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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Epidemiological data

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Administrative data

Endpoint:
epidemiological data
Type of information:
other: human data
Adequacy of study:
supporting study
Reliability:
other: reliable report, however not rated according to Klimish
Rationale for reliability incl. deficiencies:
other: Well reported cohort study, but no exposure levels available.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Cancer incidence of sulfite pulp workers in Denmark.
Author:
Rix, B.A.; et al.
Year:
1997
Bibliographic source:
Scand. J. Work Environ. Health 23, 458-461

Materials and methods

Study type:
cohort study (retrospective)
Endpoint addressed:
carcinogenicity
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
A retrospective cohort study of cancer risk in the Danish sulphite pulp industry was conducted. Cancer incidence was evaluated for 2 Danish sulphite mills. 2238 persons (only 102 women) employed in 1955-1990 were included in a historic cohort and followed until December 1993. National cancer rates were uses to calculated expected cancer cases.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
sulfite / sulfur dioxide
IUPAC Name:
sulfite / sulfur dioxide
Details on test material:
- Name of test material (as cited in study report): sulphite

Method

Type of population:
occupational
Ethical approval:
not specified
Details on study design:
HYPOTHESIS TESTED (if cohort or case control study): Studies have indicated an excess risk of stomach cancer, pancreas cancer, and non-Hodgkin's lymphoma for sulfite pulp mill workers, and therefore cancer incidence was evaluated for 2 Danish sulfite mills.

METHOD OF DATA COLLECTION
- Type: Record review
- Details: Cancer incidence was evaluated for 2 Danish sulphite mills. 2238 persons (only 102 women) employed in 1955-1990 were included in a historic cohort and followed until December 1993

STUDY PERIOD: 1955 - 1990, follow up until 1993

SETTING: 2 Danish sulphite mills

STUDY POPULATION
- Total population (Total no. of persons in cohort from which the subjects were drawn): 2238 persons (102 women) were included and followed up to 1993
- Selection criteria: availability of personal identification number for vital status, date of death in the National Mortality Register
- Total number of subjects participating in study: 2198 persons
- Other: For each person, the person-years at risk were calculated from start of employment until death or end of follow-up.

COMPARISON POPULATION
- Type: National registry
- Details: National cancer rates were uses to calculated expected cancer cases.

Exposure assessment:
not specified
Statistical methods:
The standardized incidence ratios (SIR) were calculated by dividing the observed number of cancer cases in a given group by the expected number, and the 95 % confidence intervals were calculated using Byar's approximation.

Results and discussion

Results:
FINDINGS
- The overall cancer risk for all male workers was close to the expected, the standardized incidence ratio (SIR) being 1.01.
- The risk of stomach cancer (10 observed) and pancreatic cancer (7 observed) was doubled (SIR 1.99 and 1.88, respectively).
- For the men with known pulp exposure, lung cancer was slightly increased (SIR 1.53).
- Other cancers with elevated risks were leukaemia (7 cases; SIR 1.84) and soft-tissue sarcomas (4 observed; SIR 2.37).
- The excess risk of stomach cancer and pancreatic cancer found in this study was in accordance with that of other studies from sulphite pulp mills.

Confounding factors:
smoking or possibly asbestos used in the industry
Strengths and weaknesses:
no exposure level could be derived

Applicant's summary and conclusion

Conclusions:
This retrospective cohort study in Danish sulphite pulp mill workers had a 2-fold increased risk for stomach cancer and pancreatic cancer (Rix et al., 1997). Other cancers with elevated risks were leukaemia (SIR 1.84) and soft-tissue sarcomas (SIR 2.37). The increased risk for stomach cancer found in this study was in accordance with that of other studies from sulphite pulp mills.