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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics 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
- Objective of study:
- bioaccessibility (or bioavailability)
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Standard Operating Procedure (SOP) for Bioelution Testing of Metals, Inorganic Metal Compounds, and Metal-Containing Complex Materials: Simulated Gastric Fluid (Eurometaux, November 2 2019)
- GLP compliance:
- no
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: 2017431383
Results and discussion
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- In the test item vessels with a loading of 0.2 g/L LNMO, the following average dissolved element concentrations of:
• 0.510 ± 0.006 mg/L Li (CVbetween-vessel = 1 %; N = 3) or 2.55 ± 0.03 mg/g test item,
• 1.45 ± 0.02 mg/L Mn (CVbetween-vessel = 1 %; N = 3) or 7.22 ± 0.08 mg/g test item,
• 0.366 ± 0.010 mg/L Ni (CVbetween-vessel = 3 %; N = 3) or 1.83 ± 0.05 mg/g test item,
was measured after 2 hours of exposure to the simulated gastric fluid (pH 1.5).
Based on the specific surface area of LNMO (i.e. 0.2 m²/g), this corresponds to an element release per surface of:
• 13 mg/m² lithium,
• 36 mg/m² manganese,
• 9.1 mg/m² nickel.
Based on the element contents (i.e. 3.87 % Li, 44.7 % Mn and 14.9 % Ni) in the test item and the average dissolved element concentrations in the test solutions, a release of:
• lithium of 6.6 % of the content,
• manganese of 1.6 % of the content,
• nickel of 1.2 % of the content,
could be calculated at the 2 hours endpoint.
In the test item vessels with a loading of 2 g/L LNMO, the following average dissolved element concentration of:
• 5.44 ± 0.09 mg/L Li (CVbetween-vessel = 2 %; N = 3) or 2.72 ± 0.05 mg/g test item,
• 14.1 ± 0.5 mg/L Mn (CVbetween-vessel = 3 %; N = 3) or 7.03 ± 0.24 mg/g test item,
• 3.64 ± 0.03 mg/L Ni (CVbetween-vessel = 1 %; N = 3) or 1.82 ± 0.02 mg/g test item,
was measured after 2 hours of exposure to the simulated gastric fluid (pH 1.5).
Based on the specific surface area of LNMO (i.e. 0.2 m²/g), this corresponds to an element release per surface of:
• 14 mg/m² lithium,
• 35 mg/m² manganese,
• 9.1 mg/m² nickel.
Based on the element contents (i.e. 3.87 % Li, 44.7 % Mn and 14.9 % Ni) in the test item and the average dissolved element concentrations in the test solutions, a release of:
• lithium of 7.0 % of the content,
• manganese of 1.6 % of the content,
• nickel of 1.2 % of the content,
could be calculated at the 2 hours endpoint.
Applicant's summary and conclusion
- Conclusions:
- In the test item vessels with a loading of 0.2 g/L LNMO, the following average dissolved element concentrations of:
• 0.510 ± 0.006 mg/L Li (CVbetween-vessel = 1 %; N = 3) or 2.55 ± 0.03 mg/g test item,
• 1.45 ± 0.02 mg/L Mn (CVbetween-vessel = 1 %; N = 3) or 7.22 ± 0.08 mg/g test item,
• 0.366 ± 0.010 mg/L Ni (CVbetween-vessel = 3 %; N = 3) or 1.83 ± 0.05 mg/g test item,
was measured after 2 hours of exposure to the simulated gastric fluid (pH 1.5).
Based on the specific surface area of LNMO (i.e. 0.2 m²/g), this corresponds to an element release per surface of:
• 13 mg/m² lithium,
• 36 mg/m² manganese,
• 9.1 mg/m² nickel.
Based on the element contents (i.e. 3.87 % Li, 44.7 % Mn and 14.9 % Ni) in the test item and the average dissolved element concentrations in the test solutions, a release of:
• lithium of 6.6 % of the content,
• manganese of 1.6 % of the content,
• nickel of 1.2 % of the content,
could be calculated at the 2 hours endpoint.
In the test item vessels with a loading of 2 g/L LNMO, the following average dissolved element concentration of:
• 5.44 ± 0.09 mg/L Li (CVbetween-vessel = 2 %; N = 3) or 2.72 ± 0.05 mg/g test item,
• 14.1 ± 0.5 mg/L Mn (CVbetween-vessel = 3 %; N = 3) or 7.03 ± 0.24 mg/g test item,
• 3.64 ± 0.03 mg/L Ni (CVbetween-vessel = 1 %; N = 3) or 1.82 ± 0.02 mg/g test item,
was measured after 2 hours of exposure to the simulated gastric fluid (pH 1.5).
Based on the specific surface area of LNMO (i.e. 0.2 m²/g), this corresponds to an element release per surface of:
• 14 mg/m² lithium,
• 35 mg/m² manganese,
• 9.1 mg/m² nickel.
