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EC number: 272-296-1 | CAS number: 68797-35-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1960
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Not specified
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- α-d-Glucopyranosiduronic acid, (3β,20β)-20-carboxy-11-oxo-30-norolean-12-en-3-yl 2-O-β-d-glucopyranuronosyl-, dipotassium salt
- EC Number:
- 272-296-1
- EC Name:
- α-d-Glucopyranosiduronic acid, (3β,20β)-20-carboxy-11-oxo-30-norolean-12-en-3-yl 2-O-β-d-glucopyranuronosyl-, dipotassium salt
- Cas Number:
- 68797-35-3
- Molecular formula:
- C42H62O16.2K
- IUPAC Name:
- α-d-Glucopyranosiduronic acid, (3β,20β)-20-carboxy-11-oxo-30-norolean-12-en-3-yl 2-O-β-d-glucopyranuronosyl-, dipotassium salt
- Reference substance name:
- unknown constituent
- IUPAC Name:
- unknown constituent
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Products of Maruzen Pharmaceuticals Company limited
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Weight : between 13 and 17 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- With the use of stomach canula, the 10% solution was administered orally.
- Doses:
- 4000, 4500, 5000, 5500, 6000, 6500, 7000 mg/kg dose
- No. of animals per sex per dose:
- 6 healthy mice was used for each materials
- Control animals:
- not specified
- Details on study design:
- The animals were kept 7 days after administration of the treatment and observed after 168hours for the mortality.
- Statistics:
- LD50 and confidence limit at 95% were calculated by Lictchfield-Wilcoxon method.
Results and discussion
- Preliminary study:
- Not specified
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 8 100 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 7 700 - <= 8 500
- Mortality:
- For each group given 5000 mg/kg and 6500 mg/kg doses, only onse mouse of eac group died but the rest survived. At above 7000 mg/kg dose animal started dying.
- Clinical signs:
- other: Not specified
- Gross pathology:
- Not specified
- Other findings:
- Not specified
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The acute oral LD50 of the substance is 8100 mg/kg bw in mice. The test item exhibit extremely low toxicity.
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