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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 234-454-8 | CAS number: 12004-35-2
- 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
Epidemiological data
Administrative data
- Endpoint:
- epidemiological data
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1978-1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study had medium relevance to the Hazard or Risk Assessment of NiO, medium quality of cohort definition and size, medium quality of exposure data and a medium quality of endpoint results and reporting. A detailed description of the scoring criteria and results can be found attached to IUCLID Section 7.10.2-Epidemiological Data, Epidemiological Data Summary and Scoring.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Determination of nickel in lung specimens of thirty-nine autopsied nickel workers
- Author:
- Andersen I, Svenes KB
- Year:
- 1 989
- Bibliographic source:
- Int Arch Occup Environ Health 61:289-295
Materials and methods
- Study type:
- case control study (retrospective)
- Endpoint addressed:
- carcinogenicity
- Principles of method if other than guideline:
- Lung specimens from 39 nickel refinery workers who were autopsied during the period of 1978 to
1984 were analyzed for nickel levels and evalauted relative to lung cancer diagnoses - GLP compliance:
- not specified
Test material
- Reference substance name:
- Nickel monoxide
- EC Number:
- 215-215-7
- EC Name:
- Nickel monoxide
- Cas Number:
- 1313-99-1
- IUPAC Name:
- oxonickel
- Details on test material:
- - Name of test material (as cited in study report): nickel-copper oxide, (Ni, CU)O
Constituent 1
Method
- Type of population:
- occupational
- Ethical approval:
- not specified
- Details on study design:
- METHOD OF DATA COLLECTION
- Type: Interview / Questionnaire / Record review / Work history / Clinical tests / other: lung specimens, Employment records, medical files
- Details: lung specimens collected from 39 consecutive autopsies between 1978 and 1984. Control lung tissue was also obtained from 16 autopsied persons not connected with the refinery. Tissue was collected from the right lower lobe and place in formaldehyde with Na2HPO4. Medical files were used to determine cause and age of death as well as smoking information.
-Other: specimens from the center and periphery of each lobe were collected from a worker (not included in the 39) and analyzed to determine variations in nickel concentration in different regions of the lung.
STUDY PERIOD: workers autopsied between 1978 and 1984
SETTING: Nickel refinery in Kristiansand, Norway
STUDY POPULATION
- Total population (Total no. of persons in cohort from which the subjects were drawn): 39 workers, 16 controls
- Selection criteria: nickel refinery worker
- Total number of subjects participating in study: 39
- Sex/age/race: average age of death was 66+/- 8 years; for workers with carcinomas 64 +/- 8.
- Smoker/nonsmoker: 23 cigarette smokers, 11 other smokers (<10 cigarettes daily, former smokers, pipe smokers), 5 non-smokers
- Other: average age at start of employment for all workers was 39 +/- 11 years, for those with carcinomas of the lung 38 +/- 8 years
COMPARISON POPULATION
- Type: State registry / Regional registry / National registry / Control or reference group / Other comparison group: other
- Details: autopsied persons non connected with the refinery
HEALTH EFFECTS STUDIED
- Disease(s): lung cancer
- Other health effects: other causes of death reported but not statistically evaluated included nose, colon, kidney and malignant melanoma cancers
OTHER DESCRIPTIVE INFORMATION ABOUT STUDY:
-lung samples were analyzed for total nickel using Electrothermal Atomic Absorption Spectrometery - Exposure assessment:
- not specified
- Details on exposure:
- DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES:TYPE OF EXPOSURE:
-15 workers were employed in the Roasting and Smelting Department where exposure to nickel was predominantly in the form of nickel-copper oxides, Ni3S2 and metallic dust
- 24 workers were employed in the Electrolysis Department where exposure was considered to be mostly to the water-soluble compounds, NiS04 and NiCl2, but also to a lesser degree to water-insoluble nickel compounds such as nickel-copper oxides and sulphides - Statistical methods:
- Means of lung nickel concentrations were tested to see if levels differed at the 1% (P=O.Ol) or 5% (P =0.05) level of significance employing a one-way analysis of variance (the F-statistic). Sampled populations were also tested against each other with Duncan's New Multiple Range Test with unequal observations. To meet the conditions of normal distributions and comparable population variances, all statistical comparisons involved logarithms of the nickel concentrations.
