Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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.