Registration Dossier
Registration Dossier
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EC number: 208-655-6 | CAS number: 537-01-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- 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 870.2400 (Acute eye irritation)
- Deviations:
- not specified
- Principles of method if other than guideline:
- other: unknown
- GLP compliance:
- not specified
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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Source, Age at study initiation, Weight at study initiation, Housing, Diet, Water, Acclimation period: data not available
ENVIRONMENTAL CONDITIONS:
- Temperature, Humidity, Air changes, Photoperiod: data not available
IN-LIFE DATES: data not available
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: 3 eyes were rinsed after 30s, 3 other were unrinsed
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 3 of the treated eyes were rinsed with saline 30 seconds post-instillation
SCORING SYSTEM: according to the method of Draize
TOOL USED TO ASSESS SCORE: data not available
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.7 - 6.7
- Max. score:
- 110
- Reversibility:
- not specified
- Remarks on result:
- other: Draize scores: Unwashed eyes (3 rabbit mean): 6.7 (24h), 2.0 (48h), 0.7 (72h)
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.3 - 4.7
- Max. score:
- 110
- Reversibility:
- not specified
- Remarks on result:
- other: Draize scores: Washed eyes (3 rabbit mean): 4.7 (24h), 2.0 (48h), 1.3 (72h)
- Irritant / corrosive response data:
- Cerium carbonate is considered to be minimally irritating to the unwashed and washed eye, but not classified according to EU criteria.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In this study, cerium carbonate is not classified irritating according to EU criteria.
- Executive summary:
In a primary eye irritation study (Lambert CE, 1993), 0.1 g of cerium carbonate (purity unknown) was instilled into the left eye of New Zealand Albino rabbits (6 animals). 3 treated eyes were rinsed after 30 seconds. Animals then were observed for 3 days. Irritation was scored by the method of Draize.
In this study, cerium carbonate is slightly irritant to the eye but not classified according to EU criteria.
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