Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 800-035-9 | CAS number: 1374645-21-2
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions. Lack of data on analytical purity of the test substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method, adopted July 2010)
- Deviations:
- yes
- Remarks:
- Lack of data on analytical purity of the test substance.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Landesinstitut für Arbeitsschutz und Produktsicherheit, München
Test material
- Reference substance name:
- niobium oxygen sulfur zinc λ²-stannane
- EC Number:
- 800-035-9
- Cas Number:
- 1374645-21-2
- Molecular formula:
- Sn1.8Zn0.2Nb2O6.8S0.2 (Sn(2-x)Zn(x)Nb2O(7-y)S(y) with x/2 ≤ y, 0.02 ≤ x ≤ 0.22, 0.01 ≤ y ≤ 0.22)
- IUPAC Name:
- niobium oxygen sulfur zinc λ²-stannane
- Details on test material:
- - Name of test material (as cited in study report): Niobium Sulfur Tin Zinc Oxide Lot No. Ex 1455
- Physical state: solid
- Appearance: yellow powder
- Analytical purity: no data
- Lot No.: L1903
- pH value: 6.1
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: EPISKIN-Standard Model™; reconstituted three-dimensional human epidermis
- Details on test animals or test system and environmental conditions:
- TEST SKIN MODEL
- Source: SkinEthic, Lyon, France
TEST METHOD
The model represents a reconstructed three-dimensional skin model based on normal human-derived epidermal keratinocytes which have been cultured to form a multilayered epidermis including basal, spinous and granular layers, and a multi-layered stratum corneum. Irritant materials are identified by their ability to penetrate the stratum corneum and to damage the underlaying cell layers which is determined through a decrease in cell viability as determined by MTT reduction assay.
ADAPTATION TO CELL CULTURE CONDITIONS
Upon receipt, tissues were transferred into 12-well plates containing 2 mL prewarmed assay medium per well and preincubated in a humidified incubator for at least 24 h (37 ± 1 °C, 5% CO2) before use.
INCUBATION CONDITIONS (INCUBATOR)
- Temperature (°C): 37 ± 1
- CO2 gas concentration (%): 5
- Humidity: maximum
Test system
- Type of coverage:
- other: open: in vitro system
- Preparation of test site:
- other: intact reconstructed human epidermis
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Concurrent control tissues treated with PBS served as negative controls, positive controls were exposed to 5% SDS in distilled water.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mg (26.3 mg/cm2) moistened with 10 µL distilled water
CONTROL SUBSTANCES
- Positive control substance: 5% sodium dodecyl sulfate (SDS) in distilled water
- Negative control substance: Phosphate Buffered Saline (PBS) - Duration of treatment / exposure:
- 15 ± 0.5 min
- Observation period:
- Not applicable. Post-treatment period: 42 ± 1 h.
- Number of animals:
- Not applicable. The test was performed in triplicates for each treatment and control group.
- Details on study design:
- TEST SITE
- Area of exposure: 0.38 cm2
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated skin surfaces were washed with PBS to remove the test substance.
- Time after start of exposure: 15 ± 0.5 min
- Post-treatment period: 42 ± 1h
CELL VIABILITY MEASUREMENTS:
For determining alterations in cell viability, MTT reduction assays were performed after the post-treatment period. Therefore, tissues were incubated in 2 mL prewarmed MTT solution for 3 h ± 5 min at 37 ± 1 °C and 5% CO2. After this, the tissues were dried on blotting paper. Extraction of the formazan product was carried out in 0.5 mL acidic isopropanol over the weekend at 2 - 8 °C. The optical density (OD) was measured at 550 nm in a plate spectrophotometer.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: cell viability
- Value:
- 100
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean value of the negative control (PBS). Time point: 15 min. Reversibility: other: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 2.9
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean value of the positive control (5% SDS in distilled water). Time point: 15 min. Reversibility: other: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 92.6
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean value of the test substance in distilled water. Time point: 15 min. Reversibility: other: not applicable. (migrated information)
Any other information on results incl. tables
Table 1: MTT assay after 15 min exposure
Negative Control |
Positive Control |
Test substance |
|||||||
Tissue sample |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
OD550(absolute) |
1.269 1.292 |
1.036 1.050 |
1.107 1.129 |
0.077 0.077 |
0.072 0.077 |
0.075 0.077 |
1.117 1.103 |
1.023 1.047 |
1.065 1.038 |
corrected OD550-blank |
1.225 1.248 |
0.992 1.006 |
1.063 1.085 |
0.033 0.033 |
0.028 0.033 |
0.031 0.033 |
1.073 1.059 |
0.979 1.003 |
1.021 0.994 |
OD550(mean of duplicates) |
1.237 |
0.999 |
1.074 |
0.033 |
0.031 |
0.032 |
1.066 |
0.991 |
1.008 |
OD550(mean of 3 replicates) ± SD |
1.103 ± 0.11 |
0.032 ± 0.00 |
1.022 ± 0.04 |
||||||
Relative tissue viabilities (%) |
112.1 |
90.6 |
97.4 |
3.0 |
2.8 |
2.9 |
96.6 |
89.8 |
91.3 |
Mean tissue viability (%) ± SD |
100.0 ± 11.0 |
2.9 ± 0.1 |
92.6 ± 3.6 |
Blank = 0.044
SD: standard deviation
The MTT assay conducted with the test substance met the test acceptance criteria. Since the tissue viability after exposure and post-treatment incubation period is above 50%, the test substance is considered as non-irritant.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.