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Diss Factsheets
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EC number: 224-699-9 | CAS number: 4454-16-4
- 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
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Epidemiological data
Administrative data
- Endpoint:
- epidemiological data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- not reported
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Meets generally accepted scientific standards, well documented and acceptable for assessment. Relevant exposure to submission substance, adequate information on study cohort and exposure, relevant endpoint (A detailed description of the scoring criteria can be found in the .pdf document attached to the 'Epidemiological Data Scoring Rationale Document' record at the beginning of Section 7.10.2).
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:
- Exposure to different forms of nickel and risk of lung cancer.
- Author:
- Grimsrud TK, Berge SR, Haldorsen T, Andersen A.
- Year:
- 2 002
- Bibliographic source:
- Am. J. Epidemiol., 156, 1123-1132.
Materials and methods
- Study type:
- case control study (retrospective)
- Endpoint addressed:
- carcinogenicity
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No standard guideline reported. Study details provided in the following sections
- GLP compliance:
- not specified
Test material
Method
- Type of population:
- occupational
- Ethical approval:
- not applicable
- Details on study design:
- HYPOTHESIS TESTED: The aim of the present study was to explore the dose-related association between cumulative exposure to nickel and lung
cancer, with optimal adjustment for smoking, according to the four forms of nickel conventionally addressed: water-soluble,
sulfidic, oxidic, and metallic. Another aim was to evaluate the effect of joint exposure to nickel and tobacco smoking.
METHOD OF DATA COLLECTION
- Type: Record review / Work history
- Details: information obtained from company records, questionnaires, and The Cancer Registry of Norway
STUDY PERIOD: employment during the period of 1910 - 1994 and under observation for cancer between 1952-1995.
SETTING: evaluated men who had been employed in the nickel refinery in Kristiansand, Norway
STUDY POPULATION
- Total population (Total no. of persons in cohort from which the subjects were drawn): 5389
- Selection criteria: employment for a minimum of 12 months
- Total number of subjects participating in study: 213
- Sex/age/race: men
- Smoker/nonsmoker: smoking history was examined
- Total number of subjects at end of study: 213
- Matching criteria: none reported
- Other: none
COMPARISON POPULATION
- Type: Control or reference group
- Details: n= 525, controls were free of lung cancer and had been born within 24 months from the case’s date of birth.
HEALTH EFFECTS STUDIED
- Disease(s): lung cancer
- ICD No.: not reported
- Year of ICD revision: not reported
- Diagnostic procedure: not reported
- Other health effects: not reported
OTHER DESCRIPTIVE INFORMATION ABOUT STUDY: none - Exposure assessment:
- measured
- Details on exposure:
- TYPE OF EXPOSURE: inhalation of nickel refinery dusts and aerosols
TYPE OF EXPOSURE MEASUREMENT: Personal sampling, nickel speciation performed with sequential extractions (Zatka et al. 1992)
EXPOSURE LEVELS: See table below
EXPOSURE PERIOD: minimum of 12 months
POSTEXPOSURE PERIOD: 10 to 20 year lag
DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES: evaluated by nickel species: water soluble, oxidic, sulfidic, or metallic Ni - Statistical methods:
- Relative risks were estimated as odds ratios and 95 percent confidence intervals derived from conditional logistic regression models.
Results and discussion
- Results:
- EXPOSURE: mean cumulative exposure (mg/m3) x years of refinery workers for cases
Water soluble Ni: 2.45
Sulfidic Ni: 0.63
Oxidic Ni: 4.34
Metallic Ni: 0.92
Other exposures included: As, asbestos, mists containing sulfuric acid. Some workers were exposed to carcinogens outside the refinery. . [Exposure matrix reported in Grimsrud et al., 2000]
FINDINGS: A clear dose-related effect was seen for water-soluble nickel (odds ratio = 1.7) and lung cancer
INCIDENCE / CASES
- Number of cases for lung cancer: 213 workers, 525 controls
STATISTICAL RESULTS
- OR (Odds ratio): smoking adjusted by Ni species, high exposure
Water soluble Ni (4.93 mg/m3 x years) = 3.8
Sulfidic Ni (1.43 mg/m3 x years) = 2.8
Oxidic Ni (12.6 mg/m3 x years) = 2.2
Metallic Ni (2.32 mg/m3 x years) = 2.4
- OR (Odds ratio): for water-soluble Ni, smoking adjusted, 10-year lag = 1.7 (95% CI = 1.2-2.3)
OTHER OBSERVATIONS: The exposures to various forms of nickel were all correlated. Exposures to water-soluble nickel and metallic nickel and exposures to oxifdic and sulfidic nickel were highly correlated (r = 0.71 and 0.87, respectively). It was not possible to distinguish between the effect from metallic nickel and other forms of insoluble nickel. The exposure levels of the Cases were similar to the Controls for sulfidc and oxidic nickel but were 50% and 30% higher than Controls for soluble and metallic nickel, respectively. - Confounding factors:
- effects of smoking were addressed
- Strengths and weaknesses:
- Strengths: Examined Ni species.
Weaknesses: There was low to moderate confounding from smoking.
Applicant's summary and conclusion
- Conclusions:
- A clear dose-related effect was seen for water-soluble nickel (odds ratio = 1.7) and lung cancer.
- Executive summary:
STUDY RATED BY AN INDEPENDENT REVIEWER.
(A detailed description of the scoring criteria can be found in the .pdf document attached to the 'Epidemiological Data Scoring Rationale Document' record at the beginning of Section 7.10.2).
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.
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