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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:
1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 85,772
- Lot/batch No.: S-13708-76

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: New Zealand White, H.A.R.E. Rabbits For Research, Hewitt, N.J.
- Housing: Individually in wire mesh suspension cages
- Diet (e.g. ad libitum): Certified Rabbit Chow 5322, Ralston Purina Co., ad libitum
- Water (e.g. ad libitum): Potable water, ad libitum

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 h dark/ 12 h fluorescent light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Left eye served as untreated control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Single treatment
Observation period (in vivo):
14 d; eye irritation scored on Days 1, 2, 3, 4, 7, 10 and 13
Number of animals or in vitro replicates:
Nine
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Eyes in three rabbits rinsed with sterile water for 60 sec
- Time after start of exposure: 30 sec


SCORING SYSTEM: Draize method

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
15.1
Max. score:
110
Reversibility:
not fully reversible within: 13 d
Remarks on result:
other: with washout
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
13.6
Max. score:
110
Reversibility:
not fully reversible within: 13 d
Remarks on result:
other: without washout
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
Mean of 6 animals
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
other:
Remarks:
Without washout
Irritation parameter:
iris score
Basis:
mean
Remarks:
mean of 6 animals
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
other:
Remarks:
Without washout
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
mean of 6 animals
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
other:
Remarks:
With washout
Irritation parameter:
iris score
Basis:
mean
Remarks:
Mean of 6 animals
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
other:
Remarks:
With washout
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.6
Reversibility:
not fully reversible within: 13 d
Remarks on result:
other:
Remarks:
Without washout
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.3
Reversibility:
not fully reversible within: 13 d
Remarks on result:
other:
Remarks:
Without washout
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.67
Reversibility:
not fully reversible within: 13 d
Remarks on result:
other:
Remarks:
Without washout
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.6
Reversibility:
not fully reversible within: 13 d
Remarks on result:
other:
Remarks:
Without washout
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: 13 d
Remarks on result:
other:
Remarks:
Without washout
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2.67
Reversibility:
not fully reversible within: 13 d
Remarks on result:
other:
Remarks:
Without washout
Irritation parameter:
conjunctivae score
Basis:
animal: 7
Time point:
24/48/72 h
Score:
1.67
Reversibility:
not fully reversible within: 13 d
Remarks on result:
other:
Remarks:
With washout
Irritation parameter:
conjunctivae score
Basis:
animal: 8
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: 13 d
Remarks on result:
other:
Remarks:
With washout
Irritation parameter:
conjunctivae score
Basis:
animal: 9
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: 13 d
Remarks on result:
other:
Remarks:
With washout
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3.3
Reversibility:
not fully reversible within: 13 d
Remarks on result:
other:
Remarks:
Without washout
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.3
Reversibility:
not fully reversible within: 13 d
Remarks on result:
other:
Remarks:
Without washout
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3.3
Reversibility:
not fully reversible within: 13 d
Remarks on result:
other:
Remarks:
Without washout
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3
Reversibility:
not fully reversible within: 13 d
Remarks on result:
other:
Remarks:
Without washout
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3
Reversibility:
not fully reversible within: 13 d
Remarks on result:
other:
Remarks:
Without washout
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
3.67
Reversibility:
not fully reversible within: 13 d
Remarks on result:
other:
Remarks:
Without washout
Irritation parameter:
chemosis score
Basis:
animal: 7
Time point:
24/48/72 h
Score:
2.67
Reversibility:
not fully reversible within: 13 d
Remarks on result:
other:
Remarks:
With washout
Irritation parameter:
chemosis score
Basis:
animal: 8
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: 13 d
Remarks on result:
other:
Remarks:
With washout
Irritation parameter:
chemosis score
Basis:
animal: 9
Time point:
24/48/72 h
Score:
3.67
Reversibility:
not fully reversible within: 13 d
Remarks on result:
other:
Remarks:
With washout
Irritant / corrosive response data:
Irritation to the conjunctivae appeared to dissipate but still persisted at the termination of the study.
For details, see 'table 1' and 'table 2'
Other effects:
- No corneal damage at any time
- All treated eyes responded to light and no iridal score was observed in any rabbit
- Discharge, chemosis and redness of the conjunctivae were observed in all animals
- Rinsing appeared to lessen the irritation

Any other information on results incl. tables

Table 1. Ocular irritation (Draize) scores (mean)

Group

No

Washed

1

2

3

4

7

10

13

1

6

No

18.0

15.3

12.0

13.0

13.3

13.0

11.7

2

3

Yes

15.3

13.3

12.0

13.3

12.7

12.0

10.7

Table 2: Mean ocular irritation scores observed at 24, 48 and 72 h

Animal No. Corneal opacity Iritis Conjunctivae Chemosis
1 0 0 2.6 3.3
2 0 0 2.3 3.3
3 0 0 1.67 3.3
4 0 0 2.6 3
5 0 0 2 3
6 0 0 2.67 3.67
7* 0 0 1.67 2.67
8* 0 0 2 2
9* 0 0 2 3.67

* Eyes in three rabbits rinsed with sterile water for 60 sec

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes)
Conclusions:
Under the test conditions, the test material was considered to be irritating to eyes in rabbit.
Executive summary:

A study was conducted to evaluate the ocular toxicity of the test substance in rabbits. The study was performed similar to the OECD Guideline 405. 0.1 mL of the test substance was instilled into the right eye of nine rabbits; the left eye served as an untreated control. One group of six rabbits received no further treatment. In the second group of three rabbits, eyes were rinsed 30 sec post-instillation for 60 sec. Irritation was scored by Draize scoring system at 1, 2, 3, 4, 7, 10 and 13 d post-instillation. Mean irritation scores at 24, 48 and 72 h for animals in group 1 (eyes without washing) were 0/0/2.6/3.3; 0/0/2.3/3.3; 0/0/1.67/3.3; 0/0/2.6/3.0; 0/0/2/3.0 and 0/0/2.67/3.67. Mean irritation scores at 24, 48 and 72 h for animals in group 2 (eyes with washing) were 0/0/1.67/2.67; 0/0/2/2 and 0/0/2/3.67. Irritation to the conjunctivae appeared to dissipate but still persisted at the termination of the study. Mean overall irritation score for 24, 48 and 72 h was 15.1/110 and 13.6/110 in the washed and unwashed eyes, respectively (Chow, 1981).