Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Published in 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1990

Materials and methods

Principles of method if other than guideline:
No details provided (literature review on different substances)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
gas
Specific details on test material used for the study:
The data on two fluorine-containing monomers structurally close to HFIB (C4H2F6) are used:
- Hexafluoropropylene (HFP) = C3F6 - CAS 116-15-4
- Hexafluoroacetone (HFA) = C3F6O - CAS 684-16-2

Method

Species / strain
Species / strain:
other: strain not specified
Test concentrations with justification for top dose:
Not specified
Vehicle:
Not specified
Details on test system and conditions:
Not specified
Rationale for test conditions:
Not specified
Evaluation criteria:
Not specified
Statistics:
Not specified

Results and discussion

Test results
Species / strain:
other: unspecified strain
Metabolic activation:
not specified
Genotoxicity:
not specified
Cytotoxicity:
not specified
Remarks on result:
other: unpublished data
Additional information on results:
Ames test were negative for both HFP and HFA.

Any other information on results incl. tables

Primary data sources cited as references:

- HFP: DuPont Co., Unpublished data, hexafluoropropylene mutation - Ames test, 1980

- HFA: DuPont Co., Unpublished data, in vitro microbial mutagenicity studies (Ames test) of hexafluoroacetone sesquihydrate, 1975

Applicant's summary and conclusion

Conclusions:
Based on negative Ames tests on two fluorine-containing monomers structurally close to HFIB (C4H2F6): Hexafluoropropylene (HFP, C3F6 - CAS 116-15-4) and Hexafluoroacetone (HFA, C3F6O - CAS 684-16-2), it can be considered that HFIB is not susceptible to show mutagenic activity in bacterial systems.