Registration Dossier
Registration Dossier
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EC number: 208-655-6 | CAS number: 537-01-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- data not available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The test is presented in a short summary. However, the information necessary for the assessment are given, and the test conditions are in accordance with those of the recognised EC or OECD guidelines. In order to limit vertebrate animal testing as far as possible, no other test has been performed. In addition, similar results were observed on analogues (other rare earth carbonates).
Data source
Reference
- Reference Type:
- publication
- Title:
- Acute toxicological evaluation of cerium carbonate
- Author:
- Lambert CE, Barnum EC, Shapiro R
- Year:
- 1 993
- Bibliographic source:
- J. Am. Coll. Toxicol. 12(6): 631
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: similar to EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- not specified
- Principles of method if other than guideline:
- other: unknown
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Cerium carbonate (CAS 5853-16-7), hydrated form
- IUPAC Name:
- Cerium carbonate (CAS 5853-16-7), hydrated form
- Details on test material:
- - Test material identity: Cerium carbonate (CAS 5853-16-7)
- Molecular formula: C-H2-O3.2/3Ce.5H2-O
- Molecular weight: 730.5 g
- InChI: Carbonic acid, cerium(3+) salt (3:2), pentadecahydrate
- Analytical purity: data not available
- Impurities: data not available
- Lot/batch No: data not available
- Expiration date of the lot/batch: data not available
- Stability under test conditions: data not available
- Storage condition of test material: data not available
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Species: COMMON SPECIES: rat
- Strain: RAT STRAINS: Sprague-Dawley
- Sex: male/female
- Fasting period before study: yes
- Source, Age at study initiation, Weight at study initiation, Housing, Food consumption, Water consumption, Acclimation period: data not available
ENVIRONMENTAL CONDITIONS:
- Temperature, Humidity, Air changes, Photoperiod: data not available
In-life dates: data not available
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50% = 500 mg/ml
- Amount of vehicle (if gavage): data not available
- Justification for choice of vehicle: standard vehicle
- Purity: distilled water
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
DOSAGE PREPARATION (if unusual): no - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: data not available
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs - Statistics:
- not applicable
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- data not available
- Clinical signs:
- other: data not available
- Gross pathology:
- data not available
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Oral LD50 Combined male/female > 5000 mg/kg bw
- Executive summary:
In an acute oral toxicity study (Lambert CE et al, 1993), groups of fasted, Sprague-Dawley rats (5/sex) were given a single oral dose of cerium carbonate (purity unknown) in distilled water at dose of 5000 mg/kg bw and observed for 14 days.
Oral LD50 Combined male/female > 5000 mg/kg bw
Cerium carbonate is not classified based on the LD50 in males and females.
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