Nickel difluoride

Epidemiological data

Administrative data

Endpoint:

epidemiological data

Type of information:

other: Epidemiological data

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Lung cancer incidence among Norwegian nickel-refinery workers 1953-2000.

Author:

Grimsrud TK, Berge SR, Martinsen JI, Andersen A.

Year:

2003

Bibliographic source:

J. Environ. Monit; 5: 190-197.

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

Test material information

Constituent 1

Reference substance name:

environment nickel

IUPAC Name:

environment nickel

Details on test material:

- Name of test material (as cited in study report): Nickel sulphate
- Molecular formula (if other than submission substance): not different than submission substance
- Molecular weight (if other than submission substance): not different than submission substance
- Smiles notation (if other than submission substance): not different than submission substance
- InChl (if other than submission substance): not different than submission substance
- Structural formula attached as image file (if other than submission substance): not different than submission substance
- Substance type: water-soluble, sulfidic, oxidic and metallic nickel
- Other details on test substance not reported or not applicable

Method

Type of population:

occupational

Ethical approval:

not applicable

Details on study design:

HYPOTHESIS TESTED: The aim of the present study was to assess the effect from time of first employment, length of
employment, work in specific departments, changes in production chemistry and working environment, and nickel exposures.

METHOD OF DATA COLLECTION
- Type: Record review / Work history
- Details: information obtained from company records and The Cancer Registry of Norway

STUDY PERIOD: employment during the period of 1910 - 1989 and under observation for cancer between 1952-2000.

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): 5297
- Selection criteria: employment for a minimum of 12 months
- Total number of subjects participating in study: 5297
- Sex/age/race: men
- Smoker/nonsmoker: smoking history was examined
- Total number of subjects at end of study: 5297
- Matching criteria: none reported
- Other: none

COMPARISON POPULATION
- Type: Control or reference group
- Details: 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:

estimated

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
cumulative exposure / Observed cases / standardised incidence ratios
Total nickel 2.0 mg/m3 x years / 147 / 3.3
Water-soluble ni 2.0 mg/m3 x years / 92 / 4.5

FINDINGS: The results confirmed earlier findings (Grimsrud et al. 2002) of a strong dose-related risk dependent on duration of work in production departments and cumulative exposure to nickel, most clearly seen for water-soluble nickel.

INCIDENCE / CASES / STATISTICAL RESULTS
Duration of employment (years) / observed cases / standardised incidence ratios
1-2.9 years / 59 / 1.9
3-14.9 years / 94 / 2.4
15+ years / 114 / 3.4
Total / 267 / 2.6

Work department / observed cases / standardised incidence ratios
Roasting / 31 / 3.4
Smelting / 58 / 2.7
Copper electrolysis / 39 / 3.5
Nickel electrolysis / 112 / 4.0
Maintenance / 69 / 2.4

Confounding factors:

the effects of smoking were evaluated and determined to not significantly bias the analysis

Strengths and weaknesses:

none reported

Applicant's summary and conclusion

Conclusions:

The results confirmed earlier findings (Grimsrud et al. 2002) of a strong dose-related risk dependent on duration of work in production
departments and cumulative exposure to nickel, most clearly seen for water-soluble nickel.
The study evaluated general nickel exposure. Data can be extrapolated for exposure due to the presence of nickel fluoride

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).