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- other: unpublished data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- HFP: DuPont Co., Unpublished data, hexafluoropropylene mutation - Ames test, 1980
- HFA: DuPont Co., Unpublished data, in vitro microbial mutagenicity studies (Ames test) of hexafluoroacetone sesquihydrate, 1975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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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