Registration Dossier
Registration Dossier
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EC number: 206-996-5 | CAS number: 420-46-2
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 478
- Principles of method if other than guideline:
- The study was conducted to satisfy the requirements of pharmaceutical product registration.
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Norflurane
- EC Number:
- 212-377-0
- EC Name:
- Norflurane
- Cas Number:
- 811-97-2
- Molecular formula:
- C2H2F4
- IUPAC Name:
- 1,1,1,2-tetrafluoroethane
- Test material form:
- other: gas
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: Mouse lymphoma L51787
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver homogenate derived from rats pre-treated with Aroclor 1254
- Test concentrations with justification for top dose:
- Concentrations up to 100% v/v of the available head space
- Vehicle / solvent:
- Not applicable
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- other: Not applicable
- Positive controls:
- other: Unidentified gaseous positive controls were used
- Details on test system and experimental conditions:
- Exposure period of 4 hours per day
Results and discussion
Test results
- Species / strain:
- mammalian cell line, other: Mouse lymphoma L51787
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- other: Results not reported
- 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):
negative
-ve with or without metabolic activation - Executive summary:
HFC 134a was not mutagenic to mouse lymphoma L51787 cells with or without metabolic activation.
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