Registration Dossier
Registration Dossier
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EC number: 293-671-6 | CAS number: 91081-64-0 Slag produced during ilmenite smelting (ore or sand). Consists primarly of TiO2, FeO, Al2O3, SiO2, MgO and other metal oxides.
Epidemiological data
Administrative data
- Endpoint:
- epidemiological data
- Type of information:
- other: human case
- Adequacy of study:
- supporting study
- Rationale for reliability incl. deficiencies:
- other: Review on epidemiological data for TiO2 exposure (data considered under IARC review Vol. 93). Review considered as duplicate to the IARC review, therefore not futher considered.
Data source
Reference
- Reference Type:
- publication
- Title:
- Carcinogenicity of carbon black, titanium dioxide, and talc
- Author:
- Baan, R.; et al.
- Year:
- 2 006
- Bibliographic source:
- The Lancet 7, 295-296
Materials and methods
- Study type:
- other: cohort study and case-control
- Endpoint addressed:
- carcinogenicity
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Assessment of the risk of cancer in the respiratory tract.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Titanium dioxide
- EC Number:
- 236-675-5
- EC Name:
- Titanium dioxide
- Cas Number:
- 13463-67-7
- Molecular formula:
- O2Ti
- IUPAC Name:
- dioxotitanium
- Reference substance name:
- Rutile (TiO2)
- EC Number:
- 215-282-2
- EC Name:
- Rutile (TiO2)
- Cas Number:
- 1317-80-2
- IUPAC Name:
- dioxotitanium
- Details on test material:
- - Name of material: Titanium dioxide
Constituent 1
Constituent 2
Method
- Type of population:
- other: Occupational and general
- Ethical approval:
- not specified
- Details on study design:
- This is a review summarizing details from different studies:
1).The largest epidemiological cohort study (Boffetta, P. Soutar, A. Cherrie, J.W. et al.. mortality among workers employed in the titanium dioxide production industry in Europe. Cancer Causes Control 2004; 15: 697 -706) considered included workers in the titanium dioxide production industry in six European countries.
2)Two cohort studies undertaken in the USA and one Canadian population-based case-control study were mentioned in the review. - Exposure assessment:
- not specified
- Details on exposure:
- No data
- Statistical methods:
- No data
Results and discussion
- Results:
- 1). The epidemiological cohort study showed a small but significant increase in risk of lung cancer compared with that for the general population; however, the data did not suggest an exposure-response relation.
2). The two cohort studies undertaken in the USA did not report excess risks of lung cancer, neither did the Canadian population-based case-control study.
Overall, a working group concluded that the epidemiological studies on titanium dioxide provide inadequate evidence of carcinogenicity.
Applicant's summary and conclusion
- Conclusions:
- 1). The epidemiological cohort study showed a small but significant increase in risk of lung cancer compared with that for the general population; however, the data did not suggest an exposure-response relation.
2). The two cohort studies undertaken in the USA did not report excess risks of lung cancer, neither did the Canadian population-based case-control study.
Overall, a working group concluded that the epidemiological studies on titanium dioxide provide inadequate evidence of carcinogenicity.
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