Registration Dossier

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:
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
Name:
Unnamed
Type:
Constituent
Test material form:
other: gas

Method

Species / strain
Species / strain / cell type:
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:
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.