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EC number: 200-879-2 | CAS number: 75-56-9
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP near-guideline study performed according to scientific standards, published in peer reviewed literature, acceptable for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Responses of the L5178Y mouse lymphoma forward mutation assay: V. Gases and vapours.
- Author:
- McGregor D, Brown AG, Cattanach P, Edwards I, McBride D, Riach C, Shepherd W, Caspary WJ
- Year:
- 1 991
- Bibliographic source:
- Environ. Molec. Mutagen., 17:122-129
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- no
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Methyloxirane
- EC Number:
- 200-879-2
- EC Name:
- Methyloxirane
- Cas Number:
- 75-56-9
- Molecular formula:
- C3H6O
- IUPAC Name:
- 2-methyloxirane
- Details on test material:
- 1,2 propylene oxide (volatile liquid),
supplied by the National Toxicolgy Programm Chemical Repository, Radian Corporation Austin, TX.
Constituent 1
Method
- Target gene:
- Thymidine Kinase locus
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 (rat liver)
- Test concentrations with justification for top dose:
- 0.04% up to 1.25%
0.63 %-30% - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used:none
Controlsopen allclose all
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without S9
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without S9
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 3-methylcholanthrene
- Remarks:
- with S9
- Evaluation criteria:
- Mutation factor was calculated as: MF= 200 x mutant clones per plate (usually as a mean of 3) divided by total clones per plate (usually mean of 3)=
mutants/10E6 clonable cells. - Statistics:
- Based upon the mathematical model proposed for this system (Lee and Caspary, 1983) and consited of a dose trend test (Barlow, 1972) and a
variance analysis of pairwise comparison of each dose against the vehicle control.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
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