Pentanickel octahydroxide carbonate

Epidemiological data

Administrative data

Endpoint:

epidemiological data

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Meets generally accepted scientific standards, well documented and acceptable for assessment. 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-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Occupational exposure to metal compounds and lung cancer. Results from a multi-center case-control study in Central/Eastern Europe and UK

Author:

't Mannetje A, Bencko V, Brennan P, Zaridze D, Szeszenia-Dabrowska N, Rudnai P, Lissowska J, Fabianova E, Cassidy A, Mates D, Foretova L, Janout V, Fevotte J, Fletcher T, Boffetta P

Year:

2011

Bibliographic source:

Cancer Causes Control; 22:1669-1680

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:

Evaluate the risk of lung cancer of subjects previously exposed to 70 suspected occupational carcinogens (including nickel).

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Nickel

EC Number:

231-111-4

EC Name:

Nickel

Cas Number:

7440-02-0

IUPAC Name:

nickel(2+)

Details on test material:

- Name of test material (as cited in study report): Nickel

Method

Type of population:

occupational

Ethical approval:

confirmed, but no further information available

Details on study design:

HYPOTHESIS TESTED (if cohort or case control study):

METHOD OF DATA COLLECTION
- Type: Interview / Questionnaire / Record review / Work history / Clinical tests / other: Interview with questionnaire about lifestyle and occupation

STUDY PERIOD: 1998-2001

SETTING: Central/Eastern Europe and UK

STUDY POPULATION
- Total population (Total no. of persons in cohort from which the subjects were drawn): 2852 cases and 3104 controls
- Selection criteria: subjects were excluded if they had other cancers or tobacco-related diseases
- Total number of subjects participating in study: 5956
- Sex/age/race: males and females aged <75 years
- Smoker/nonsmoker: Not reported
- Matching criteria: sex and age

COMPARISON POPULATION
- Type: State registry / Regional registry / National registry / Control or reference group / Other comparison group: hospital and population controls

HEALTH EFFECTS STUDIED
- Disease(s): lung cancer

Exposure assessment:

measured

Details on exposure:

TYPE OF EXPOSURE: occupational exposure based on historical data

Statistical methods:

Pearson's correlation coefficient
Confidence intervals

Results and discussion

Results:

When no adjustment was made for other occupational exposures, including metals, nickel showed an elevated risk for lung cancer.

When adjusted for other metals, neither nickel dust nor nickel fumes showed a dose-response to occupational nickel exposure. This was likely due to nickel's high correlation with chromium.

For nickel dust, odds ratios(OR) for cumulative exposure were:

low exposure: 0.77 (95% CI: 0.39-1.51)
medium exposure: 1.49 (95% CI: 0.81-2.73)
high exposure: 0.77 (95% CI: 0.38-1.56)

For nickel mist/fumes, odds ratios(OR) for cumulative exposure were:

low exposure: 0.87 (95% CI: 0.49-1.54)
medium exposure: 0.81 (95% CI: 0.44-1.50)
high exposure: 1.16 (95% CI: 0.64-2.08)

Confounding factors:

Smoking, age, sex, occupation, relationship with other metals

Strengths and weaknesses:

Strengths:
-ability to adjust for possible confounders such as smoking and other occupational agents
-ability to study lung cancer risk in relation to exposure levels common to a variety of occupational industries
-large number of study subjects
- use of exposure intensity and frequency, along with exposure duration in cumulative exposure

Weaknesses:
-small number of subjects per country limited country-specific exposure-response
-retrospective nature of study can be an issue for misclassification of exposure; possibly underestimated odds ratio
-methodology is not suitable to assess lung cancer risks of different nickel compounds
-high correlation between nickel and chromium; possible collinearity
-low exposure prevalence in women, so no indication that relative risk to nickel differs between men and women

Any other information on results incl. tables

Not applicable

Applicant's summary and conclusion

Executive summary:

Study was rated by an independent reviewer.