Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
health surveillance data
Type of information:
other: epidemiological study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)

Data source

Materials and methods

Study type:
other: cohort study (retrospective)
Endpoint addressed:
repeated dose toxicity: inhalation
carcinogenicity

Method

Details on study design:
The study was of a cohort design with a comparison of the cancer morbidity and mortality with that of the general population. Complete personnel files were available from about 1955. These files were used to identify a cohort of men with at least five years employment some time between 1955 and 1983. A total of 911 individuals were enrolled; 211 were women, both in administration and production, and of the 700 men, 521 were blue collar workers. All individuals were traced through the official registers and followed up until 31 December 1983 if not dead or emigrated before that date. Seven men had emigrated and eight could not be traced; all were blue collar workers. The loss to follow up was thus about 2% in total or 3% for the blue collar workers.
Information about mortality and cancer morbidity was collected through the National Death Register and the National Cancer Register, respectively. Only the underlying cause of death was considered and a restriction was made by excluding ages above 74 as the diagnostic validity is likely to decrease at higher ages. The observation periods were 1958-83 for mortality and 1958-81 for cancer morbidity, the reason for the difference in the observation period being the lack of cancer incidence data after 1981. Expected incidences were calculated with the person-year method using incidence rates for the general population, stratified for age, calendar year, and gender, for which procedure the EPILIN program was used.

Results and discussion

Any other information on results incl. tables

No significant increase was found in mortality or in cancer morbidity among the blue collar workers.

Among the blue collar workers were four cases of non-malignant respiratory diseases (pneumonia (1), chronic bronchitis (2), and asthma (1)), whereas 3.2 cases of respiratory diseases would have been expected for the general population.

No case of silicosis was found.

Applicant's summary and conclusion