Registration Dossier
Registration Dossier
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EC number: 701-017-2 | CAS number: -
Epidemiological data
Administrative data
- Endpoint:
- epidemiological data
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- 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:
- 2 002
Materials and methods
- Study type:
- cohort study (prospective)
- Principles of method if other than guideline:
- Prospective mortality study using death notifications of cohort members compared to UK population statistics for mortality and cancer.
- GLP compliance:
- no
Test material
- Reference substance name:
- m-tolylidene diisocyanate
- EC Number:
- 247-722-4
- EC Name:
- m-tolylidene diisocyanate
- Cas Number:
- 26471-62-5
- IUPAC Name:
- 2,4-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.
Constituent 1
Method
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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