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EC number: 216-703-2 | CAS number: 1644-11-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,1,1,2,3,3-hexafluoro-2-(heptafluoropropoxy)-3-[(trifluorovinyl)oxy]propane
- EC Number:
- 216-703-2
- EC Name:
- 1,1,1,2,3,3-hexafluoro-2-(heptafluoropropoxy)-3-[(trifluorovinyl)oxy]propane
- Cas Number:
- 1644-11-7
- Molecular formula:
- C8F16O2
- IUPAC Name:
- 1,1,1,2,2,3,3-heptafluoro-3-({1,1,1,2,3,3-hexafluoro-3-[(1,2,2-trifluoroethenyl)oxy]propan-2-yl}oxy)propane
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch: 19B2059
- Expiration date of the lot/batch: 14 January, 2000
- Purity test date: 14 January, 2000
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Darkness at approximately 20C in a fume cupboard under inert (N2) conditions
- Stability under test conditions: Confirmed over 4 hours in deionized water
- Solubility and stability of the test substance in the solvent/vehicle: Confirmed over 4 hours in deionized water
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Emulsified in deionized water at appropriate concentrations immediately before use.
FORM AS APPLIED IN THE TEST: Emulsified in deionized water
Method
- Target gene:
- Histidien operon, tryptophan operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver homogenate S9-mix.
- Test concentrations with justification for top dose:
- 50, 160, 500, 1600, 5000 ug/plate. Precipitation of the test article was visible at the 5000 ug/plate dose.
- Vehicle / solvent:
- Deionized water
Controls
- Untreated negative controls:
- yes
- Remarks:
- Untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Deionized water
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)
DURATION
- Preincubation period: Overnight (Approximately 12 hours)
- Exposure duration: 48 hours
- Expression time (cells in growth medium): approximately 60 hours
- Selection time (if incubation with a selection agent): 48 hours
SELECTION AGENT (mutation assays): Histidine or tryptophan-minimal agar
NUMBER OF REPLICATIONS: 2 independent runs (with three plates) of the test article and each control
NUMBER OF CELLS EVALUATED: All revertant colonies on each plate were counted.
DETERMINATION OF CYTOTOXICITY
- Method: Bacterial lawn thinning and a reduction in spontaneously occuring colonies. - Evaluation criteria:
- A test article is classified as mutagenic if it has either of the following effects:
a) it produces at least a 2-fold increase in the mean number of revertants per plat of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control at complete bacterial background lawn.
b)it induces a dose-related increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control in at least two to three concentrations of the test compound at complete bacterial background lawn.
If the test substance does ont achieve either of the above criteria, it is considered to show no evidence of mutagenic activity in this system.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- An increased number of revertants was obtained in the absence of S9 mix, but this effect was not verified by a repeat experiment with finer graduated concentrations and therefore not considered relevant.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the study, the test article was not mutagenic in the Bacterial Reverse Mutation Assay in either the presence or absence of metabolic activation.
- Executive summary:
The mutagenic potential of the test article was evaluated in the Bacterial Reverse Mutation Assay with Salmonella typhimurium (strains: TA100, TA1535, TA1537, and TA98) and Escherichia coli (strain: WP2uvrA) in the presence or absence of metabolic activation. This study was conducted in compliance with OECD GLP guidelines (1999). The study design was based on OECD 471 (1997), US EPA OPPTS 870.5100 (1998), EEC Directive 92/69 L383A Annex B13 and B14. The test article was emulsified in deionized water prior to administration. Two mutagenicity tests were performed with all strains (one plate incorporation test and one preincubation test) each in the presence or absence of metabolic activation (rat liver homogenate). Positive and negative controls were included in all tests. Each bacterial strain was exposed to the test article at up to 5000 ug/plate. A repeat preincubation test was performed with TA1537. The positive and negative controls performed as expected which indicated the tests were valid. A weak increase in the number of revertants was noted in the test article-treated group in strain TA1537 in the absence of metabolic activations. The test article did not increase the number of revertants in the repeat test with TA1537. No increases in the number of revertant colonies were noted in any other strain. Based on the results of the study, the test article was not mutagenic in the Bacterial Reverse Mutation Assay in either the presence or absence of metabolic activation.
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