Registration Dossier
Registration Dossier
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EC number: 231-177-4 | CAS number: 7440-69-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Literature publication with adequate description.
Data source
Reference
- Reference Type:
- publication
- Title:
- Oral toxicity of bismuth in rat: Single and 28-day repeated administration studies.
- Author:
- Sano Y, Satoh H, Chiba M, Okamoto M, Serizawa K, Nakashima H, Omae K.
- Year:
- 2 005
- Bibliographic source:
- Journal of Occupational Health 47, 293-298
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Bismuth
- EC Number:
- 231-177-4
- EC Name:
- Bismuth
- Cas Number:
- 7440-69-9
- Molecular formula:
- Bi
- IUPAC Name:
- bismuth
- Details on test material:
- Purity: 99.9%
Supplier: Kojundo Chemical Laboratory Co. Japan
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan
- Age at study initiation: 5 weeks
- Weight at study initiation: 128-176 g
- Fasting period before study: ca 18 hours
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 15
- Air changes (per hr): 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: depending on target concentration
- Amount of vehicle (if gavage): 10 ml/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Range finding study (each one animal with 1000 and 2000 mg/kg bw) - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- Dosing volume: 10 ml/kg
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No adverse findings
- Mortality:
- None
- Clinical signs:
- other: None
- Gross pathology:
- None
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The authors found no deaths and no abnormalities in clinical signs, body weights, and necropsy findings for any of the animals in the acute oral toxicity study.
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