Registration Dossier

Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Does not include experimental toxicological data. Review of the trends in diisocyanate associated occupational asthma in several EU Member States.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Type of sensitisation studied:
respiratory
Study type:
other: Review of available data on diisocyanate related occupational asthma. Information was collected from published reports in scientific literature, data from government and agency websites and personal information from clinical institutes.
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
This study report aimed at compiling EU national data on isocyanate exposed workforces/professions/work activities and numbers of individuals involved. Data on national isocyanate-related asthma cases and the strength of diagnosis and other relevant factors are included. Germany and Austria are not included in this report.
GLP compliance:
no
Remarks:
Not relevant

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
not specified
Details on test material:
Commercial Diisocyanates of all types included in this review.

Method

Type of population:
occupational
Ethical approval:
not specified
Subjects:
Diisocyanate exposed workers
Details on study design:
Review of available data on diisocyanate related occupational asthma. Information was collected from published reports in scientific literature, data from government and agency websites and personal information from clinical institutes.

Results and discussion

Results of examinations:
Overall, various recent data on isocyanate related asthma incidence indicates a reduction in cases in the last decade. Where controls and current exposure standards are met, new asthma cases can be eliminated.

Any other information on results incl. tables

While there is some indication of a downward trend in isocyanate associated occupational asthma (OA) in some countries (in particular France and Belgium), the number of cases in other countries remain steady, or possibly rising (Czech Republc). With the low numbersof cases, any small outbreak of OA will also have a large impact on such figures.

There is evidence of over-reporting of OA with about 50 to 60% of suspected cases appearing on registers actually being confirmed. This is counterbalanced by reports suggesting there is , in general, under-reporting of OA.

While tests are available to identify specific agents responsible for inducing the hypersensitive state, such tetsing is not applied in the majority of the cases, with diagnosis relying on clinical diagnosis and labour anamnesis.

There is some indication that isocyanate OA might be associated with certain occupation/jobs using spray applications, but information is sparse and not supported by all data.

Applicant's summary and conclusion

Conclusions:
Overall, various recent data on isocyanate related asthma incidence indicates a reduction in cases in the last decade. Where controls and current exposure standards are met, new asthma cases can be eliminated.