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Registration Dossier
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EC number: 235-043-6 | CAS number: 12060-58-1
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: Basic data given (comparable to guidelines/standards)
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guideline of the Department of Transportation (D.O.T), Code of Federal Regulations, Title 49, Part 173
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Lanthanum carbonate
- IUPAC Name:
- Lanthanum carbonate
- Reference substance name:
- 54451-24-0
- EC Number:
- 611-146-5
- Cas Number:
- 54451-24-0
- IUPAC Name:
- 54451-24-0
- Details on test material:
- - Name of test material (as cited in study report): Rare Earth Carbonate #1451
- Molecular formula (if other than submission substance): La2(CO3)3*H2O
- Analytical purity: no data
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Taconic Farms Inc.
- Weight at study initiation: males: 113 g, females: 109 g
- Fasting period before study: overnight
- Housing: 5 per wire mesh suspended cage
- Diet: Purina laboratory Chow, freely available
- Water: freely available
- Acclimation period: 7 days
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50%
MAXIMUM DOSE VOLUME APPLIED: 6.0 -7.5 mL - Doses:
- Range finding: 3980, 6320 and 10000 mg/kg
Main study: 31600 mg/kg - No. of animals per sex per dose:
- Range finding: 2 (no information about sex)
Main test: 5 - Control animals:
- no
- Details on study design:
- - Clinical signs were noted immediately after dosing and at 4, 24 and 48 hours
- Body weight were recorded at dosing and at 48 h
- Animals found dead or terminated after 48 h were subjected to a macroscopic examination of the viscera
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 30 404 mg/kg bw
- Remarks on result:
- other: recalculated value to Lanthanum carbonate
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 31 600 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: original value: Lanthanum carbonate monohydrate
- Mortality:
- Range finding: no mortality after 48 h
Main study: no mortality after 48 h - Clinical signs:
- other: Animals appeared normal after dosing
- Gross pathology:
- Macroscopic changes were not observed in the viscera.
Applicant's summary and conclusion
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