Registration Dossier
Registration Dossier
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EC number: 206-840-6 | CAS number: 382-10-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Based on negative Ames tests on two fluorine-containing monomers structurally close to HFIB, it can be considered that HFIB is not susceptible to show mutagenic activity in bacterial systems.
Link to relevant study records
- 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
- 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
- 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 - Species / strain / cell type:
- S. typhimurium, other: strain not specified
- Test concentrations with justification for top dose:
- Not specified
- Vehicle / solvent:
- Not specified
- Details on test system and experimental conditions:
- Not specified
- Rationale for test conditions:
- Not specified
- Evaluation criteria:
- Not specified
- Statistics:
- Not specified
- Species / strain:
- S. typhimurium, other: unspecified strain
- Metabolic activation:
- not specified
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- not specified
- Additional information on results:
- Ames test were negative for both HFP and HFA.
- Remarks on result:
- other: unpublished data
- 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.
Reference
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- HFP: DuPont Co., Unpublished data, hexafluoropropylene mutation - Ames test, 1980
- HFA: DuPont Co., Unpublished data, in vitro microbial mutagenicity studies (Ames test) of hexafluoroacetone sesquihydrate, 1975
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the limited information available showing absence of mutagenic effects in vitro, no classification for genetic toxicity is warranted.
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