Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
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, 20-23 April 2004

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
No guideline available found in the published report.
GLP compliance:
not specified
Type of study:
not specified
Justification for non-LLNA method:
guinea pigs study

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:
2,5-dihydrofuran-2,5-dione

In vivo test system

Test animals

Species:
guinea pig

Study design: in vivo (non-LLNA)

Induction
Route:
other: not available
Vehicle:
not specified
Concentration / amount:
not available
Day(s)/duration:
not available
Adequacy of induction:
not specified
Challenge
Route:
other: not available
Vehicle:
not specified
Concentration / amount:
not available
Day(s)/duration:
not available
Adequacy of challenge:
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
other: not available
Group:
other: not available
Dose level:
not available
Clinical observations:
not available
Remarks on result:
other: not available

Applicant's summary and conclusion

Conclusions:
Maleic anhydride has been shown to be a skin sensitizer to guinea pigs.