2-Propyn-1-ol, reaction product with 1-2.5 moles of oxirane

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP, OECD guideline study, Source substance for RA information according to analogue justification.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of 2-Propyn-1-ol with methyloxirane

EC Number:

609-530-2

Cas Number:

38172-91-7

IUPAC Name:

Reaction product of 2-Propyn-1-ol with methyloxirane

Details on test material:

- Physical state: liquid
- Analytical purity: 53.4 %
- Impurities (identity and concentrations): 33 % water, 55 ppm Propylene oxide, others: Propylene glycol, Propargyl alcohol,
- Stability under test conditions: proven by reanalysis
- Stability in of test substance in aqua dest. (vehicle) was verified analytically
- Storage condition of test material: Room temperature (protected from light, N2 conditions)

Method

Target gene:

HIS

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S-9 mix

Test concentrations with justification for top dose:

20; 100; 500; 2500 and 5000 µg/plate

Vehicle / solvent:

purified water

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: see: Any other information on materials and methods

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation); preincubation

DURATION
- Preincubation period: 20 min
- Exposure duration: 48 hours

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate ( control)
- dose-response relationship
- reproducibility of the results.

Statistics:

not applicable

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS

- Precipitation: no precipitates found


ADDITIONAL INFORMATION ON CYTOTOXICITY: No bacteriotoxic effect (reduced his' background growth, decrease in the number of his+ revertants) was observed.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Neither the the preincubation test nor the standard plate test with or without S-9 mix increased the number of his+ revertants in any of the tested bacteria strains.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Executive summary:

The substance 2-Propyn-1-ol, compd. with methyloxirane was tested for its mutagenic potential based on the ability to induce back mutations in selected loci in several strains of Salmonella typhimurium ( TA 1535, TA 100, TA 1537, TA 98) in the Ames test with a concentration range of 20 µg - 5000 µg/plate with and without metabolic activation according to OECD 471 under GLP conditions.

Toxicity: No bacteriotoxic effect was observed.

Mutagenicity: An increase in the number of his+ revertants was not observed both in the standard plate test and in the preincubation test either without S-9 mix or after the

addition of a metabolizing system.

According to the results of the present study, the test substance 2-Propyn-1-ol, compd. with methyloxirane is not mutagenic in the Ames test under the experimental conditions chosen here.(BASF 1995)