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Toxicological information

Epidemiological data

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Administrative data

Endpoint:
epidemiological data
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: There are no guidelines for cancer epidemiological studies. The study includes all reasonable aspects of such studies and the numbers of subjects and follow up duration are sufficient.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2002

Materials and methods

Study type:
cohort study (prospective)
Endpoint addressed:
carcinogenicity
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Prospective cohort study using cause of death data comparison to UK mortality statistics.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The epidemiological studies discussed were of workers potentially exposed to MDI and/or TDI. These are generic terms used for commercial products containing various proportions of the MDI or TDI types in REACH registration. The studies reported here are valid for all MDI and TDI types.

Method

Ethical approval:
confirmed and informed consent free of coercion received

Results and discussion

Results:
No significant positive trends were found between risks of lung cancer or risks of non-malignant diseases of the respiratory system and durations
of "lower" or "higher" exposures to diisocyanates.

Any other information on results incl. tables

Compared with the general population of England and Wales, mortality from lung cancer in female employees was significantly increased (observed (Obs] 35, expected (Exp) 19.4, standardised mortality ratio (SMR) 181). A similar excess was not found for male employees (Obs 134, Exp 125.0, SMR 107). There were no significantly increased cause specific SMRs among the subcohort (n = 1782) with some period of isocyanate exposed employment. No significant positive trends were found between risks of lung cancer or risks of non-malignant diseases of the respiratory system and durations of "lower" or "higher" exposures to diisocyanates.

Applicant's summary and conclusion

Conclusions:
The study has been unable to link isocyanate exposed employment either with risks of lung cancer or with risks of non-malignant diseases of the
respiratory system. The increased SMR for female lung cancer is most likely caused by factors unrelated to the industry under study.