Based on the element contents (i.e. 3.87 % Li, 44.7 % Mn and 14.9 % Ni) in the test item and the average dissolved element concentrations in the test solutions, a release of:
• lithium of 7.0 % of the content,
• manganese of 1.6 % of the content,
• nickel of 1.2 % of the content,
could be calculated at the 2 hours endpoint. - Executive summary:
Bioelution refers to the in vitro extraction methods used to measure the degree to which a substance (e.g., metal or mineral ion) is dissolved in artificial biological fluids. Simulated biological fluids represent relevant exposure routes. The release/dissolution of lithium, manganese and nickel ions from LNMO in the simulated gastric fluid was measured.
The resulting value is the “bioaccessibility” and is defined as the “fraction of a substance that is soluble under physiological conditions and therefore potentially available for absorption into systemic circulation”.
This study was conducted according to The Standard Operating Procedure for Bioelution Testing of Metals, Inorganic Metal Compounds, and Complex Metal-Containing Materials: Simulated Gastric Fluid (Eurometaux, November 2, 2019) in which the gastric medium will be prepared starting from a 0.1 M HCl solution.
The extent of dissolution of LNMO in the powder form (as received) was tested in a simulated gastric fluid at 37 °C and pH 1.5 for 2 hours (0.2 g/L and 2 g/L loadings) at an agitation speed of 100 revolutions per minute (rpm) for 1 hour followed by 1 hour of settling (without shaking). The bioelution endpoint is based on the dissolved lithium, manganese and nickel concentrations obtained after 2 hours of extraction.
The study was performed at ECTX. Analysis of the concentrations of dissolved lithium, manganese and nickel has been performed at WLN Business B.V. (The Netherlands), an ISO 17025 accredited laboratory, as delegated by ECTX.
The measured pH of the test medium at the start of the test was 1.50, i.e. within the specifications of pH 1.5 ± 0.1. The pH measured in the additional test item vessel at the beginning of the trial was 1.50 for the 0.2 g/L and 1.51 for the 2 g/L loadings, respectively, i.e. within the specifications of pH 1.5 ± 0.1. At the 2 hours endpoint of the test, the pH in the Negative Control vessel was 1.50 and 1.50 in the Positive Control. The pH in the test item vessels was between 1.52 and 1.53 for the vessels at the 0.2 g/L loadings and between 1.57 and 1.59 for the vessels at the 2 g/L loadings.
The temperature of the sampled test solutions, including the Negative and Positive Control vessel, was between 36.9 °C and 37.1 °C and corresponded to the required test conditions of 37 °C ± 1 °C.
The Negative Control vessel showed no concentrations of lithium, manganese and nickel above the respectively limit of quantification (i.e. accredited reporting limit) of 0.5 μg/L Li, 2 μg/L Mn and 0.5 μg/L Ni.
In the test item vessels with a loading of 0.2 g/L LNMO, the following average dissolved element concentrations of:
- • 0.510 ± 0.006 mg/L Li (CVbetween-vessel = 1 %; N = 3) or 2.55 ± 0.03 mg/g test item,
- • 1.45 ± 0.02 mg/L Mn (CVbetween-vessel = 1 %; N = 3) or 7.22 ± 0.08 mg/g test item,
- • 0.366 ± 0.010 mg/L Ni (CVbetween-vessel = 3 %; N = 3) or 1.83 ± 0.05 mg/g test item,
was measured after 2 hours of exposure to the simulated gastric fluid (pH 1.5).
Based on the specific surface area of LNMO (i.e. 0.2 m²/g), this corresponds to an element release per surface of:
- • 13 mg/m² lithium,
- • 36 mg/m² manganese,
- • 9.1 mg/m² nickel.
Based on the element contents (i.e. 3.87 % Li, 44.7 % Mn and 14.9 % Ni) in the test item and the average dissolved element concentrations in the test solutions, a release of:
- • lithium of 6.6 % of the content,
- • manganese of 1.6 % of the content,
- • nickel of 1.2 % of the content,
could be calculated at the 2 hours endpoint.
In the test item vessels with a loading of 2 g/L LNMO, the following average dissolved element concentration of:
- • 5.44 ± 0.09 mg/L Li (CVbetween-vessel = 2 %; N = 3) or 2.72 ± 0.05 mg/g test item,
- • 14.1 ± 0.5 mg/L Mn (CVbetween-vessel = 3 %; N = 3) or 7.03 ± 0.24 mg/g test item,
- • 3.64 ± 0.03 mg/L Ni (CVbetween-vessel = 1 %; N = 3) or 1.82 ± 0.02 mg/g test item,
was measured after 2 hours of exposure to the simulated gastric fluid (pH 1.5).
Based on the specific surface area of LNMO (i.e. 0.2 m²/g), this corresponds to an element release per surface of:
- • 14 mg/m² lithium,
- • 35 mg/m² manganese,
- • 9.1 mg/m² nickel.
Based on the element contents (i.e. 3.87 % Li, 44.7 % Mn and 14.9 % Ni) in the test item and the average dissolved element concentrations in the test solutions, a release of:
- • lithium of 7.0 % of the content,
- • manganese of 1.6 % of the content,
- • nickel of 1.2 % of the content,
could be calculated at the 2 hours endpoint.
The results of this study can be used as a tool to correct the hazard classification, establish categories for grouping, or justify test waivers.
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.