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EC number: 242-159-0 | CAS number: 18282-10-5
- 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:
- from 7th February 2012 to 10th February 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD No. 431. In vitro skin corrosion:Human skin model test.13 April 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tin dioxide
- EC Number:
- 242-159-0
- EC Name:
- Tin dioxide
- Cas Number:
- 18282-10-5
- Molecular formula:
- O2Sn
- IUPAC Name:
- tin(4+) dioxidandiide
- Test material form:
- solid: nanoform
- Details on test material:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material:
2012-000203
- Expiration date of the lot/batch:
07/02/2013, W0167
- Purity test date:
> 99.9%, 23/01/2011
INFORMATION ON NANOMATERIALS
- Chemical Composition:
Tin Dioxide
- Density:
6.936 g/cm³
- Particle size & distribution:
10-100 nm; 78
- Specific surface area: 7.4293 ± 0.0132 m²/g
1
In vitro test system
- Test system:
- human skin model
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
Test animals
- Species:
- other: human skin models: EpiDerm(TM)
- Strain:
- other: human skin models: EpiDerm(TM)
- Details on test animals or test system and environmental conditions:
- not applicable
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: not applicable
- Vehicle:
- water
- Controls:
- other: not applicable
- Amount / concentration applied:
- 25 mg of the test item was applied directly atop the EpiDermTM tissue using an application spoon avoiding compression of the test item. To ensure good contact with the skin the test item was moistured with 25 µl of water. The test item was spead to match size of the tissue.
- Duration of treatment / exposure:
- 3 and 60 minutes.
- Observation period:
- one single application.
- Number of animals:
- not applicable
- Details on study design:
- Upon receipt of the EpiDermTM - kit, the tissues were transferred into 6-well plates containing 900 µL prewarmed assay medium per well. The 6-well plates were pre-incubated in a humidified incubator at 37 ± I °C, 5.0% CO2 / 95% air for at least 1 h. Then the medium was replaced by 900 µL fresh assay medium. The 6-well plate used for the 3 min. experiment was placed back into the incubator. The other plate was used for the 60 min treatment. About 1 h before the end of the first treatment period the MTT solution was prepared by mixing the MT’ concentrate with the MTT diluent and pre-warmed in the incubator.
60 min experiment: the tissues were treated with each dose group in duplicate, starting with the negative control. Start time was recorded with dosing of the first tissue. Then the 6-well plate was incubated at 37 ± 1 °C, 5.0% CO2 / 95% air.
3 min experiment: the tissues were treated with each dose group in duplicate, starting with the negative control. Start time was recorded with dosing of the first tissue. A constant time interval of 20 sec. was kept between dosing.
After 3 min of application, with foreceps, the first insert was removed from the 6-well plate. Using a wash bottle the tissue was gently rinsed about 20 times with PBS (phosphate buffered saline) to remove any residual test item. Excess PBS was removed by gently shaking the insert and blotting bottom with blotting paper. The insert was placed in a prepared 24-well “holding plate” containing 300 µL prewarmed assay medium per well. All inserts were treated in the same manner.
Then the inserts were transferred into a prepared 24-well “MTT assay plate” containing 300 µL prewarmed MTT solution. The plate was incubated for 3 h at 37 ± I °C, 5.0% CO2 / 95% air.
60 min experiment: after 60 min application, with foreceps, the first insert was removed from the 6-well plate. Using a wash bottle the tissue was gently rinsed about 20 times with PBS to remove any residual test item. Excess PBS was removed by gently shaking the insert and blotting bottom with blotting paper. All inserts were treated in the same manner.
Then the inserts were transferred into a prepared 24-well “MIT assay plate” containing 300 µL prewarmed MTT solution. The plate was incubated for 3 h at 37 ± 1 DC, 5.0% CO2 / 95% air.
3 min and 60 min experiment: after the 3 h MTT incubation period the MTT solution was aspirated. The wells were refilled with PBS and the PBS was aspirated. The rinsing was repeated twice and the tissues were dried. Then the inserts were transferred into new 24-well “extraction plates”. 2 mL of isopropanol were pipetted into each insert, thus the insert was covered from both sides. The extraction plates were sealed in zip-bags to inhibit isopropanol evaporation. Extraction was carried out over night without shaking at room temperature.
After the extraction period the inserts were pierced with an injection needle to allow the extracts to run through the tissues into the corresponding wells. Then the inserts were discarded and the extraction plates were placed on a shaker for 15 mm.
Per each tissue 3 x 200 µL aliquots of the extract were transferred into a 96-well plate and OD was measured at 550 nm without reference wavelength in a plate spectrophotometer.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test item
- Value:
- ca. 99
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Negative control
- Value:
- ca. 100
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- positive control
- Value:
- ca. 15
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no corrosive effects. The test item is classified as "non corrosive".
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