Registration Dossier
Registration Dossier
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EC number: 604-165-5 | CAS number: 139893-43-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: no data
- Principles of method if other than guideline:
- no data
- GLP compliance:
- no
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- Simvastatin
- IUPAC Name:
- Simvastatin
Constituent 1
Test animals
- Species:
- mouse
Administration / exposure
- Route of administration:
- oral: feed
- Doses:
- 9 g/m2 mice
30 g/m2 rats
100 g/m2 dogs
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- ca. 3 000 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:
- Acute and Local Toxicity – Significant lethality was observed in mice after a single oral dose of 9 g/m2. No evidence of lethality was observed in rats or dogs treated with doses of 30 and 100 g/m2, respectively. No specific diagnostic signs were observed in rodents. At these doses the only signs seen in dogs were emesis and mucoid stools2. Oral LD50 values in the dog, mouse and rat models were >5000, 3000 and 4438 mg/kg, respectively1.
- Executive summary:
Acute and Local Toxicity – Significant lethality was observed in mice after a single oral dose of 9 g/m2. No evidence of lethality was observed in rats or dogs treated with doses of 30 and 100 g/m2, respectively. No specific diagnostic signs were observed in rodents. At these doses the only signs seen in dogs were emesis and mucoid stools2. Oral LD50 values in the dog, mouse and rat models were >5000, 3000 and 4438 mg/kg, respectively1.
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