Registration Dossier
Registration Dossier
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EC number: 206-825-4 | CAS number: 378-44-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The use of secondary sources of data is acceptable when they are based on a critical evaluation of peer-reviewed data and a consequent selection of a reliable and representative value for the property under investigation. Therefore, although the method is unknown, the values presented here are acceptable as they are from a reliable secondary source of biological data.
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 011
- Reference Type:
- grey literature
- Title:
- No information
- Year:
- 1 979
- Bibliographic source:
- Gekkan Yakuji. Pharmaceuticals Monthly, 1979, 21, 2117
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- No data on materials and methods are reported in the RTECS database. It was not possible to obtain the japanese written original article. Thus, the use of secondary sources of data is acceptable when they are based on a critical evaluation of peer-reviewed data and a consequent selection of a reliable and representative value for the property under investigation.
- GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Reference substance name:
- Betamethasone
- EC Number:
- 206-825-4
- EC Name:
- Betamethasone
- Cas Number:
- 378-44-9
- Molecular formula:
- C22H29FO5
- IUPAC Name:
- 9-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 4 500 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
Details of toxic effects not reported.
It was reported only the disclosed value, also in the original paper.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Because of LD50 > 4500 mg/kg bw Betamethasone was considered non toxic for acute oral administration.
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