Registration Dossier
Registration Dossier
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EC number: 201-476-4 | CAS number: 83-43-2
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- publication
- Title:
- Methylprednisolone-induced hepatotoxicity in a 16-year-old girl with multiple sclerosis
- Author:
- Rotondo E, Graziosi A, Di Stefano V, Mohn AA
- Year:
- 2 018
- Bibliographic source:
- BMJ Case Rep. 2018. Dec 7;11(1):e226687. doi: 10.1136/bcr-2018-226687
Materials and methods
- Study type:
- clinical case study
- Endpoint addressed:
- other: repeated dose toxicity: intravenous
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
- Details on test material:
- No data given
Constituent 1
Method
- Subjects:
- 16-year-old girl
- Route of exposure:
- other:
- Reason of exposure:
- intentional, occupational
- Details on exposure:
- treated with a 5-day course of intravenous methylprednisolone (total dose 1.0 g/day)
Results and discussion
- Clinical signs:
- acute liver injury with urticaria on the chest and limbs, angioedema, nausea and vomiting
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
