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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
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 resultsopen allclose all
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
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.

Applicant's summary and conclusion