Registration Dossier
Registration Dossier
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EC number: 203-571-6 | CAS number: 108-31-6
Respiratory sensitisation
Administrative data
- Endpoint:
- respiratory sensitisation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well-documented study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- publication
- Title:
- Maleic Anhydride and Maleic Acid
- Author:
- UNEP
- Year:
- 2 005
- Bibliographic source:
- Published OECD SIDS initial assessments of HPV chemicals (2005)
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- 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:
- furan-2,5-dione
- Details on test material:
- Maleic anhydride
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Test system
- Route of induction exposure:
- inhalation
- Route of challenge exposure:
- inhalation
- Vehicle:
- unchanged (no vehicle)
- Concentration:
- 500 µg/m3
- No. of animals per dose:
- 10/sex
Results and discussion
- Results:
- According to this study maleic anhydride is an ambiguous respiratory sensitizer to rats. It showed that maleic anhydride-exposed/maleic anhydride-challenged animals had small, but statistically significant (p < 0.05), increases in maleic anhydride-specific serum IgG antibody compared to the controls. However, other prominent features of respiratory sensitization reactions in this model (such as increased numbers of external hemorrhagic lung foci, increased lung weight and volume, and extensive lung pathology) were not evident.
Any other information on results incl. tables
Nothing.
Applicant's summary and conclusion
- Interpretation of results:
- ambiguous
- Conclusions:
- According to this study maleic anhydride is an ambiguous respiratory sensitizer to rats.
- Executive summary:
Nothing to be added in this field.
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