Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
no guideline available
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
-Purity: not reported

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: young adult females
- Weight at study initiation: 2336 g, 2166 g
- Housing: singly in suspended wire-mesh cages
- Diet (e.g. ad libitum): approx. 125 g high fiber rabbit chow
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22°C
- Humidity (%): 40-60%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hr light/12 hr dark

Test system

Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.01 g
Duration of treatment / exposure:
20 sec
Observation period (in vivo):
1 hr, 4 hr and days 1, 2, 3 and 7
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 20 sec after exposure

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
The test substance produced mild chemosis and moderate conjunctival redness with hemorrhaging of the conjunctiva and nictitating membrane in the treated washed and unwashed rabbit eyes. In addition, moderate iritis and copious blood-tinged discharge were observed in the treated unwashed eye. Both treated eyes were normal 7 days following treatment.
Other effects:
Both rabbits pawed their treated eye and 1 rabbit vocalized after instillation of the test substance.

Any other information on results incl. tables

Individual eye irritation Draize scores are presented below.

Rabbit Number 29045 (Unwashed)

1 Hour

4 Hours

1 Day

2 Days

3 Days

7 Days

Cornea Opacity

0

0

0

0

0

0

Cornea Area

0

0

0

0

0

0

Iris

0

1

0

0

0

0

Conjunctiva Redness

2

2

2C

2C

2C

0

Conjunctiva Chemosis

2

2

2

1

1

0

Conjunctiva Discharge

2H

3H

1H

0

0

0

Rabbit Number 29046 (Washed)

1 Hour

4 Hours

1 Day

2 Days

3 Days

7 Days

Cornea Opacity

0

0

0

0

0

0

Cornea Area

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjunctiva Redness

2

2

2C

2C

2C

0

Conjunctiva Chemosis

2

2

1

1

1

0

Conjunctiva Discharge

0

0

0

0

0

0

H = Hemastix evaluations positive for blood

C = Hemorrhaging of the conjunctiva and the nictitating membrane

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information
Conclusions:
Under the conditions of this study, the test substance was a moderate eye irritant.
Executive summary:

The test substance was evaluated for acute eye irritation potential in 2 rabbits. Approximately 0.01 g of the test substance was instilled into the lower conjunctival sac of the right eye of each rabbit. Approximately 20 seconds after instillation, the treated and control eyes of 1 rabbit were washed. The treated and control eyes of the remaining rabbit were not washed. The eyes of the rabbits were examined on the day of treatment and on days 1, 2, 3, and 7 following treatment. 

 

The test substance produced mild chemosis and moderate conjunctival redness with hemorrhaging of the conjunctiva and nictitating membrane in the treated washed and unwashed rabbit eyes. In addition, moderate iritis and copious blood-tinged discharge were observed in the treated unwashed eye. Both treated eyes were normal 7 days following treatment.

 

Under the conditions of this study, the test substance was a moderate eye irritant.