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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 April 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Name of test material (as cited in study report): cerium nitrate ceriammonique 99.5

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: several accredited breeders supply animals to the Hazleton laboratories: Charles River, E.G.A.V. and Elevage Scientifique des Dombes
- Age at study initiation: no data
- Weight at study initiation: 2.5 kg ± 200 g
- Housing: individual polystyrene cages, measuring 540 x 360 x 315 mm with a perforated polystyrene floor in a ventilated and air conditioned room.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 8 days to allow time for acclimatization

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3 °C throughout the year
- Humidity (%): 30 - 70%
- Air changes (per hr): 12 to 14 times per hour (pre-filtered air: 5 - 10 µ)
- Photoperiod (hrs dark / hrs light): lighting is artificial for 12 hours per day

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
The upper and lower eyelids are held together for ten seconds after administration to avoid any loss of test substance.
3 rabbits: wash-out after 4 seconds
3 other rabbits: wash-out after 30 seconds
Observation period (in vivo):
The examinations are always carried out under the same conditions in particular for the lighting. They are made by comparison with the control eye, 1hour after the instillation, and then 24, 48 and 72 hours later. For evaluating the reversibility or irreversibility of the lesions the observation period was prolonged for 7 days.
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes of 3 rabbits are washed out 4 seconds after the instillation, care being taken not to cause injury, and on the 3 other animals 30 seconds after the pplication of the test substance. About 50 mL of the rinsing solution at about 20°C is administered using a plastic jet at moderate pressure. The control eye is washed out under the same conditions as the treated one. The excess of liquid is immediately wiped away with a Codex hydrophilic gauze pad.

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp / Heine's ophtalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24,48, 72 hours
Score:
3.94
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: chemosis
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1.89
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: redness
Irritant / corrosive response data:
On day 7 total necrosis of the eye was observed with loss of the vitreous humor of the eye in 3 of 6 rabbits. In the other 3 rabbits, the observed lesions were not reversible.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the conditions of the test the substance was observed to be severely irritating. Based on the criteria of the CLP Regulation, the substance is classified as Irreversible effects on the eye category 1.