Registration Dossier
Registration Dossier
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EC number: 210-848-5 | CAS number: 624-48-6
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only abstract available.
Data source
Reference
- Reference Type:
- publication
- Title:
- Sensitization to dimethyl fumarate with multiple concurrent patch test reactions
- Author:
- Lammintausta K, et al.
- Year:
- 2 010
- Bibliographic source:
- Contact Dermatitis; 62(2):88-96.
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- other: 9 patients were tested
- Principles of method if other than guideline:
- Patch testing with dimethyl fumarate (DMF) in concentrations of 0.1-0.00001% was carried out in 37 patients. Diethyl fumarate (DEF), diethyl maleate (DEM), dimethyl maleate (DMM), ethyl acrylate (EA), methyl acrylate (MA), and methyl methacrylate (MMA) were also tested with a dilution series at equimolar concentrations.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Dimethyl maleate
- EC Number:
- 210-848-5
- EC Name:
- Dimethyl maleate
- Cas Number:
- 624-48-6
- Molecular formula:
- C6H8O4
- IUPAC Name:
- dimethyl (Z)-but-2-enedioate
- Details on test material:
- - Name of test material (as cited in study report): dimethyl maleate (DMM)
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 37
Results and discussion
- Results of examinations:
- DMM reactions were seen in all 9 patients tested.
Applicant's summary and conclusion
- Conclusions:
- In a sensitization study dimethyl maleate showed reactions in all 9 patients tested.
Under the given conditions DMM exhibited skin sensitising potential in human patients.
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