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EC number: 614-396-3 | CAS number: 68298-12-4
- 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:
- 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Remarks:
- No deviations ocurred that impacted the integrity of the study.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,1,2,2,3,3,4,4,4-nonafluoro-N-methylbutane-1-sulfonamide
- EC Number:
- 614-396-3
- Cas Number:
- 68298-12-4
- Molecular formula:
- C5H4F9NO2S
- IUPAC Name:
- 1,1,2,2,3,3,4,4,4-nonafluoro-N-methylbutane-1-sulfonamide
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material:
3M Company, Lot 3
- Expiration date of the lot/batch:
06 August, 2002
- Purity test date:
30 January, 2002
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
At room temperature in the dark.
- Stability under storage conditions:
Stable
- Stability under test conditions:
Stable
- Solubility and stability of the test substance in the solvent/dispersant/vehicle/test medium:
Stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
The test article was suspended in DMSO
- Final preparation of a solid:
Suspended in DMSO
FORM AS APPLIED IN THE TEST: Suspended in DMSO
Method
- Target gene:
- Tryptophan and hisitdine operons
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:
- Type and composition of metabolic activation system:
- source of S9 : Aroclor-1254 induced rat liver S9-mix
- method of preparation of S9 mix: Rat liver microsomal enzymes were routinely prepared from adult male Wistar rats, which were obtained from Charles River, Sulzfeld, Germany.
- concentration or volume of S9 mix and S9 in the final culture medium: 5% v/v in the first experiment and 10% v/v in the second experiment.
- quality controls of S9: Before use, all Sg-batches were characterized with the metabolic activation requiring positive control; benzo[a]pyrene (Sigma) in tester strain TA98 at the concentration of 5 ug/plate - Test concentrations with justification for top dose:
- 3, 10, 33, 100, 333, 1000, 3330, 5000 ug/plate. The top dose is the limit dose per OECD 471.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Test article and test system compatibility.
- Justification for percentage of solvent in the final culture medium: No data
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- other: daunomycine, 2-aminoanthracene
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: Triplicate
- Number of independent experiments : 2
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): 10^9 cells/mL
- Test substance added in agar (plate incorporation)
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: None
- Exposure duration/duration of treatment: 48 hours
- Harvest time after the end of treatment (sampling/recovery times): Colonies were counted following the 48 hour exposure.
FOR GENE MUTATION:
- Expression time (cells in growth medium between treatment and selection): 48 hours.
- Selection time (if incubation with a selective agent): 48 hours (Histidine and tryptophan-minimal agar)
- Fixation time (start of exposure up to fixation or harvest of cells): 48 hours
- If a selective agent is used (e.g., 6-thioguanine or trifluorothymidine), indicate its identity, its concentration and, duration and period of cell exposure: Histidine and tryptophan-minimal agar.
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method.: background growth inhibition
METHODS FOR MEASUREMENTS OF GENOTOXICIY : See "Evaluation Criteria" section.
- Rationale for test conditions:
- Per OECD 471.
- Evaluation criteria:
- No formal hypothesis testing was done.
A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in any tester strain at any concentration is not greater than two times the solvent control value, with or without metabolic activation.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if:
a) It induces a number of revertant colonies, dose related, greater than two-times the number of revertants induced by the solvent control in any of the tester strains, either with or without metabolic activation.
However, any mean plate count of less than 20 is considered to be not significant.
b) The positive response should be reproducible in at least one independently repeated experiment. - Statistics:
- No data
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxicit4y was observed at 5000 ug/plate.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxicity was observed at 3330 ug/plate and greater.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxicity was observed at 5000 ug/plate.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxicity was observed at 3330 ug/plate and greater.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- 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:
- cytotoxicity
- Remarks:
- Cytotoxicity was observed at 5000 ug/plate.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Data on pH: None
- Data on osmolality: None
- Possibility of evaporation from medium: The test article is a solid suspended in a vehicle. Evaporation is not expected/possible
- Water solubility: No data
- Precipitation and time of the determination: No precipitation was observed.
RANGE-FINDING/SCREENING STUDIES (if applicable): The range-finding study was included as the first portion of the first mutation experiment.
STUDY RESULTS
- Concurrent vehicle negative and positive control data : The negative and strain-specific positive control values were within our laboratory background historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
For all test methods and criteria for data analysis and interpretation:
- Concentration-response relationship where possible : No dose-related, two-fold, increase in the number of revertants was observed in two independently repeated experiments.
- Statistical analysis; p-value if any - No data
Ames test:
- Signs of toxicity : Toxicity (reduction of the bacterial background lawn and reduction in the number of revertants) was observed inall stains at 3330 and/or 5000 ug/plate in the presence and absence of S9-mix.
- Individual plate counts : See attached results tables for summary.
- Mean number of revertant colonies per plate and standard deviation : See attached results tables for summary.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation, and 95% control limits for the distribution as well as the number of data)
- Positive historical control data: See attached table.
- Negative (solvent/vehicle) historical control data: See attached table.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the test article is not mutagenic in the Bacterial Reverse Mutation Assay in the presence or absence of metabolic activation.
- Executive summary:
The mutagenic potential of the test article (off white solid, Lot 3) was evaluated in the Bacterial Reverse Mutation Assay with S. typhimurium strains TA98, TA100, TA1535, and TA1537 and E. coli strain WP2uvrA in the presence and absence of metabolic activation (S9-mix:Aroclor-1254 induced rat liver). This study was performed in compliance with OECD GLP. The study method was based on OECD 471 (1997) and EEC Directive 67/548/EEC B.13-14 (2000). The test article was prepared in dimethyl sulfoxide just prior to administration to the cells. In the dose range-finding test, the test article was tested at up to 5000 ug/plate in TA100 and WP2uvrA in the presence and absence of S9-mix. In the mutation assays, the test article was tested at up to 5000 ug/plate in each strain in the presence and absence of S9-mix. Strain-specific positive controls were tested in parallel. Each treatment was performed in triplicate. Toxicity (reduction of the bacterial background lawn and reduction in the number of revertants) was observed in all stains at 3330 and/or 5000 ug/plate in the presence and absence of S9-mix. No reproducible, dose-related increase in the number of revertant colonies was observed in any strain at any dose in the presence or absence of S9-mix. All criteria for a valid study were met. Under the conditions of this study, the test article is not mutagenic in the Bacterial Reverse Mutation Assay in the presence or absence of metabolic activation.
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