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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 June 2007 to 3 July 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 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
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
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Strain: 16 CBA/Ca (CBA/CaBkl) mice; 1 CBA/Ca (CBA/Ca CruBR) mouse
- Age at study initiation: 8 - 12 weeks old
- Weight at study initiation: 15 - 23 g
- Housing: individually in suspended solid-floor polypropylene cages furnished with softwood woodflakes
- Diet: ad libitum Certified Rat and Mouse Diet
- Water: ad libitum access to mains tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 – 25 °C
- Humidity (%): 30 – 70 % (relative)
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light (06:00 to 18:00)
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- - Preliminary Screening Test
50 % w/w in vehicle
- Main Test
0, 10, 25 and 50 % w/w in vehicle - No. of animals per dose:
- - Preliminary Screening Test
1 female
- Main Test
4 females per dose - Details on study design:
- PRELIMINARY SCREENING TEST
A single mouse was treated by daily application of 25 µL of test material at a concentration of 50 % w/w in vehicle, to the dorsal surface of each ear for three consecutive days (days 1, 2 and 3). The mouse was observed twice daily on days 1, 2 and 3 and once daily on days 4, 5 and 6. Any signs of toxicity or excessive local irritation noted during this period were recorded. Body weight measurements were taken on day 1 (prior to dosing) and on day 6.
Based on findings from the preliminary screening test, the dose levels selected for the main test were 10, 25 and 50 % w/w in vehicle.
MAIN STUDY
The mice were treated by daily application of 25 µL of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (days 1, 2 and 3). The test material formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette. A further group of 4 animals received the vehicle alone in the same manner.
³H-Methyl Thymidine Administration
Five days following the first topical application of the test material (day 6) all mice were injected via the tail vein with 250 µL of phosphate buffered saline (PBS) containing ³H-methyl thymidine (³HTdR: 80 µCi/mL, specific activity 2.0 Ci/mmol) giving a total of 20 µCi to each mouse.
OBSERVATIONS
- Clinical observations: all animals were observed twice daily on days 1, 2 and 3 and once daily on days 4, 5 and 6. Any signs of toxicity or signs of ill health were recorded.
- Body weights: body weight measurements were recorded on day 1 (prior to dosing) and on day 6 (prior to termination).
TERMINAL PROCEDURES
5 hours following administration of ³HTdR all mice were sacrificed by carbon dioxide asphyxiation. The draining of the auricular lymph nodes from the four mice of each group were excised and pooled and 1 mL of PBS added.
A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation through a 200-mesh stainless steel gauze. The lymph node cells were rinsed through the gauze with 4 mL of PBS into a petri dish. The lymph node cell suspension was transferred to a centrifuge tube. The petri dish was washed with an additional 5 mL of PBS to remove all remaining lymph node cells and these were added to the centrifuge tube. The pooled lymph node cells were pelleted at 1400 rpm (approximately 190 x gravity) for ten minutes. The pellet was re-suspended in 10 mL of PBS and re-pelleted. To precipitate out the radioactive material, the pellet was re-suspended in 3 mL of 5 % trichloroacetic acid (TCA).
After incubation for approximately 18 hours at approximately 4 °C, the precipitates were recovered by centrifugation at 2100 rpm (approximately 450 x gravity) for 10 minutes, re-suspended in 1 mL of TCA and transferred to 10 mL of scintillation fluid (Optiphase Trisafe). ³HTdR incorporation was measured by β-scintillation counting. The Poly Q vials containing the samples and scintillation fluid were placed in the sample changer of the scintillator and left for approximately twenty minutes to reduce the risk of luminescence. After 20 minutes the vials were shaken vigorously. The number of radioactive disintegrations per minute was then measure using the Beckman LS6500 scintillation system.
INTERPRETATION OF RESULTS
The proliferation of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node (disintegrations per minute/node) and as the ration of ³HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index).
A test material will be regarded as a skin sensitiser if at least one concentration of the test material results in a threefold or greater increase in ³HTdR incorporation compared to controls. - Positive control substance(s):
- other: phenylacetaldehyde (90 %)
Results and discussion
- Positive control results:
- A study was performed to assess the sensitivity of the strain of mouse used at the test laboratory to a known sensitiser. The study was conducted under GLP conditions and in accordance with the standardised guidelines OECD 429 and EU Method B.42.
During the study, 3 groups of 5 animals were treated with 50 µL (25 µL per ear) of2-phenylacetaldehyde (90 %) as a solution in propylene glycol at concentrations of 5, 10 and 25 % v/v. A further group was treated with vehicle alone.
The stimulation index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control groups was 11.25, 20.00 and 29.49 at positive control concentrations of 5, 10 and 25 % v/v, respectively. Phenylacetaldehyde (90 %) was therefore confirmed to be a skin sensitiser under the conditions of the test.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.32
- Remarks on result:
- other: Concentration (% w/w) in propylene glycol: 10
- Key result
- Parameter:
- SI
- Value:
- 1.25
- Remarks on result:
- other: Concentration (% w/w) in propylene glycol: 25
- Key result
- Parameter:
- SI
- Remarks on result:
- other: A stimulation index of less than 3 was recorded for the three concentrations of test material that were tested (see Table 1).
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 3846.51, 5092.86, 4793.05 and 5104.41 disintegrations per minute were recorded for the vehicle and test material concentrations of 10, 25 and 50 % w/w in vehicle, respectively (see Table 1).
- Parameter:
- SI
- Value:
- 1.33
- Remarks on result:
- other: Concentration (% w/w) in propylene glycol: 50
Any other information on results incl. tables
Preliminary Screening Test
No signs of toxicity were noted. Black staining on the ears and fur was noted post-dose on days 1, 2 and 3.
Main Test
There were no deaths. No sign of systemic toxicity were noted in the test or control animals during the test. Black staining on the ears and fur was noted in animals treated with the test material at a concentration of 50 % w/w in propylene glycol post-dose on days 1, 2 and 3, and in all test animals on day 4. Body weight changes of the test animals between day 1 and day 6 were comparable to those observed in the corresponding control group animals over the same period.
Table 1: Results from the Main Test
Conc. (% w/w) in vehicle |
dpm |
dpm/node* |
Stimulation Index# |
Result |
0 (vehicle control) |
3846.51 |
480.81 |
na |
na |
10 |
5092.86 |
636.61 |
1.32 |
Negative |
25 |
4793.05 |
599.13 |
1.25 |
Negative |
50 |
5104.41 |
638.05 |
1.33 |
Negative |
dpm: disintegrations per minute
* disintegrations per minute/node obtained by dividing the disintegrations per minute value by 8 (total number of lymph nodes)
# stimulation index of 3.0 or greater indicates a positive result
na: not applicable
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was considered to be a non-sensitiser under the conditions of the test.
- Executive summary:
The skin sensitisation potential of the test material was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 429 and EU Method B.42.
Following a preliminary screening test, three groups, each of four animals, were treated with 50 µL (25 µL per ear) of the test material as a suspension in propylene glycol at concentrations of 10, 25 and 50 % w/w. A further group of four animals was treated with propylene glycol alone.
The stimulation index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group was 1.32, 1.25 and 1.33 for test material concentrations of 10, 25 and 50 % w/w in vehicle, respectively.
The test material was therefore considered to be a non-sensitiser under the conditions of the test.
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