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EC number: 663-306-9 | CAS number: 12031-75-3
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dipotassium oxide
- EC Number:
- 235-227-6
- EC Name:
- Dipotassium oxide
- Cas Number:
- 12136-45-7
- Molecular formula:
- K2O
- IUPAC Name:
- Potassium oxide
- Reference substance name:
- Disodium oxide
- EC Number:
- 215-208-9
- EC Name:
- Disodium oxide
- Cas Number:
- 1313-59-3
- Molecular formula:
- Na2O
- IUPAC Name:
- sodium oxide
- Reference substance name:
- Lithium sulphate
- EC Number:
- 233-820-4
- EC Name:
- Lithium sulphate
- Cas Number:
- 10377-48-7
- Molecular formula:
- H2O4S.2Li
- IUPAC Name:
- dilithium sulfate
- Reference substance name:
- Nickel monoxide
- EC Number:
- 215-215-7
- EC Name:
- Nickel monoxide
- Cas Number:
- 1313-99-1
- Molecular formula:
- NiO
- IUPAC Name:
- Nickel (II) oxide
- Reference substance name:
- dilithium manganese nickel tetraoxide
- Cas Number:
- 128975-24-6
- Molecular formula:
- Li2MnNiO4
- IUPAC Name:
- dilithium manganese nickel tetraoxide
- Reference substance name:
- dilithium trimanganese nickel octaoxide
- EC Number:
- 663-306-9
- Cas Number:
- 12031-75-3
- Molecular formula:
- Li2Mn3NiO8
- IUPAC Name:
- dilithium trimanganese nickel octaoxide
- Test material form:
- solid: particulate/powder
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
Constituent 1
- Specific details on test material used for the study:
- Batch no 2021083735
In vitro test system
- Test system:
- other: Reconstructed Human Epidermis (RHE), EpiDerm is a ready-to-use, highly differentiated 3D tissue model consisting of normal, human-derived epidermal keratinocytes (NHEK) cultured on specially prepared tissue culture inserts.
- Source species:
- human
- Justification for test system used:
- In OECD Test Guideline No. 431 EpiDerm™ Skin Corrosivity Test (SCT) (EPI-200 and EPI-212) is referred to as a Validated Reference Method that – based on prevalidation studies, followed by a formal validation study for assessing skin corrosion – could be used for regulatory purposes.
- Details on test system:
- The reconstructed human epidermal model EpiDerm™ (EPI-200 and EPI-212, MatTek, Ashland, MA, USA and Bratislava, Slovakia) consists of normal human-derived epidermal keratinocytes, which have been cultured to form a multi-layered, 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. A generic description of general and functional conditions that reconstructed human skin models need to comply with can be found in the new OECD Test Guidelines No. 431 In Vitro Skin Corrosion: Reconstructed Human Epidermis (RhE) Test Method and No. 439 In vitro Skin Irritation: Reconstructed Human Epidermis Test Methods.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- First, 25 µL of sterile deionized water was applied to the epidermal surface in order to improve further contact between powder and epidermis. Subsequently, approximately 25 mg of the test item was applied evenly to the epidermal surface. The test item was spread gently on the skin surface with a curved flat spatula without damaging the epidermis. The insert was gently shaken from side to side to ensure that tissue was completely covered by the test item.
- Duration of treatment / exposure:
- 1 hour + 3 min
- Number of replicates:
- 2 replicates of test item, 2 replicates of negative control, 2 replicates of positive control, 2 replicates of colour controls (NSCliving), 2 test item treated killed tissues for non-specific colour control (NSCkilled), 2 killed test item treated tissues and 2 killed negative control treated tissues were used for the MTT evaluation.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean
- Value:
- 96
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, in this in vitro skin corrosion test in the EpiDermTM model (OECD 431) with LNMO cathode material the results indicate that the test item is not corrosive. According to the UN GHS classification system, LNMO cathode material has been categorized as “Non-corrosive”.
- Executive summary:
Disks of EpiDermTM (two units / chemical / incubation time) were treated with the test item and incubated for 60 minutes (+ 3 min) at standard culture condition (37±1 °C in an incubator with 5±1 % CO2 in a 95±1 % % humidified atmosphere) and for 3 minutes at room temperature. Exposure of test material was terminated by rinsing with 1x DPBS solution. The viability of each disk was assessed by incubating the tissues for 3 hours (±5 min) with MTT solution at 37±1 °C in an incubator with 5±1 % CO2 in a 95±1 % humidified atmosphere and protected from light. An exception were the additional colour controls (NSCliving and NSCkilled), which wells were filled up with 300 µL assay medium (instead of MTT ready to use solution), the other steps remained the same. The formazan precipitated was then extracted using MTT-100-EXT (extractant solution) and quantified spectrophotometrically.
Potassium hydroxide (KOH) 8N solution and sterile deionized water treated (two units / positive and negative control) epidermis were used as positive and negative controls, respectively in the experiment.
The test item is a possible MTT-reducer, therefore additional controls (two test item treated killed tissues and two negative control treated killed tissues) were used to detect and correct for test item interference with the viability measurement in each exposure time. The mean non-specific MTT reduction (NSMTT) was determined to be 0* % at 60 minutes exposure and 0*% at 3 minutes exposure.
*: The calculated NSMTT was -1% and -4% at 60 and 3 minutes exposure. However, for the calculation of non-specific MTT reduction, small negative numbers are counted as zero, because the reason of the small negative number is a slight difference between the used killed epidermis (biological variability).
The test item has an intrinsic colour (grey/black), therefore two additional test item treated tissues were used for the non-specific OD evaluation (NSCliving).
The test item is a MTT-reducer and has an intrinsic colour (grey/black). To avoid a possible double correction [TODTT (MTT and NSCliving)] for colour interference, a third control for non-specific colour in killed tissues (NSCkilled) was performed. However, as the NSCliving % was 2 % and 1 % (below 5 %) at 60 and 3 minutes exposure and the non-specific MTT reduction (NSMTT) was determined to be 0 % in both exposure times, so the NSCkilled was not determined and used during the calculation of true MTT metabolic conversion in each exposure time.
For each treated tissue viability was expressed as a % relative to negative control. The test item is considered to be non-corrosive to skin, if the mean relative viability after 60 minutes of exposure is above or equal to 15 % and the mean relative viability after 3 minutes of exposure is above or equal to 50 % of the negative control.
The test item did not show significantly reduced cell viability in comparison to the negative control after 60 and 3 minutes exposure. The average test item treated tissue mean viability was 96 % at 60 minutes of exposure and the mean viability was 93 % at 3 minutes of exposure.
Positive and negative controls showed the expected optical density (OD) in the experiment and cell viability values within acceptable limits. All assay acceptance criteria were met, the experiment was considered to be valid.
In conclusion, in this in vitro skin corrosion test in the EpiDermTM model (OECD 431) with LNMO cathode material the results indicate that the test item is not corrosive. According to the UN GHS classification system, LNMO cathode material has been categorized as “Non-corrosive”.
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