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
- Study period:
- no data available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well described publication.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Oral toxicity of bismuth in rat: Single and 28-day repeated administration studies.
- Author:
- Sano, Y.; et al.
- 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)
- Deviations:
- no
- GLP compliance:
- not specified
- Test type:
- standard acute 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:
- - Name of test material (as cited in study report): Bismuth
- Mean particle diameter: 10 µm
- Storage condition of test material: at room temperature
- Purity: 99.9%
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, Inc.
- Age at study initiation: At the start of administration, animals were 5 weeks old
- Weight at study initiation: 128-154 g, 113-127 g, 154-176 g and 128-147 g, respectively
- Fasting period before study: the animal was fasted for about 18 hours prior to dosing
- Diet: The animals were fed a pellet diet (MF, Oriental Yeast Co., Ltd.)
- Water: ad libitum; tap water inradiated by UV rays after passing through a 5-µm filter
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 15
- Air changes (per hr): about 12 changes per hour
- Photoperiod: 12 hours dark/light cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: The dosing volume was set at 10 mL/kg, and the dose volume for individual animals was calculated based on the body weight measured just before dosing.
No further details are given. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- five male and five female rats
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes.
- Other examinations performed: clinical signs, body weight, organ weights, histopathology,
- Frequency of observations and weighing: Clinical signs of the animals were observed four times on the dose day and thereafter once a day. The body weights of all animals and the gross weights of the feeders were measured before dosing and on days 4, 8, and 15 (the day of administration was designed as day 1). - Statistics:
- A multiple comparison test to analyse statistical significance in the numerical data (body weight, food consumption, haematology, blood chemistry, and organ weights) was used. Statistical significance in graded categorical data (urinalysis, necropsy findings and histopathological findings) was analysed by a x b chi-square test. A significance level of 5% and 1% was set for all statistical analysis.
Results and discussion
- Preliminary study:
- Since there were no deaths during a preliminary study doses of 1000 and 2000 mg/kg (one rat of each sex at each dose), a dosage of 2000 mg/kg was set for this study.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: No abnormal clinical signs in any animals were found.
- Gross pathology:
- No histopathological abnormalities attributed to bismuth were observed.
- Other findings:
- No further findings are reported.
Any other information on results incl. tables
Based on the results, the lethal dose 50% mortality rate (LD50) dosage was greater than 2000 mg/kg for both sexes.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results, the lethal dose 50% mortality rate (LD50) dosage was greater than 2000 mg/kg for both sexes.
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