 6 - 8 days and a selection period of about 1 week followed. The colonies of each test group were fixed with methanol, stained with Giemsa and counted.

Statistics:

Due to the clearly negative findings, a statistical evaluation was not carried out.

Results and discussion

Test results

Species / strain:

Chinese hamster Ovary (CHO)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Under the experimental conditions chosen, the conclusion is drawn that Propargyl alcohol highly conc. is not a mutagenic substance in the HPRT locus assay using CHO cells in the absence and the presence of metabolic activation.

Executive summary:

The substance Propargyl alcohol highly conc. was assessed for its potential to induce gene mutations at the hypoxanthine-guanine phosphoribosyl transferase (HPRT) locus in Chinese hamster ovary (CHO) cells in vitro. Three independent experiments were carried out, with and without the addition of liver S9 mix from induced rats (exogenous metabolic activation). The vehicle controls gave mutant frequencies within the range expected for the CHO cell line. Both positive control substances, EMS and MCA, led to the expected increase in the frequencies of forward mutations.

In this study, in the 1st and 3rd Experiment in the absence and presence of metabolic activation the highest concentrations tested for gene mutations were clearly cytotoxic.

On the basis from the results of the present study, the test substance did not cause any relevant increase in the mutant frequencies both either without S9 mix or after adding a metabolizing system in two valid experiments performed independently of each other.

Thus, under the experimental conditions of this study, the test substance Propargyl alcohol highly conc. is not mutagenic in the HPRT locus assay under in vitro conditions in CHO cells in the absence and the presence of metabolic activation.