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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
Eye irritation
Administrative data
- Endpoint:
- eye 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 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- 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 %
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Bovine eyes were obtained from a local abattoir as a by-product from freshly slaughtered animals (J.W. TREUTH & SONS, Inc., Baltimore, MD).
- Number of animals: not reported
- Characteristics of donor animals (e.g. age, sex, weight): not reported
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): The eyes were excised and then placed in Hanks' Balanced Salt Solution, containing penicillin/streptomycin (HBSS), and transported to the laboratory on ice packs.
- Time interval prior to initiating testing: Immediately upon receipt of the eyes into the laboratory, preparation of the corneas was initiated.
- indication of any existing defects or lesions in ocular tissue samples: The eyes were grossly examined for damage and those exhibiting defects were discarded.
- Indication of any antibiotics used: eyes were transported in HBSS containing penicillin/streptomycin
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 20% (w/v) solution
- Duration of treatment / exposure:
- 4 hours
- Duration of post- treatment incubation (in vitro):
- 90 minutes
- Number of animals or in vitro replicates:
- 4 replicates for test substance
3 replicates each for negative and positive controls - Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
- The tissue surrounding the eyeball was carefully pulled away and the cornea was excised such that a 2 to 3 mm rim of sclera was present around the cornea. The isolated corneas were then stored in a petri dish containing HBSS until they were mounted in a corneal holder. The corneas were mounted in the holders with the endothelial side against the O-ring of the posterior chamber. The anterior chamber was then positioned on top of the cornea and the screws were tightened. The chambers in the corneal holder were filled with Minimum Essential Medium without phenol red, containing 1% fetal bovine serum and 2 mM L-glutamine (Complete MEM (without phenol red)). The corneal holders were incubated at 32±1°C for a minimum of 1 hour.
QUALITY CHECK OF THE ISOLATED CORNEAS
-After a minimum of 1 hour of incubation, the corneas were removed from the incubator. The medium was removed from both chambers and replaced with fresh Complete MEM (without phenol red). The initial opacity was determined for each cornea using an Electro Designs OP-KIT opacitometer. The treatment of each cornea was identified with the test article number written in permanent marker on colored tape, affixed to each holder. The medium was then removed from the anterior chamber and replaced with the test article, positive control, or negative control.
NUMBER OF REPLICATES
- 3 positive controls, 3 negative controls, 4 corneas with test substance
NEGATIVE CONTROL USED
-Sterile, deionized water
POSITIVE CONTROL USED
- 20% (w/v) dilution of imidazole in Complete MEM without phenol red.
APPLICATION DOSE AND EXPOSURE TIME
- The solid test substance was tested as a 20% (w/v) dilution in sterile, deionized water. An aliquot of 750 μL of the test substance, positive control, or negative control was introduced into the anterior chamber while slightly rotating the holder to ensure uniform distribution over the cornea. Three corneas were incubated in the presence of the negative control at 32 ± 1 ºC for approximately 4 h. Three corneas were incubated in the presence of the positive control at 32 ± 1 ºC for approximately 4 h. Four corneas were incubated in the presence of the test substance at 32 ± 1ºC for approximately 4 h.
TREATMENT METHOD: open chamber
REMOVAL OF TEST SUBSTANCE
- After the 4-hour exposure period, the control or test substance treatments were removed. The epithelial side of the corneas treated with the controls was washed at least three times with Complete MEM (containing phenol red) to ensure total removal of the controls. The corneas were then given a final rinse with Complete MEM (without phenol red). For the corneas treated with the test substance (open chamber technique), the glass window was removed from the anterior chamber and the test substance was rinsed from the treated corneas with Complete MEM (with phenol red). Care was taken not to spray the corneas directly. The chamber windows were returned to the chambers when most or all of the test substance had been removed. The rinsing process continued in the same manner as the positive and negative control corneas. The medium in the posterior chamber was aspirated. The posterior and anterior chambers were refilled with fresh Complete MEM (without phenol red) and then a final opacity measurement was performed immediately (with no further post-exposure incubation).
- Post-exposure incubation:After the final opacity measurement was performed, the medium was removed from the anterior chamber of the holder and replaced with 1 mL of a 5 mg/mL fluorescein solution. The corneas were then incubated in a horizontal position (anterior side up) for approximately 90 minutes at 32 ± 1ºC.
PERMEABILITY
- At the end of the 90-minute incubation period, the medium was removed from the posterior chamber and placed into tubes numbered corresponding to chamber number. Aliquots of 360 μL from the numbered tubes were placed into their designated wells on a 96-well plate. The optical density at 490 nm (OD490) was determined using a Molecular Devices Vmax kinetic microplate reader.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: The change in opacity for each cornea (including the negative control corneas) was calculated by subtracting the initial opacity reading from the final opacity reading. These values were then corrected by subtracting from each the average change in opacity observed for the negative control corneas. The mean opacity value of each treatment group was calculated by averaging the corrected opacity values of each cornea for that treatment condition.
- Corneal permeability: The mean OD490 value for the blank wells was calculated. The mean blank OD490 value was then subtracted from the raw OD490 value of each well (corrected OD490). The final corrected OD490 values of the test substance and the positive control were then calculated by subtracting the average corrected OD490 value of the negative control corneas from the corrected OD490 value of each treated cornea:
Final Corrected OD490 = (raw OD490 – mean blank OD490) – average corrected negative control OD490
The mean OD490 value of each treatment group was calculated by averaging the final corrected OD490 values of the treated corneas for that treatment condition.
- Other: After the medium was removed fro the permeability determination, each cornea was carefully separated from its corneal holder and transferred to an individual labeled tissue cassette containing a biopsy sponge. THe endothelial surface of each cornea was placed on the sponge to protect it. The cassettes were placed in 10% neutral buffered formalin to fix the corneal tissue for at least 24 hours. The fixed corneas will be stored up to one year.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS): In Vitro Score = Mean Opacity Value + (15 x Mean OD490 Value)
DECISION CRITERIA: The BCOP assay was accepted when the positive control (imidazole) caused an In Vitro Score that fell within two standard deviations of the historical mean.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 2.2
- 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
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: Yes
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 1-Octanesulfonamide, N-[3-(dimethyloxidoamino)propyl]-3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro- was determined to have an in vitro score of 2.2, indicating the substance is not an eye irritant.
- Executive summary:
The purpose of this study was to evaluate the potential ocular irritancy of the test substance 1-Octanesulfonamide, N-[3-(dimethyloxidoamino)propyl]-3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-, as measured by changes in opacity and permeability (to fluorescein) in isolated bovine corneas. This study was carried out according to OECD Guideline 437. 4 corneas were treated with the test substance at 32 ± 1ºC for 4 hours. The test substance was determined to have an in vitro score of 2.2, indicating it is not an eye irritant.
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