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EC number: 609-534-4 | CAS number: 382-26-3
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 February 2005 to 28 April 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Guideline-conform study under GLP without deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,1,1,3,3-pentafluoro-3-methoxy-2-(trifluoromethyl)propane
- EC Number:
- 609-534-4
- Cas Number:
- 382-26-3
- Molecular formula:
- C5H4F8O
- IUPAC Name:
- 1,1,1,3,3-pentafluoro-3-methoxy-2-(trifluoromethyl)propane
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Octafluoroisobutyl methyl ether
- Substance type: pure substance
- Physical state: liquid
- Analytical purity: > 86%
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: not reported
- Isomers composition: not reported
- Purity test date: not reported
- Lot/batch No.: 20/01/04-161
- Expiration date of the lot/batch: 31 December 2006
- Stability under test conditions: not reported
- Storage condition of test material: 2°C -8°C
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix
- Test concentrations with justification for top dose:
- Experiment I (TA 98, TA 100): 3; 10; 33; 100; 333; 1000; 2500; 5000 microgram/plate
Experiment I (plate incorporation test): 33; 100; 333; 1000; 3500; 5000 microgram/plate
Experiment II (pre-incubation test): 10 ; 33; 100; 333; 1000; 2500; 5000 microgram/plate
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethyl Sulfoxide (DMSO)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 2-aminoantracece; 4-nitro-o-phenylenediamina
- Evaluation criteria:
- A test item is considered as mutagen if a biologically relevant increase in the number of revertants exceeding the treshold of twice (strains TA 98, TA 100 and TA 102) or three times (strains TA 1535 and TA 1537) the colony count of the corrisponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the treshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant.
ACCEPTABILITY OF THE ASSAY
The Salmonella Typhimurium reverse mutation assay is considered acceptable if it meets the following criteria:
- regular background growth in the negative and solvent control
- the spontaneous reversion rates in the negative and solvent control are in the range of our historical data
- the positive control substances should produce a significant increase in mutant colony frequencies - Statistics:
- Statistical analysis of data was not performed.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- toxicity was observed at highest tested doses
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Experiment I (plate incorporation test)
Any other information on results incl. tables
In both experiments, reduced background growth was observed with and without S9 mix in all strains used.
Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5) were observed at the following concentrations (microgram/plate).
|
EXPERIMENT I |
EXPERIMENT II |
||
Strain |
without S9 mix |
with S9 mix |
without S9 mix |
with S9 mix |
TA 1535 |
5000 |
5000 |
2500 |
1000, 5000 |
TA 1537 |
333, 5000 |
5000 |
333, 1000 |
1000 - 5000 |
TA 98 |
// |
// |
1000 - 5000 |
2500 |
TA 100 |
5000 |
// |
1000 - 5000 |
1000 - 5000 |
TA 102 |
2500, 5000 |
2500, 5000 |
1000 - 5000 |
1000 - 5000 |
// = no toxic effects observed
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with 2-[difluoro(methoxy)methyl]-1,1,1,3,3,3-hexafluoropropane at any concentration level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged of biological relevance.
Appropriate reference mutagens were used as positive controls. They showed a distinct increase in induced revertant colonies.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Applicant's summary and conclusion
- Conclusions:
- 2-[difluoro(methoxy)methyl]-1,1,1,3,3,3-hexafluoropropane is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.
- Executive summary:
This study was performed to investigate the potential of 2-[difluoro(methoxy)methyl]-1,1,1,3,3,3-hexafluoropropane to induce gene mutations according to the plate incorporating test (experiment I) and the pre-incubation test (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, TA 102.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item eas tested at the following concentrations:
Experiment I (TA 98, TA 100): 3; 10; 33; 100; 333; 1000; 2500; 5000 microgram/plate
Experiment I : 33; 100; 333; 1000; 3500; 5000 microgram/plate
Experiment II : 10 ; 33; 100; 333; 1000; 2500; 5000 microgram/plate
In both experiments, reduced background growth was observed with and without S9 mix in all strains used.
Toxic effect, evident as a reduction in the number of revertants, were observed at higher concentrations with and without metabolic activation in nearly all strains used.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with 2-[difluoro(methoxy)methyl]-1,1,1,3,3,3-hexafluoropropane at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes of frameshifts in the genome of the strains used.
Therefore, 2-[difluoro(methoxy)methyl]-1,1,1,3,3,3-hexafluoropropane is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.
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