Registration Dossier
Registration Dossier
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EC number: 235-060-9 | CAS number: 12064-62-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Published data with limited level of detail. Only one dose tested, lower than the limit test dose.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 963
- Report date:
- 1963
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Digadolinium trioxide
- EC Number:
- 235-060-9
- EC Name:
- Digadolinium trioxide
- Cas Number:
- 12064-62-9
- Molecular formula:
- Gd2O3
- IUPAC Name:
- Digadolinium trioxide
- Details on test material:
- No further data available
Constituent 1
- Specific details on test material used for the study:
- Gd2O3 was obtained from the St. Eloi Corporation, Cincinnati, Ohio, USA.
Purity: > 98%
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Females (if applicable) nulliparous and non-pregnant: No data
- Age at study initiation: Adult
- Weight at study initiation: 190-250 g
- Fasting period before study: No data
- Housing: air-conditioned quarters
- Diet (e.g. ad libitum): ad libitum, Rockland Rat diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): air conditioned
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: No data To: No data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- aqueous 0.2% solution of CMC
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50% suspension
- Amount of vehicle (if gavage): No data - Doses:
- 1000 mg/kg (only dose tested)
- No. of animals per sex per dose:
- 20 females
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 30 days
- Other examinations performed: clinical signs - Statistics:
- LD50 and 95% confidence limits were calculated by the method of Litchfield and Wilcoxon (1949).
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No data
- Clinical signs:
- other: No data
- Gross pathology:
- No data
- Other findings:
- No data
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The LD50 of the test item for female rats was found to be > 1000 mg/kg body weight.
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