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Registration Dossier
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EC number: 233-899-5 | CAS number: 10421-48-4
Epidemiological data
Administrative data
- Endpoint:
- epidemiological data
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Publication, reasonably documented, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Mortality among workers employed in the titanium dioxide production industry in Europe.
- Author:
- Boffetta P et al.
- Year:
- 2 004
- Bibliographic source:
- Cancer Causes and Control, 15: 697-706.
Materials and methods
- Study type:
- other: epidemiological
- Endpoint addressed:
- carcinogenicity
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Epidemiology study: association of cancer incidence and iron exposure in titanium dioxide workers
- GLP compliance:
- no
Test material
- Reference substance name:
- Iron sulphate
- EC Number:
- 231-753-5
- EC Name:
- Iron sulphate
- Cas Number:
- 7720-78-7
- IUPAC Name:
- iron(2+) sulfate
- Test material form:
- not specified
- Details on test material:
- No details
Constituent 1
Method
- Type of population:
- occupational
- other: Titanium dioxide workers
- Ethical approval:
- not specified
- Details on study design:
- Inhalation exposure assessment
Type of experience: Human - epidemiology.
Workers involved in the manufacture of titanium dioxide frequently also come into contact with copperas (iron II sulphate). This extensive study,
although not designed to identify effects other than those due to titanium dioxide, investigated 15,017 workers (cohort represented 371,067
person-years), and showed standardized mortality ratios (SMRs) of 0.87 (95 confidence interval [CI] 0.83-0.90) among men and 0.58 (95 CI 0.40-0.82) among women. Among men, the SMR of lung cancer was significantly increased (1.23, 95 CI 1.10-1.38); however, mortality from lung cancer did not increase with duration of employment or estimated cumulative exposure to TiO2 dust. Data on smoking were available for over one third of cohort members. In three countries, the prevalence of smokers was higher among cohort members compared to the national populations. The results of the study did not suggest a carcinogenic effect of TiO2 dust on the human lung and from this, it may be inferred that concomitant
exposure to copperas was without effect on the SMRs - Exposure assessment:
- not specified
- Details on exposure:
- Type of experience: Human - epidemiology.
Workers involved in the manufacture of titanium dioxide frequently also come into contact with copperas (iron II sulphate). This extensive study,
although not designed to identify effects other than those due to titanium dioxide, investigated 15,017 workers (cohort represented 371,067
person-years), and showed standardized mortality ratios (SMRs) of 0.87 (95 confidence interval [CI] 0.83-0.90) among men and 0.58 (95 CI 0.40-0.82) among women. Among men, the SMR of lung cancer was significantly increased (1.23, 95 CI 1.10-1.38); however, mortality from lung cancer did not
increase with duration of employment or estimated cumulative exposure to TiO2 dust. Data on smoking were available for over one third of cohort
members. In three countries, the prevalence of smokers was higher among cohort members compared to the national populations. The results of the study did not suggest a carcinogenic effect of TiO2 dust on the human lung and from this, it may be inferred that concomitant
exposure to copperas was without effect on the SMRs
Results and discussion
- Results:
- Workers involved in the manufacture of titanium dioxide frequently also come into contact with copperas (iron II sulphate). This extensive study,
although not designed to identify effects other than those due to titanium dioxide, investigated 15,017 workers (cohort represented 371,067
person-years), and showed standardized mortality ratios (SMRs) of 0.87 (95 confidence interval [CI] 0.83-0.90) among men and 0.58 (95 CI 0.40-0.82) among women. Among men, the SMR of lung cancer was significantly increased (1.23, 95 CI 1.10-1.38); however, mortality from lung cancer did not
increase with duration of employment or estimated cumulative exposure to TiO2 dust. Data on smoking were available for over one third of cohort
members. In three countries, the prevalence of smokers was higher among cohort members compared to the national populations. The results of the study did not suggest a carcinogenic effect of TiO2 dust on the human lung and from this, it may be inferred that concomitant
exposure to copperas was without effect on the SMR
Applicant's summary and conclusion
- Conclusions:
- Workers involved in the manufacture of titanium dioxide frequently also come into contact with copperas (iron II sulphate). This extensive study,
although not designed to identify effects other than those due to titanium dioxide, investigated 15,017 workers (cohort represented 371,067
person-years), and showed standardized mortality ratios (SMRs) of 0.87 (95 confidence interval [CI] 0.83-0.90) among men and 0.58 (95 CI 0.40-0.82) among women. Among men, the SMR of lung cancer was significantly increased (1.23, 95 CI 1.10-1.38); however, mortality from lung cancer did not
increase with duration of employment or estimated cumulative exposure to TiO2 dust. Data on smoking were available for over one third of cohort
members. In three countries, the prevalence of smokers was higher among cohort members compared to the national populations. The results of the study did not suggest a carcinogenic effect of TiO2 dust on the human lung and from this, it may be inferred that concomitant
exposure to copperas was without effect on the SMR - Executive summary:
Workers involved in the manufacture of titanium dioxide frequently also come into contact with copperas (iron II sulphate). This extensive study,
although not designed to identify effects other than those due to titanium dioxide, investigated 15,017 workers (cohort represented 371,067
person-years), and showed standardized mortality ratios (SMRs) of 0.87 (95 confidence interval [CI] 0.83-0.90) among men and 0.58 (95 CI 0.40-0.82) among women. Among men, the SMR of lung cancer was significantly increased (1.23, 95 CI 1.10-1.38); however, mortality from lung cancer did not
increase with duration of employment or estimated cumulative exposure to TiO2 dust. Data on smoking were available for over one third of cohort
members. In three countries, the prevalence of smokers was higher among cohort members compared to the national populations.
The results of the study did not suggest a carcinogenic effect of TiO2 dust on the human lung and from this, it may be inferred that concomitantexposure to copperas was without effect on the SMR
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