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Diss Factsheets
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EC number: 700-042-6 | CAS number: 177997-13-6
- 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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Nickel
- EC Number:
- 231-111-4
- EC Name:
- Nickel
- Cas Number:
- 7440-02-0
- Molecular formula:
- Ni
- IUPAC Name:
- nickel
- Reference substance name:
- Cobalt
- EC Number:
- 231-158-0
- EC Name:
- Cobalt
- Cas Number:
- 7440-48-4
- Molecular formula:
- Co
- IUPAC Name:
- cobalt(2+)
- Reference substance name:
- Lithium
- EC Number:
- 231-102-5
- EC Name:
- Lithium
- Cas Number:
- 7439-93-2
- Molecular formula:
- Li
- IUPAC Name:
- lithium
- Reference substance name:
- Aluminium
- EC Number:
- 231-072-3
- EC Name:
- Aluminium
- Cas Number:
- 7429-90-5
- Molecular formula:
- Al
- IUPAC Name:
- aluminum
- Test material form:
- solid: particulate/powder
- Details on test material:
- Composition represents the lowest and highest possible concentration of each individual constituent in NCA (estimated by Monte Carlo simulation, taking into account the following ranges of variability:
Sum of of Ni+Co+Al = approx. 1
Li =0.9-1.3
Ni: 0.75-0.99
Co: 0.01-0.2
Al: 0.01-0.2
A more detailed composition can be provided by the data holder, but is not defined in this record as this represents sensitive business information that cannot be shared with co-registrants. The composition, however, fits into the agrees Substance Identity Profile.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Oxon, UK
- Age at study initiation: 8 to 11 weeks
- Weight at study initiation: 199 to 350 g
- Fasting period before study: no
- Housing: groups of 5 of the same sex
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C,
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- In order to facilitate aerosolization and reduce particle size, the test itern was ground using a srnall arnount of Diethyl Ether in a Retsch Planetary Ball Mill (Retsch (UK) Ltd, Leeds, UK) the solvent was rernoved via evaporation prior to use. The absorption of the test itern was not
deterrnined. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 0.05, 0.23, 1.02 and 2.08 mg/L
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- On the day of exposure (Groups 1 and 3) or prior to the day of exposure (Groups 2 and 4) each rat was acclimatized (for approximately 2 hours) to a tapered polycarbonate restraining tube. During each exposure period, each rat was individually held in a tapered, polycarbonate restraining tube fitted onto a single tier of the exposure chamber and sealed by means of a rubber 'O' ring. Only the nose of each animal was exposed to the test atmosphere. Following an appropriate equilibration period four groups, each of ten rats (five males and five females), were subjected to a single exposure to the test item for a period of four hours. Based on the expected toxicity of the test item, a target concentration of 2.0 mg/L was used for the first exposure. Further concentrations were selected after consideration of the results of the previous exposure.
Clinical Signs:
All animals were observed for clinical signs at hourly intervals during exposure, immediately on removal from the restraining tubes at the end of exposure, one hour after termination of exposure and subsequently once daily for up to fourteen days. Any deaths or evidence of overt toxicity were recorded at each observation.
Body Weight:
Individual body weights were recorded on arrival, prior to treatment on the day of exposure and on Days 1, 3, 7 and 14 or at death.
Necropsy:
At the end of each fourteen day observation period, the surv1vmg animals were killed by intravenous overdose of sodium pentobarbitone. All animals, including those that died during the study were subjected to a füll external and internal examination, and any macroscopic abnormalities were recorded. The respiratory tract was subjected to a detailed macroscopic examination for signs of irritancy or local toxicity. - Statistics:
- No statistical analysis was performed.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- 0.05 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 0.15 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- see "Any other information on results incl. tables"
- Clinical signs:
- other: Common abnormalities noted during the study included increased respiratory rate, hunched posture, pilo-erection, generalized black für staining caused by the test item and wet für. There were occasional instances of ataxia and isolated occurrences of tip-
- Body weight:
- Group 1 - All animals exhibited body weight losses or showed no body weight gain on the first day post-exposure.
Group 2 - All animals exhibited body weight losses on the first day post-exposure.
Group 3 - All animals exhibited body weight losses or showed no body weight gain on the first day post-exposure. The surviving male animal exhibited fürther body weight losses during the first week of the recovery period but then showed body weight gain during the final week of the recovery period.
Group 4 - Two males and two female animals exhibited body weight losses or showed no body weight gains on Day 1 post-exposure. One male showed no body weight gain from Days 1 to 3 post-exposure, whereas four female animals exhibited body weight losses during the same time period. Body weight gains were noted in all animals during the remainder of the recovery period. - Gross pathology:
- Dark patches on the lungs were noted in the surviving animal from Group 3. Seven out of 10 surviving animals from Group 4 exhibited abnormally dark lungs or dark patches on the lungs at necropsy.
The following macroscopic abnormalities were detected at necropsy amongst animals that died or were humanely killed during the course ofthe study: Lungs - abnormally dark; Liver- dark, accentuated lobular pattem; Small Intestine - gaseous distension, hemorrhagic.
Due to the observations noted during the study and at necropsy it is considered that deaths noted during the study may have been mainly attributable to systemic toxicity.
Any other information on results incl. tables
Mortility data:
Deaths | ||||
Group number | Mean achieved atmosphere concentration (mg/L) | Male | Female | Total |
1 | 2.08 | 5/5 | 5/5 | 10/10 |
2 | 1.02 | 5/5 | 5/5 | 10/10 |
3 | 0.23 | 4/5 | 5/5 | 9/10 |
4 | 0.05 | 0/5 | 0/5 | 0/10 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 based on GHS criteria
- Conclusions:
- No mortality was observed at 0.05 mg/L which is the upper threshold value for Cat.1-classification.
A Cat.2 classification is allocated for substances with an LC50 between 0.05 and 0.5 mg/L. 90% mortality was observed at a concentration of 0.23 mg/L,
Based on these observations (no mortality at the lower Cat.2 threshold, ca.100% mortality at the upper Cat.2 threshold), a Cat.2 classification for acute inhalation toxicity is applicable for this substance
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