Registration Dossier

Toxicological information

Epidemiological data

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Administrative data

Endpoint:
epidemiological data
Type of information:
other: human case
Adequacy of study:
supporting study
Reliability:
other: not rated acc. to Klimisch
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 further considered.

Data source

Reference
Reference Type:
review article or handbook
Title:
Carcinogenicity of carbon black, titanium dioxide, and talc
Author:
Baan, R.; et al.
Year:
2006
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
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of material: Titanium dioxide

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.
Confounding factors:
not applicable
Strengths and weaknesses:
not applicable

Applicant's summary and conclusion

Conclusions:
The authors stated the following:
1) A 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) 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.