Registration Dossier

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:
2005
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
Name:
Unnamed
Type:
Constituent
Details on test material:
Maleic anhydride

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.