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Toxicological information

Epidemiological data

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Administrative data

Endpoint:
epidemiological data
Type of information:
other: cohort study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Protocol revised by an independent steering committee, study according to the guidelines for reporting observational studies (fullfilling STROBE checklist).
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Investigation of cancer incidence and mortality at a Scottish semiconductor manufactoring facility
Author:
McElvenny, D.M.; A.J. Darnton, J.T. Hodgson, S.D. Clarke, R.C. Elliott
Year:
2003
Bibliographic source:
Occupational Medicine53, 419-430 (2003)

Materials and methods

Study type:
cohort study (retrospective)
Endpoint addressed:
carcinogenicity
Principles of method if other than guideline:
Epidemiological follow-up cohort study.
GLP compliance:
yes
Remarks:
control by an independent Scientific Steering Committee

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Substances present or in use among others at the factory.

Method

Ethical approval:
confirmed and informed consent free of coercion received

Results and discussion

Results:
STATISTICAL RESULTS
There was a statistically significant deficit in male mortality, adjusted SMR (Standard mortality ratio): 40 [95% confidence interval (CI) = 27–59, 27 cases]
There was also a slight deficit of female mortality, adjusted SMR = 75 (95% CI = 54–101, 44 cases)
Total cancer registrations were close to expected levels for men and woman.
Four cancers produced noteworthy findings: malignant neoplasm of the trachea, bronchus and lung in women—deprivation adjusted SRR [95% confidence interval (CI), number of cases] 273 (136–488, 11 cases); malignant neoplasm of the stomach in women—adjusted SRR 438 (90–1281,
three cases); and malignant neoplasm of the female breast—adjusted SRR 134 (82–206, 20 cases). The unadjusted SMR for male brain cancer was 401 (83–1172, three cases) and there was an additional non-fatal case.

Applicant's summary and conclusion

Conclusions:
The findings, particularly those relating to lung cancer, though inconclusive, point to the possibility of a work-related risk of cancer .
The overall mortality was substantially below that expected for men, and slightly below that expected for women.
The total cancer registrations were close to the expected levels for men and women.
Executive summary:

Cohort study with a revised protocol including 4388 workers and a publication of the relevant data.

The overall mortality was substantially below that expected for men, and slightly below that expected for women. The total cancer registrations were close to the expected levels for men and women.