Registration Dossier
Registration Dossier
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EC number: 219-542-6 | CAS number: 2458-08-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: The LD50 value has been obtained by a secondary source (RTECS database) and it was not possible to assess the quality of the original source.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- No information
- Author:
- Bollettino Chimico Farmaceutico
- Year:
- 1 987
- Bibliographic source:
- (Societa Editoriale Farmaceutica, Via Ausonio 12, 20123 Milan, Italy), 126,282. Available from RTECS database.
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Only the LD50 value for acute oral toxicity in rats is reported.
- GLP compliance:
- not specified
- Test type:
- other: no data are available
Test material
- Reference substance name:
- Ursodeoxycholic acid
- EC Number:
- 204-879-3
- EC Name:
- Ursodeoxycholic acid
- Cas Number:
- 128-13-2
- IUPAC Name:
- 3,7-dihydroxycholan-24-oic acid
Constituent 1
Test animals
- Species:
- rat
- 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:
- 4 600 mg/kg bw
- Based on:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 in rats is 4600 mg/kg bw.
- Executive summary:
After oral administration to rats, the acute LD50 for the similar substance ursodeoxycholic acid is 4600 mg/kg bw.
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