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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 480-390-0 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 June 2007 to 28 June 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to valid guidelines and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 480-390-0
- EC Name:
- -
- Cas Number:
- 182442-95-1
- Molecular formula:
- LiCoNiMnO2 with the stoechiometry of Co+Ni+Mn equal to 1 and the ranges of the elements approximately as: Li: >0.90 - <1.20 Co: >0.0 - <0.50 Ni: >0.20 - <0.98 Mn: >0.0 - <0.50 O: 2
- IUPAC Name:
- Cobalt Lithium Manganese Nickel Oxide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Cellcore MX
- Physical state: solid
- Appearance: black powder
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12 - 20 weeks old
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: individually in suspended cages
- Diet: ad libitum Certified Rabbit Diet
- Water: ad libitum access to mains drinking water
- Acclimation period: at least 5 days
Immediately before the start of the test, both eyes of the rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 – 23 °C
- Humidity (%): 30 – 70 % (relative)
- Air changes (per hr): at least 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light (06:00 to 18:00)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye of each animal remained untreated and served as the control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 mL of test material (weighing 100 mg)
Owing to the high pH of the test material (pH 11.0), and in order to minimise the pain on application of the test material, one drop of local anaesthetic (Tetracaine hydrochloride 0.5 %) was instilled into both eyes of the treated animals 1 to 2 minutes before treatment. - Duration of treatment / exposure:
- Test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower lids were held together for about one second immediately after treatment, and then released.
- Observation period (in vivo):
- Assessment of ocular damage/irritation was made approximately 1, 24, 48 and 72 hours following treatment.
Initially a single animal was treated. After consideration of the ocular response produced in the first treated animal, two additional animals were treated. - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM:
- Immediately after administration of the test material, an assessment of the initial pain reaction was made according to the six point scale (see below).
- Assessment of ocular reaction at 1, 24, 48 and 72 hours was made according to the Draize scale (see below).
- Any other ocular effects were also noted
TOOL USED TO ASSESS SCORE:
Examination of the eye was facilitated by the use of a light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of all three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- of all three animals
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- - No corneal effects were noted.
- Iridial inflammation was noted in one treated eye one hour after treatment.
- Minimal to moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted in all treated eyes at the 24-hour observation.
- All treated eyes appeared normal at the 48-hour observation. - Other effects:
- Black staining on the fur was noted around all treated eyes throughout the study.
Any other information on results incl. tables
Table 1: Individual Scores for Ocular Irritation
Rabbit |
1M (IPR = 2) |
2M (IPR = 1) |
3M (IPR = 0) |
|||||||||
Time after treatment (hrs) |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
CORNEA |
|
|||||||||||
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IRIS |
|
|||||||||||
Score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
CONJUNCTIVAE |
|
|
|
|
|
|
|
|
|
|
|
|
Redness |
1 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
Chemosis |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
Discharge |
1Sf |
0Sf |
0Sf |
0Sf |
1Sf |
0Sf |
0Sf |
0Sf |
1Sf |
0Sf |
0Sf |
0Sf |
IPR = initial pain reaction
Sf = black staining of the fur around the treated eye
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, the test material induced only minimal reversible irritation to the eye in the New Zealand White rabbit. The test material was therefore considered to be not irritating in accordance with EU criteria.
- Executive summary:
The eye irritancy potential of the test material was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 405 and EU Method B.5.
0.05 mL of test material (weighing 100 mg) was installed into the right eye of the New Zealand White rabbits. Assessment of ocular damage/irritation was made approximately 1, 24, 48 and 72 hours following treatment. Initially a single animal was treated. After consideration of the ocular response produced in the first treated animal, two additional animals were treated.
The application of the test material to the non-irrigated eye of three rabbits produced iridial inflammation in one eye, and minimal to moderate conjunctival irritation in all treated eyes, one hour after treatment. All treated eyes appeared normal at the 48-hour observation.
Under the conditions of the study, the test material induced only minimal reversible irritation to the eye in the New Zealand White rabbit. The test material was therefore considered to be not irritating in accordance with EU criteria.
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.