Registration Dossier
Registration Dossier
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EC number: 201-476-4 | CAS number: 83-43-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Methylprednisolone, Summary Report
- Author:
- The European Agency for the Evaluation of Medicinal Products, Committee for Veterinary Medicinal Products
- Year:
- 2 001
- Bibliographic source:
- The European Agency for the Evaluation of Medicinal Products, Committee for Veterinary Medicinal Products
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Guinea pig maximisation test was conducted in male Hartley guinea pigs.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- None stated
Test material
- Reference substance name:
- Methylprednisolone
- EC Number:
- 201-476-4
- EC Name:
- Methylprednisolone
- Cas Number:
- 83-43-2
- Molecular formula:
- C22H30O5
- IUPAC Name:
- 11,17,21-trihydroxy-6-methylpregna-1,4-diene-3,20-dione
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
No evidence of skin sensitisation.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- The test substance showed no evidence of skin sensitization in male Hartley guinea pigs.
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