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EC number: 234-744-4 | CAS number: 12030-85-2
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-09-11 to 2017-10-18
- 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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- Adopted 29th July, 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Potassium niobate
- EC Number:
- 234-744-4
- EC Name:
- Potassium niobate
- Cas Number:
- 12030-85-2
- Molecular formula:
- K.NbO3
- IUPAC Name:
- niobium(5+) potassium trioxidandiide
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The EpiDerm Skin Model is a well-established organotypic, three-dimensional model of the human epidermis and is used for in vitro experiments since many years. It is known for its similarity to human skin.
- Vehicle:
- water
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm^TM
- Tissue bach number(s): 20171402
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation (if applicable): MTT assay plate incubated at 37+/- 1 °C
EpiDerm Kit:
The EpiDerm^TM tissues were provided as kits (e.g. EPI-200; MatTek), consisting of the following components relevant for this study:
1x sealed plate containing e.g. 24 reconstructed epidermis units (area: 0.63 cm2); each reconstructed epidermis is attached to a cell culture insert and maintained on nutritive agar for transport (Lot: 25841)
2x 24-well plates
4x 6-well plates
1x bottle of assay medium (DMEM-based medium; Lot: 090717TMC)
1x bottle of DPBS Rinse Solution (Lot: 062717MGKA)
25 pieces Nylon Mesh circles (8 mm diameter, 200 µm pore)
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: Using a wash bottle, the tissue will be gently rinsed about 20 times with PBS (phosphate buffered saline) to remove any residual test item
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: MTT stock solution with 5 mg/mL MTT in PBS, diluted 1 + 4 with DMEM-based medium (final concentration: 1 mg/mL)
- Incubation time: 1h
- Spectrophotometer: plate spectrophotometer
- Wavelength: 570 nm
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION:
The test is performed on a total of 4 tissues per dose group, 2 replicas for each treatment period (3 min and 60 min exposure time).
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERNCE
- killed tissue
- N. of replicates: two tissues per treatment period were treated with 25 mg of the test item (KT) and two killed tissues were left untreated
- Method of calculation used: The non-specific colour of additional killed tissues (NSCkilled) was calculated according to: NSCkilled [%] = [ODTKT/ODNK]*100
The true tissue viability is then calculated as the percent tissue viability obtained with living tissues minus NSMTT minus NSCliving plus NSCkilled.
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
A test item is classified as non-corrosive if both of the following statements hold true: mean tissue viability after 3 min and 60 min treatment is not decreased to less than 50% and 15% of the corresponding negative control tissues, respectively.
A test item is classified corrosive (C, in accordance with UN GHS category 1) in any case, if the mean tissue viability after 3 min treatment is decreased below 50%: if viability is reduced to less than 50% after 3 min treatment and to more than 15% after 60 min treatment. A test item which decreases viability below 25% after 3 min treatment is classifed as corrosive in accordance with optional UN GHS sub-category 1A. - Control samples:
- yes, concurrent negative control
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Name: Potassium niobate
- Batch No.: 20171402
- CAS No.: 12030-85-2
- Aggregate state at RT: solid powder
- Colour: white
- Storage conditions: RT, stored in tightly closed container
- Expiry Date: 22 August 2019
- Amount(s) applied (volume or weight with unit): 25 mg of the test substance mixed per 1 mL MTT medium was applied directly atop the EpiDerm^TM tissue.
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL distilled water
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL 8 N KOH - Duration of treatment / exposure:
- 3 min and 60 min
20 sec. betweeen dosin - Duration of post-treatment incubation (if applicable):
- 3 h MTT incubation period
- Number of replicates:
- 2 tissues per dose group and time point
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3 mins exposure
- Run / experiment:
- Mean of replicates
- Value:
- 88.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 60 minutes exposure
- Run / experiment:
- Mean of replicates
- Value:
- 91.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no 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 to the skin. The relative mean tissue viability after 3 min 60 min of exposure was > 50%. The test item is therefore considered "non-corrosive” in accordance with UN GHS.
- Executive summary:
In a skin corrosion study conducted according to OECD guideline 431, the EpiDerm™-Model was topically exposed to Potassium niobate (Purity > 99.8 %) for 3 mins and 60 mins. Corrosive potential of the test item was predicted from the relative mean tissue viabilities obtained compared to the corresponding negative control tissues concurrently treated with DPBS. The mean relative tissue viability (% negative control) was > 50% (88.3%) after 3 min treatment and > 15% (91.4%) after 60 min treatment. Based on this result, the test item is classified as a non-corrosive according to the UN GHS..
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