Ethyl 2-cyanoacrylate

Eye irritation

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

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl 2-cyanoacrylate

EC Number:

230-391-5

EC Name:

Ethyl 2-cyanoacrylate

Cas Number:

7085-85-0

Molecular formula:

C6H7NO2

IUPAC Name:

ethyl 2-cyanoacrylate

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

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

29.33

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

48 h

Score:

15.33

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Score:

9.66

Reversibility:

not specified

Remarks:

72h observation period

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24 h

Score:

1.44

Results 5

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

48 h

Score:

1

Results 6

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

72 h

Score:

0.56

Reversibility:

not specified

Remarks:

72h observation period

Results 7

Irritation parameter:

iris score

Basis:

mean

Time point:

24 h

Score:

0.78

Results 8

Irritation parameter:

iris score

Basis:

mean

Time point:

48 h

Score:

0.44

Results 9

Irritation parameter:

iris score

Basis:

mean

Time point:

72 h

Score:

0.22

Reversibility:

not specified

Remarks:

72h observation period

Results 10

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24 h

Score:

2.33

Results 11

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

48 h

Score:

1.11

Results 12

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

72 h

Score:

0.66

Reversibility:

not specified

Remarks:

72h observation period

Results 13

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24 h

Score:

2.11

Results 14

Irritation parameter:

chemosis score

Basis:

mean

Time point:

48 h

Score:

0.56

Results 15

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.