Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Study period:
not reported
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
unsuitable test system

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Mutation to streptomycin resistance in Klebsiella pneumonia
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2,3,3-tetrafluoropropan-1-ol
EC Number:
200-955-5
EC Name:
2,2,3,3-tetrafluoropropan-1-ol
Cas Number:
76-37-9
Molecular formula:
C3H4F4O
IUPAC Name:
2,2,3,3-tetrafluoropropan-1-ol
Test material form:
not specified

Method

Target gene:
Streptomycin resistance
Species / strain
Species / strain / cell type:
other: Klebsiella pneumoniae
Additional strain / cell type characteristics:
other: uracil and proline auxotroph
Metabolic activation:
not specified
Test concentrations with justification for top dose:
not reported
Vehicle / solvent:
not reported
Details on test system and experimental conditions:
no details reported
Rationale for test conditions:
not reported
Evaluation criteria:
not reported
Statistics:
not reported

Results and discussion

Test results
Key result
Species / strain:
other: Klebsiella pneumoniae
Metabolic activation:
not specified
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
not determinable because of methodological limitations

Applicant's summary and conclusion

Conclusions:
The reported information is insufficient to conclude on mutagenicity in bacterial systems.