2,2-dimethyloxirane

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

Study period:

1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented report which meets basic scientific principles.

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)

Version / remarks:

Ames test without TA102 and Escherichia coli, adopted 1983-05-26

Principles of method if other than guideline:

Method: other: Ames, B.N., McCann, J. and Yamasaki, E. (1975) Mut. Res., 31, 347-364.

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2,2-dimethyloxirane

EC Number:

209-193-8

EC Name:

2,2-dimethyloxirane

Cas Number:

558-30-5

Molecular formula:

C4H8O

IUPAC Name:

2,2-dimethyloxirane

Details on test material:

Please refer to the section "confidential details on test material" below.

Method

Species / strain

Species / strain / cell type:

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

Additional strain / cell type characteristics:

other: deep rough character (rfa), UV sensitivity (uvrB), ampicillin resistance (R factor plasmid)

Metabolic activation:

with and without

Metabolic activation system:

S9 mix (from liver homogenate of Aroclor 1254)

Test concentrations with justification for top dose:

0, 20, 100, 500, 2500 and 5000 µg/plate: all strains;
0, 2000, 3000, 4000, 5000 and 6000 µg/plate: TA1535

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: complete solubility of the test substance in DMSO

Controls

Untreated negative controls:

yes

Remarks:

, sterility control for each tester strain

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: with S9 mix: 2-aminoanthracene for all strains; without S9 mix: N-methyl-N'-nitro-N-nitroso-guanidine for the strains TA 100 and TA 1535, 4-nitro-o-phenylenediamine for the strain TA 98, 9-aminoacridine chloride monohydrate for the strain TA 1537

Remarks:

control substances: dissolved in DMSO

Details on test system and experimental conditions:

IUCLID4 Type: Ames test

Evaluation criteria:

A substance was regarded as positive depending on following requirements
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results

Statistics:

Not indicated

Results and discussion

Test results

Test results 1

Species / strain:

other: Salmonella typhimurium strains TA100, TA1537, TA98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: A bacteriotoxic effect was observed only using TA 1537 without S-9 mix at 2500 µg and 5000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

no 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'.

Any other information on results incl. tables

TA1535: With S-9 mix slightly enhanced figures at 6000 µg/plate (factor 1.9). Without S-9 mix weakly positive reaction from about 2000 µg - 2500 µg/plate onward with a maximum increase in the number of his+ revertants by a factor of 2.6 at 5000 µg/plate.

The test substance was weakly mutagenic.