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EC number: - | CAS number: -
- 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:
- Study completed March 20, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- 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.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Lithium nickel potassium oxide
- Cas Number:
- 210352-95-7
- Molecular formula:
- Li.K.Ni.O.H2O
- IUPAC Name:
- Lithium nickel potassium oxide
- Test material form:
- solid: particulate/powder
- Details on test material:
- Lithium nickel potassium oxide (KDLNO)
CAS Number:
210352-95-7
Appearance/Physical state:
Black powder
Storage: Room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Rats were selected since this rodent species is recommended in the respective test guidelines. Wistar rats were selected since there is extensive experience available in the laboratory with this strain of rats.
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Nulliparous and non-pregnant female animals were used for the test as suggested by the OECD guideline when there is no indication that male animals are likely to be more sensitive to the acute effects of the test item. They were young adult animals (female animals approx. 10 weeks and of comparable weight (± 20% of the mean weight)). There was an acclimatization period of at least 5 days before the beginning of the experimental phase; during the acclimatization period, the animals were accustomed to the environmental conditions of the study and to the diet. Rats were identified by individual identification by cage cards and tail marking.
The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 22°C ± 3°C for temperature and of 30 – 70% for relative humidity. There were no deviations from these ranges, which influenced the results of the study.
Air changes per hour
Approx. 10
Day / night rhythm:
12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)
Type of cage:
Makrolon cage, type III
Number of animals per cage:
Single housing
Feeding:
VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
Drinking water:
Tap water ad libitum
Bedding:
H 15005-29; Ssniff, Spezialdiäten GmbH (Experimental Animal Diets Inc., 59494 Soest, Germany)
Enrichment:
Wooden gnawing blocks (Type NGM E-022); ABEDD® LAB & VET Service GmbH, Hasnerstraße 84/6; 1160 Wien – Austria
The feed used in the study was assayed for chemical and microbial contaminants by the manufacturer in quarterly intervals. Results are archived by Bioassay.
The drinking water was regularly assayed for contaminants by the municipal authorities of Heidelberg. The German Drinking Water Regulation of Dec. 5, 1990 served as the guideline for maximum tolerable contaminants.
The bedding and enrichment were regularly assayed for contaminants (chlorinated hydrocarbons and heavy metals).
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Remarks:
- Chosen due to good homogeneity of the test material in corn oil
- Details on oral exposure:
- The test item formulation was prepared shortly before application by stirring with a high speed homogenizer (Ultra-Turrax) and a magnetic stirrer. Additionally, the homogeneity of the test item preparation during application was ensured by stirring with a magnetic stirrer. The stability of the test item in the vehicle was determined indirectly by concentration control analysis. For this purpose, the samples taken were stored at room temperature over the maximum duration of the administration period, subsequently deep-frozen and sent for analysis.
The homogeneity of the test item preparation was determined indirectly by concentration control analysis.
Route of administration:
Single oral administration by gavage.
Fasting period:
Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
Time of day of administration:
In the morning
Observation period:
14 days
Body weight determination:
Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation and on the day of death starting with study day 1. - Doses:
- SELECTION OF DOSES/CONCENTRATIONS
A starting dose of 2000 mg/kg bw was chosen in the first step with 3 female animals.
As all animals died, a dose of 500 mg/kg bw was administered to 3 female rats in the second step.
Because no mortality occurred, a further dose of 500 mg/kg bw was administered to another group of 3 female animals in the third step. - No. of animals per sex per dose:
- 3 females per dose
- Control animals:
- no
- Details on study design:
- The objective of this study was to assess the acute oral median lethal dose following a single oral administration to female Wistar rats followed by a 14 day observation period.
The study was performed in rats, because this species has been shown to be suitable for this type of study and is recommended by the test guidelines. - Statistics:
- In the single 2000 mg/kg bw test group all animals died on day 3 or 5 after administration.
No mortality occurred in both 500 mg/kg bw test groups.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 500 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- In the single 2000 mg/kg bw test group all animals died on day 3 or 5 after administration.
No mortality occurred in both 500 mg/kg bw test groups. - Clinical signs:
- other: Clinical signs in the single 2000 mg/kg test group revealed in all animals an impaired general state and piloerection from hour 2 or 4 until hour 5 and again from day 2 until day 3 after administration. Black discolored faeces was seen on day 1 in all ani
- Gross pathology:
- The following macroscopic pathologic findings were observed in the animals that died (single 2000 mg/kg bw test group, 3 females):
o Stomach filled with blackish liquid, discoloration of the stomach contents
o Dark discolored small and large intestine
There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period (6 females of both 500 mg/kg bw. groups). - Other findings:
- The following test substance-related clinical observations were recorded, clinical signs occurred within the first 5 days after administration:
2000 mg/kg (single test group):
Mortality in all animals
Impaired general state in all animals
Dyspnea in all animals
Piloerection in all animals
Black discolored faeces in all animals
Reduced defecation in all animals
Exsiccosis in all animals
Macroscopic pathological findings in the animals that died:
o Filled stomach with blackish liquid, discoloration of the stomach contents
o Dark discolored small and large intestine
500 mg/kg (both test groups):
No clinical signs were observed
The body weights of the surviving animals in both 500 mg/kg bw test groups increased within the normal range throughout the study period.
There were no macroscopic pathological findings in any animal sacrificed at the end of observation period (6 females of both 500 mg/kg bw test groups).
The acute oral LD50 was calculated to be
LD50, oral, rat > 500 < 2000 mg/kg bw
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under the conditions of this study the median lethal dose of KDLNO after oral administration was found to be greater than 500 mg/kg bw and less than 2000 mg/kg bw in rats.
- Executive summary:
In an acute oral toxicity study performed according to the Acute Toxic Class Method, doses of 2000 and 500 mg/kg bw of the test item KDLNO (preparations in corn oil Ph.Eur.) were administered by gavage to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 3 females, 500 mg/kg bw in 6 females).
Under the conditions of this study the median lethal dose of KDLNO after oral administration was found to be greater than 500 mg/kg bw and less than 2000 mg/kg bw in rats. The acute oral LD50 was calculated to be LD50, oral, rat > 500 < 2000 mg/kg bw
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