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EC number: 620-400-4 | CAS number: 12031-65-1
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21.Oct.2020 - 19.Feb.2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- December 17, 2001
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- Commission Regulation (EC) No 440/2008 of 30 May 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- December 2002
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nousan No. 8147, November 24, 2000 as this in line with OECD 423.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Incl. GLP certificate from the competent authority
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Lithium; oxido(oxo)nickel
- Cas Number:
- 12031-65-1
- Molecular formula:
- LiNiO2
- IUPAC Name:
- Lithium; oxido(oxo)nickel
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch number of test material: 8800315
- Purity: Approx. 99.8 /100 g
- Water content: 0.1 g/100 g
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Expiry date: August 12, 2021
- Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor
- Homogeneity: The test item was homogeneous by visual inspection.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was prepared and homogenized in corn oil for each test group shortly before administration by stirring with a magnetic stirrer.
- Final concentration of a dissolved solid, stock liquid or gel:
For a dose of 300 mg/kg bw: 6 g/100 ml
For a dose of 2000 mg/kg bw: 40 g/100 ml
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Young adult animals (female animals approx. 10 – 11 weeks)
- Weight at study initiation: Animals were of comparable weight (± 20% of the mean weight; mean group weights on day 0: 198.7 - 193.3 g)
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration
- Housing: Single housing in Makrolon cages, type III. Bedding was H 15005-29; (Ssniff Spezialdiäten GmbH) with wooden gnawing blocks
- Diet: LASQCdiet Rod16, HiHyg, LASvendi (Altromin, Germany) ad libitum
- Water: Tap water ad libitum
- Acclimation period: At least 5 days
- Microbiological status: SPF
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): Approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: At least 5 days before October 27, 2020 To: November 24, 2020
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Remarks:
- Ph.Eur.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Pure corn oil
- Amount of vehicle (if gavage): 5.0 ml/kg bw
- Justification for choice of vehicle: Good homogeneity in corn oil Ph.Eur.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: By request of the sponsor a starting dose of 300 mg/kg bw was chosen in the first step with 3 female animals.
Because no mortality occurred, a further dose of 2000 mg/kg bw was administered to another group of 3 female animals in the second step.
Because no animal died in this step, a further dose of 2000 mg/kg bw was administered to another group of 3 female animals in the third step - Doses:
- 300 mg/kg bw 1. Administration
2000 mg/kg bw 1. Administration
2000 mg/kg bw 2. Administration - No. of animals per sex per dose:
- 3 females
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights were assessed shortly before administration (day 0), weekly thereafter and on the last day of observation. Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter. A check for any dead or moribund animals was made at least once each workday
- Necropsy of survivors performed: yes
- Other examinations performed: Mortality, clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no mortalities in any of the test groups
- Clinical signs:
- other: No clinical signs were observed in any of the test groups
- Gross pathology:
- There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the median lethal dose of the test substance after oral administration was assessed to be greater than 2000 mg/kg bw in rats.
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