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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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 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:
1995

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

Constituent 1
Chemical structure
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

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.