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EC number: 811-523-6 | CAS number: 88992-45-4
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 April, 2015 - 01 May, 2015
- 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 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- (2014)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Version / remarks:
- (2008)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- {2-hydroxy-3-[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulfanyl]propyl}trimethylazanium chloride
- EC Number:
- 811-523-6
- Cas Number:
- 88992-45-4
- Molecular formula:
- C14 H19 F13 N O S . Cl
- IUPAC Name:
- {2-hydroxy-3-[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulfanyl]propyl}trimethylazanium chloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): NS-4000
- Appearance: Off-white powder (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): 36.4 - 36.7
- Humidity (%): 75 - 87
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amounts applied: 25.1 to 28.8 mg, 25 μL Milli-Q water to moisten skin.
NEGATIVE CONTOL:
- Amount(s) applied (volume or weight with unit): 50 µL Milli-Q water
POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 50 µL KOH
- Concentration (if solution): 8 N - Duration of treatment / exposure:
- Exposure: 3 minutes and 1 hour
Post incubation period: 42 hours - Details on study design:
- TEST SITE
EpiDerm Skin Model (EPI-200, Lot no.: 22226 kit N). The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm tissues (surface 0.6 cm²) were cultured on polycarbonate membranes of 10 mm cell culture inserts.
REMOVAL OF TEST SUBSTANCE
- Washing: phosphate buffered saline
- Time after start of exposure: 3 minutes and 1 hour
POST INCUBATION PERIOD
- 42 hours
SCORING SYSTEM:
Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) at the end of the treatment. Cell viability was calculated for each tissue as percentage of the mean of the negative control tissues.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: percentage viability
- Value:
- 89
- Remarks on result:
- other:
- Remarks:
- Basis: other: percentage of control. Time point: 3 minutes. Remarks: Negative control = 100%; Positive control = 14% . (migrated information)
- Irritation / corrosion parameter:
- other: other: percentage viability
- Value:
- 97
- Remarks on result:
- other:
- Remarks:
- Basis: other: percentage of control. Time point: 1 hour. Remarks: Negative control = 100%; Positive control = 7%. (migrated information)
In vivo
- Irritant / corrosive response data:
- The relative mean tissue viability obtained after the 3-minute and 1-hour treatments with NS-4000 compared to the negative control tissues was 89% and 97%, respectively. Because the mean relative tissue viability for NS-4000 was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment NS-4000 is considered to be not corrosive.
- Other effects:
- NS-4000 was checked for colour interference in aqueous conditions and possible direct MTT reduction by adding the test substance to MTT medium. Because the solutions did not turn blue / purple and a blue / purple precipitate was not observed it was concluded that NS-4000 did not interfere with the MTT endpoint.
Any other information on results incl. tables
Acceptability of the assay:
The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The mean relative tissue viability following 3-minute exposure to the positive control was 14%. The maximum inter-tissue variability in viability between two tissues treated identically was less than 22% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 13%. It was therefore concluded 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 corrosion test was conducted according to OECD 431 guideline and GLP principles.
It is concluded that this test is valid and that NS-4000 is not corrosive in the in vitro skin corrosion test.
- Executive summary:
In a reliable in vitro skin corrosion test using a human skin model (EpiDerm Skin Model), the influence of NS-4000 on the viability of human skin was tested. The test substance was applied directly to 0.6 cm^2 cultured skin (25.1 to 28.8 mg, in presence of 25 μL Milli-Q water). After 3 minutes and 1 hour exposure, 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 14 and 7% whereas the test substance showed cell viability of 89 and 97%, for the 3-minute and 1 hour exposure respectively. Since the mean relative tissue viability for NS-4000 was not below 50% after the 3 -minute treatment and not below 15% after the 1-hour treatment, NS-4000 is considered to be not corrosive in the in vitro skin corrosion test.
Based on the results of this study, the substance does not need to be classified for skin corrosion according to Regulation (EC) No 1272/2008 on classification, labelling and packaging.
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