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EC number: 811-522-0 | CAS number: 62880-93-7
- 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
- Study period:
- 16 December, 2014 - 22 December, 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- (2013)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- (2012)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- sodium 2-methyl-2-{3-[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulfanyl]propanamido}propane-1-sulfonate
- EC Number:
- 811-522-0
- Cas Number:
- 62880-93-7
- Molecular formula:
- C15H17F13NNaO4S2
- IUPAC Name:
- sodium 2-methyl-2-{3-[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulfanyl]propanamido}propane-1-sulfonate
- Test material form:
- other: lumps
- Details on test material:
- - Name of test material (as cited in study report): NS-3000
- Appearance: White to off-white lumps (determined by WIL Research Europe)
- Storage condition of test material: At room temperature desiccated
Constituent 1
Test animals
- Species:
- human
- Details on test animals or test system and environmental conditions:
- ENVIRONMENTAL CONDITIONS
- Temperature (°C): 36.2 - 36.8
- Humidity (%): 81 - 88
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amounts applied: 15.2 to 18.9 mg, 5 μl Milli-Q water to moisten skin.
NEGATIVE CONTOL:
- Amount applied: 25 µl Phosphate buffered saline
POSITIVE CONTROL
- Amount applied: 25 µl
- Concentration: 5% (aq) Sodium dodecyl sulphate - Duration of treatment / exposure:
- 15 minutes
- Details on study design:
- TEST SITE
- EPISKIN Small ModelTM (EPISKIN-SMTM, 0.38 cm2, Lot no.: 14-EKIN-048).
This model is a three-dimensional human epidermis model, which consists of adult human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. The keratinocytes were cultured for 13 days, which results in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
REMOVAL OF TEST SUBSTANCE
- Washing: phosphate buffered saline
- Time after start of exposure: 15 minutes
POST INCUBATION PERIOD
- 42 hours
SCORING SYSTEM:
- Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment. Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: tissue viability
- Value:
- 90
- Remarks on result:
- other:
- Remarks:
- Basis: other: percentage of control. Time point: 15 minutes. Remarks: Negative control = 100%; Positive control = 23%. (migrated information)
In vivo
- Irritant / corrosive response data:
- The relative mean tissue viability obtained after 15 minutes treatment with NS-3000 compared to the negative control tissues was 90%. Since the mean relative tissue viability for NS-3000 was above 50% NS-3000 is considered to be non-irritant.
Any other information on results incl. tables
Test for reduction of MTT by the test substance:
NS-3000 has been tested previously for possible direct MTT reduction and colour interference in the Skin corrosion test using Epiderm as a skin model (WIL project 507115). The solutions were not turned blue / purple and a blue / purple precipitate was not observed. NS-3000 did not interfere with the MTT endpoint.
Acceptability of the assay:
The positive control had a mean cell viability after 15 minutes exposure of 23%. The absolute mean OD570 of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 12%, indicating that the test system functioned properly.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The in vitro skin irritation test was conducted according to OECD 439 guideline and GLP principles.
It is concluded that this test is valid and that NS-3000 is not irritating in the in vitro skin irritation test. - Executive summary:
In an in vitro skin irritation test using a human skin model ( EPISKIN Standard Model), the influence of NS-3000 on the viability of human skin was tested. The test substance was applied directly to 0.38 cm2 cultured skin (15.2 to 18.9 mg, in presence of 5 μl Milli-Q water). After 15 minutes, the substance was removed and cells were cultured for 42 hours. Reliable negative and positive controls were included. The viability of the cells was tested by reduction of MTT. Survival of unexposed skin was set at 100%, the positive control had a mean cell viability of 23% whereas the test substance showed cell viability of 90%. Since the mean relative tissue viability after exposure to the test substance was above 50%, it can be concluded that NS-3000 is not irritating in the in vitro skin irritation test.
Based on the results of this study, the substance does not need to be classified for skin irritation according to Regulation (EC) No 1272/2008 on classification, labelling and packaging.
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