Propyloxirane

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well-documented report, comparable to guideline/standards

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1,2-epoxybutane

EC Number:

203-438-2

EC Name:

1,2-epoxybutane

Cas Number:

106-88-7

Molecular formula:

C4H8O

IUPAC Name:

2-ethyloxirane

Details on test material:

purity: 99.9 %

Method

Target gene:

bacterial strains

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

rat liver S-9 mix

Test concentrations with justification for top dose:

20 ug - 5000 ug/plate (all tester strains)
20 ug - 7500 ug/plate (TA 100)

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene with S-9 mix, N-methyl-N'-nitro-Nnitroso- guanidine, 4-nitro-o-phenylenediamine and 9-aminoacridine chloride monohydrate without S-9 mix

Details on test system and experimental conditions:

Bacterial test strains were used in the presence and absence of S-9 mix. Three test plates per dose or per control were run in each of the two experiments.

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:

none

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Toxicity: No bacteriotoxic effect was observed.
Mutagenicity: TA 1535 and TA 100: A weakly positive reaction was observed with and without S-9 mix depending in the strain and test conditions at doses 2 2500 ug/plate (factor 1.7 - 3.4). TA 1535 and TA 98: No increase in the number of his+ revertants.

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):
positive

According to the results of the present study, the test substance n-Butylenoxid-1,2 is weakly mutagenic in the Ames test under the experimental conditions chosen here.