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EC number: 279-481-6 | CAS number: 80475-32-7
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- yes
- Remarks:
- Identity, strength, purity and composition or other characteristics to define assay controls, and stability of test article or controls was not determined by the tesing facility. However, COA for controls was provided by the manufacturer.
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-[3-(dimethylamino)propyl]-3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonamide N-oxide
- EC Number:
- 279-481-6
- EC Name:
- N-[3-(dimethylamino)propyl]-3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonamide N-oxide
- Cas Number:
- 80475-32-7
- Molecular formula:
- C13H17F13N2O3S
- IUPAC Name:
- N-[3-(dimethylamino)propyl]-3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonamide N-oxide
- Test material form:
- solid: particulate/powder
- Details on test material:
- Purity: 96.7 %
Constituent 1
- Specific details on test material used for the study:
- Purity: 96.7 %
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: not reported
- Source strain:
- other: human cells
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm(TM) Skin Kit (MatTek Corporation)
- Tissue batch number(s): not reported
- Production date: not reported
- Shipping date: not reported
- Delivery date: not reported
- Date of initiation of testing: 13 February 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
- Temperature of post-treatment incubation (if applicable): standard culture conditions
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: The tissue inserts were filled and emptied 15 times using sterile CMF-DPBS. After the 15th rinse, the cell culture inserts were completely submerged, gently swirled, and rinse media dumped into a beaker containing 150 mL of CMF-DPBS three times. The tissues were rinsed once more on the inside and outside of the cell culture insert with sterile CMF-DPBS from a wash bottle, and the excess CMF-DPBS was decanted.
- Observable damage in the tissue due to washing: none reported
- Modifications to validated SOP: none
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg/mL
- Incubation time: 3±0.1 hours
- Spectrophotometer: Molecular Devices Vmax plate reader with the AUTOMIX function selected
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 3
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be an irritant to skin if the mean relative viability of the three treated tissues is less than or equal to 50% of the mean viability of the negative control. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mg of test substance
- Duration of treatment / exposure:
- 60 ± 1 minutes
- Duration of post-treatment incubation (if applicable):
- 42 ± 2 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 121.6
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: none reported
- Direct-MTT reduction: There was no direct reduction of MTT
- Colour interference with MTT: There was no colour interference
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes (mean OD570 was 1.575)
- Acceptance criteria met for positive control: yes (mean viability was 3.55%)
- Acceptance criteria met for variability between replicate measurements: yes (standard deviation calculated from individual percent tissue viabilities of the 3 identically treated replicates was <18% for the positive control and negative control)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was predicted to be a non-irritant (mean viability was 121.6%).
- Executive summary:
The purpose of this study was to evaluate the skin irritation potential of the test substance. The skin irritation potential was evaluated based upon measuring the relative conversion of MTT (3-[4,5 - dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide) in the test article-treated tissues after exposure to the test article for a 60-minute exposure period, followed by a 42-hour post-exposure expression period. Skin irritation potential of the test article was predicted if the relative viability was less than or equal to 50%. The protocol was based upon the OECD guideline, “In VitroSkin Irritation: Reconstructed Human Epidermis Test Method” (TG439).
The substance was tested in one valid definitive assay to determine the identification and classification of skin irritation hazard according to the UN GHS classification system (Category 1/2 or No Category). The test substance was not observed to directly reduce MTT in the absence of viable cells. The test substance was not determined to be a colorant (was not considered to have potential interference with the MTT measurement. The test substance was predicted not to be a skin irritant with a mean viability of 121.6%.
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