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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1990 (no other information available)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
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 US guideline.

Data source

Reference
Reference Type:
publication
Title:
Acute toxicological evaluation of cerium nitrate
Author:
Lambert CE, Barnum EC, Shapiro R
Year:
1993
Bibliographic source:
J Am Coll Toxicol, 12(6), 615

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
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Cerium nitrate, hexahydrate
IUPAC Name:
Cerium nitrate, hexahydrate
Test material form:
not specified
Details on test material:
- Test material identity: Cerium nitrate (CAS No. 10294-41-4), as cerium (III) nitrate hexahydrate
- Analytical purity: No data
- Impurities: No data
- Lot/batch no.: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data

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: the right eye of each rabbit was untreated
Amount / concentration applied:
undiluted
Amount applied: 0.1 g
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
- Removal of test system: 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:
other: draize scores
Basis:
mean
Time point:
other: 24-48-72 hours
Score:
41 - 42.3
Max. score:
110
Reversibility:
not specified
Remarks on result:
other: Unwashed eyes (3 rabbit mean): 41.0 (24h), 42.3 (48h), 42.3 (72h)
Irritation parameter:
other: draize scores
Basis:
mean
Time point:
other: 24-48-72 hours
Score:
18 - 23
Max. score:
110
Reversibility:
not specified
Remarks on result:
other: Washed eyes (3 rabbit mean): 23.0 (24h), 21.3 (48h), 18.0 (72h)

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Classification: risk of serious damage to eyes;
In this study, cerium nitrate was found to be severely and moderately irritating to unwashed and washed eyes respectively.
Executive summary:

In a primary eye irritation study (Lambert CE, 1993), 0.1 g of cerium nitrate (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 nitrate was found severely irritating to the eye of rabbit.