Registration Dossier
Registration Dossier
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EC number: 431-870-3 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 Nov. 1998 to 15 Dec. 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD method and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Vehicle:
- other: Arachis oil BP.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 300 - <= 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 200 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 3
Female: 200 mg/kg bw; Number of animals: 3; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: Deaths were noted at a dose level of 2000mg/kg. There were no deaths at a dose level of 200mg/kg. Signs of toxicity noted at a dose level of 2000mg/kg were hunched posture, lethargy, ataxia decreased respira
- Gross pathology:
- Effects on organs:
Dose level 2000mg/kg = haemorrhagic lungs, dark liver, pale spleen, dark kidneys, pale appearance of the gastric mucosa and haemorrhage of the small intestine.
Dose level 200mg/kg = No abnormalities were detected.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD 50 is estimated to be 300-500 mg/kg and classified as acute toxic class 4.
- Executive summary:
BMS 217947 -01 was tested for acute oral toxicity on Sprague-Dawley male and female rats, according to EU Test Method B.1 bis (fixed dose procedure) and OECD Test Guideline 423. No deaths were observed on 3 male and 3 female rats at the 200 mg/kg bw dose, while all 3 female rats died at the dose level of 2000 mg/kg bw. Based on this, the oral LD50 for the substance was estimated to be 300 - 500 mg/kg bw. This is sufficient to classify the substance as acute toxic, categorty 4, according to CLP.
No clinical signs or adverse effects were observed at the 200 mg/kg bw dose level.
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