m-tolylidene diisocyanate

Epidemiological data

Administrative data

Endpoint:

epidemiological data

Type of information:

other: Epidemiological study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Remarks:

. 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

Principles of method if other than guideline:

- Principle of test: Prospective mortality study using death notifications of cohort members compared to UK population statistics for mortality and cancer.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

m-tolylidene diisocyanate

EC Number:

247-722-4

EC Name:

m-tolylidene diisocyanate

Cas Number:

26471-62-5

Molecular formula:

C9H6N2O2

IUPAC Name:

2,4-diisocyanato-1-methylbenzene, 2,6-diisocyanato-1-methylbenzene

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.

Specific details on test material used for the study:

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

Type of population:

occupational

Ethical approval:

confirmed and informed consent free of coercion received

Exposure assessment:

estimated

Results and discussion

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.