Registration Dossier

Diss Factsheets

Toxicological information

Sensitisation data (human)

Currently viewing:

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:
2004
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:
1986
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

Constituent 1
Chemical structure
Reference substance name:
Maleic anhydride
EC Number:
203-571-6
EC Name:
Maleic anhydride
Cas Number:
108-31-6
Molecular formula:
C4H2O3
IUPAC Name:
furan-2,5-dione

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.

Categories Display