Results and discussion
- Results:
- EXPOSURE (Lung tissue measurements)
Roast and Smelting Department (n=15)
-Arithmetic mean ± SD: 333 ± 382 µg/g dry weight
-Geometric mean: 148 µg/g dry weight with 99% CLs of 45-490 µg/g dry weight
Electrolysis Department (n=24)
-Arithmetic mean ± SD: 34 ± 48 µg/g dry weight
-Geometric mean: 16 µg/g dry weight, with 99% CLs of 8-34 microgram per gram dry weight
Reference Group (n=16)
-Arithmetic mean ± SD: 0.76 ± 0.39 µg/g dry weight
Geometric mean: 0.67 µg/g dry weight, with 99% CLs of 0.48-0.95 µg/g dry weight
INCIDENCE / CASES OF LUNG CANCER
-Roasting and Smelting Department: lung cancer present in 8 of 24 workers; F-statistic = 0.50 (not significant)
-Electrolysis Department: lung cancer present in 6 of 15 workers; F-statistic = 0.11 (not significant)
-All Workers: lung cancer present in 14 of 39 workers; F-statistic = 0.66 (not significant)
OTHER OBSERVATIONS:
-No trend observed between lung nickel content in relation to the time elapsed between retirement and death
-Lung nickel concentrations did not show any dependence on smoking habits
-One-way ANOVA showed that mean nickel concentrations in lung tissue were statistically significantly different between the three groups. - Confounding factors:
- -Lung nickel concentrations did not show any dependence on smoking habits
- Strengths and weaknesses:
The authors discussed the potential losses of nickel from the tissues during the storage in 4% formaldehyde and the washing protocol (dipping into deionized water), but concluded that good agreement between this study and a previous study was an indication that the loss to the storage medium is minimal.
Any other information on results incl. tables
Applicant's summary and conclusion
- Conclusions:
- The authors concluded that (1) nickel refinery workers exhibit elevated nickel levels in lung tissues at autopsy; (2) workers of the Electrolysis Department and the Roasting and Smelting Department constitute distinct groups with respect to the accumulation of nickel in lung tissue; (3) workers who were diagnosed to have lung cancer had the same lung nickel concentrations at autopsy as those who died of other causes.
The authors also concluded that their data show that pulmonary tissue nickel concentrations may not be used as a definitive etiologic criterion, but that this did not constitute a rejection of a causal relationship between exposure to nickel compounds and respiratory cancers. It was also concluded that in addition to primary exposure to soluble nickel salts, Electrolysis Workers were also exposed to insoluble forms of nickel. - Executive summary:
Andersen and Svenes (1989) reported on the concentrations of nickel in lung tissue collected from refinery workers. The objective of evaluating the concentrations of nickel in the lung specimens was two-fold: (a) measurements would help to clarify the uncertainty in exposure histories to various types of nickel within the refinery, and (b) comparison of tissue concentrations would characterize the levels in workers with and without lung cancer. Lung tissue samples were collected from autopsied workers in the Roasting and Smelting Department (n=15), Electrolysis Department (n = 24), as well as from persons not connected with the refinery (n=16); concentrations of total nickel were determined using Electrothermal Atomic Absorption Spectrometry. Though workplace exposures were not measured in this study, the authors stated that exposure to nickel was predominantly in the form of nickel-copper oxides, Ni3S2, and metallic dust in the Roasting and Smelting Department, whereas in the Electrolysis Department, exposures were to mostly to water soluble compounds (NiSO4 and NiCl2), but also to a lesser degree to water insoluble nickel compounds such as nickel-copper oxides and sulphides. Tissue concentrations were based on samples collected from the right lower lobe; however, additional samples (n=10) collected and analyzed from the center and periphery for each lobe indicated no differences between concentrations in the center and periphery segments.
Results of statistical analyses indicated that measured levels of nickel in the three groups were clearly different; 333 ± 382 μg/g (dry weight), 34 ± 48 μg/g, and 0.76 ± 0.39 μg/g in Roast and Smelting Department workers, Electrolysis Department workers, and the reference group, respectively. When tissue concentrations were compared between individuals diagnosed with lung cancer relative to those diagnosed with other diseases, no significant difference was found. Additionally, no trends between time elapsed between retirement and death, or smoking habits, were found. However, a relationship between the number of years worked and tissue nickel levels was noted. Based on these findings, the authors concluded employment at a nickel refinery resulted in increased tissue levels of nickel in the lung at autopsy, but that these levels did not correlate with the incidence of lung cancer in workers relative to those who died of other causes. Though nickel oxide was only one of many nickel compounds to which workers were exposed, this study clearly indicates that occupational exposure in an environment where nickel-copper oxides were present resulted in higher concentrations of nickel in the lungs relative to environments without such, but that in the study population evaluated, a correlation between lung cancer and tissue concentrations of nickel in the lung was not observed. STUDY RATED BY AN INDEPENDENT REVIEWER
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.