Registration Dossier
Registration Dossier
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EC number: 203-571-6 | CAS number: 108-31-6
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- other: case report
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Maleic Anhydride and Maleic Acid, SIDS Initial Assessment Report For SIAM 18
- Author:
- OECD SIDS
- Year:
- 2 004
- Bibliographic source:
- OECD SIDS Initial Assessment Report For SIAM 18, Paris, France, 20-23 April 2004
- Reference Type:
- other: secondary source
- Title:
- Occupational exposure caused by maleic anhydride: bronchial provocation testing and immunologic data.
- Author:
- Graneek B. J. et al.
- Year:
- 1 986
- Bibliographic source:
- Thorax 41, 251
Materials and methods
- Type of sensitisation studied:
- respiratory
- Study type:
- case report
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Four cases of asthma in workers exposed to maleic anhydride were reported.
- GLP compliance:
- no
Test material
- Reference substance name:
- Maleic anhydride
- EC Number:
- 203-571-6
- EC Name:
- Maleic anhydride
- Cas Number:
- 108-31-6
- Molecular formula:
- C4H2O3
- IUPAC Name:
- 2,5-dihydrofuran-2,5-dione
Constituent 1
Method
- Type of population:
- occupational
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 4
- Clinical history:
- not specified
- Route of administration:
- other: not specified
Results and discussion
- Results of examinations:
- Inhalation challenge tests: a late asthmatic reaction and increased responsiveness to histamine following inhalation challenge to maleic anhydride in 3 out of 4 workers; IgE specific antibodies in serum equivocal results.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, the case reports suggest that maleic anhydride causes asthma in exposed workers.
- Executive summary:
Four cases of asthma in workers exposed to maleic anhydride were reported in an abstract report. No clinical or exposure histories were presented. Three of the workers showed a late asthmatic reaction and increased responsiveness to histamine following inhalation challenge to maleic anhydride. Only one of had maleic anhydride-specific IgE antibodies present in the serum; these were in low titer and it was thought possible that there may have been a cross reaction to IgE specific for trimellitic anhydride, to which this individual was also exposed to, and to which an immediate response only occurred in an inhalation challenge. The fourth worker, although negative in inhalation testing, had specific serum IgE antibodies present.
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