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:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (no GLP)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Trade name: Product 495
- Description of test material: transparent, viscous liquid
- 97% ethyl-2-cyanoacrylate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye
Amount / concentration applied:
0.1 ml of ethyl cyanoacrylate
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
24, 48 and 72 hours after instillation of ethyl cyanoacrylate
Number of animals or in vitro replicates:
9 male rabbits
Details on study design:
A dosage of 0.1 ml of ethyl cyanoacrylate was introduced into the conjunctival sac of the right eye of each rabbit; the left eye served as an untreated control.
The nine treated rabbit eyes were scored against the corresponding untreated control eyes at 24, 48 and 72 hours after instillation of ethyl cyanoacrylate.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
29.33
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
15.33
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
9.66
Reversibility:
not specified
Remarks:
72h observation period
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
1.44
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
48 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
0.56
Reversibility:
not specified
Remarks:
72h observation period
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
0.78
Irritation parameter:
iris score
Basis:
mean
Time point:
48 h
Score:
0.44
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
0.22
Reversibility:
not specified
Remarks:
72h observation period
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
2.33
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
1.11
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
0.66
Reversibility:
not specified
Remarks:
72h observation period
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
2.11
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
0.56
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
0.22
Reversibility:
not specified
Remarks:
72h observation period

Any other information on results incl. tables

 

 

Rabbit number

 

Hours

 

1

2

3

4

5

6

7

8

9

Group Mean Score

24

I. Cornea

 

 

 

 

 

 

 

 

 

 

a. Opacity

1

2

1

2

2

1

1

1

2

 

b. Area Involved

1

2

1

2

2

1

1

1

2

 

II. Iris

 

 

 

 

 

 

 

 

 

 

a. Evaluation

0

2

1

1

1

0

1

0

1

 

III. Conjunctiva

 

 

 

 

 

 

 

 

 

 

a. Hyperemia

1

3

2

3

3

3

2

2

2

 

b. Chemosis

1

3

1

3

3

3

2

1

2

 

C. Discharge

2

3

2

3

3

3

2

2

2

 

Total Score

13

48

20

43

43

23

22

15

37

29.33

 

 

 

 

 

 

 

 

 

 

 

 

48

I. Cornea

 

 

 

 

 

 

 

 

 

 

a. Opacity

0

2

0

3

1

1

1

0

1

 

b. Area Involved

0

2

0

2

1

1

1

0

1

 

II. Iris

 

 

 

 

 

 

 

 

 

 

a. Evaluation

0

1

0

1

0

1

0

0

1

 

III. Conjunctiva

 

 

 

 

 

 

 

 

 

 

a. Hyperemia

0

2

1

2

1

1

1

1

1

 

b. Chemosis

0

1

1

2

0

1

0

0

0

 

C. Discharge

1

2

1

3

1

2

1

1

2

 

Total Score

2

35

6

39

9

18

9

4

16

15.33

 

 

 

 

 

 

 

 

 

 

 

 

72

I. Cornea

 

 

 

 

 

 

 

 

 

 

a. Opacity

0

2

0

2

0

0

0

0

1

 

b. Area Involved

0

2

0

2

0

0

0

0

1

 

II. Iris

 

 

 

 

 

 

 

 

 

 

a. Evaluation

0

0

0

1

0

0

0

0

1

 

III. Conjunctiva

 

 

 

 

 

 

 

 

 

 

a. Hyperemia

0

2

0

2

0

1

0

0

1

 

b. Chemosis

0

0

0

2

0

0

0

0

0

 

C. Discharge

0

2

0

3

0

1

0

0

2

 

Total Score

0

28

0

39

0

4

0

0

16

9.66

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The aim of this study was to investigate possible reversible or irreversible irritancy by the test substance following a single application into the eyes of rabbits.
Methods and investigations were performed in conformance with the OECD Guideline 405. An irritation was observed.
Executive summary:

The aim of this study was to investigate possible reversible or irreversible irritancy by the test substance following a single application into the eyes of rabbits. The procedure followed in principle the standard that was later described in the OECD Technical Guideline 405. For the test,0.1 mL ethyl 2-cyanoacrylate was applied into the conjunctival sac of the right eyes of each of the 9 rabbits. The duration of the exposure was 72 hours. The treated rabbit eyes were investigated after 24, 48 and 72 hours after instillation of ethyl 2-cyanoacrylate. The group mean score at 24 hours was 29.33. the group mean score at 48 and 72 hours were 15.33 and 9.66 respectively. An irritation was observed.