Ethyl 2-cyanoacrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

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

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped, 6 areas abraded, 6 areas intact skin

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 g ethyl cyanoacrylate

Duration of treatment / exposure:

24 hours

Observation period:

The test areas were scored for dermal irritation immediately following the 24-hour exposure period and again at 72 hours.

Number of animals:

six male rabbits

Details on study design:

The skin on the dorsal surface of six male albino rabbits of theNew Zealand strain was shaved free of hair with an electric clipper. Twelve dorsal test areas were utilized; six of the dorsal test areas were abraded down to, but not through, the dermis, using a hypodermic needle. The reamining test areas were left intact. Standard patch test plasters (1" x 1" gauze pad) were saturated with 0,5g ethyl cyanoacrylat and applied to the dermal test areas. The patch test plasters were left in place for 24 hours. The test areas were scored for dermal irritation immediately following in the 24-hour expossure period and again at 72 hours.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Score:

0.87

Results 2

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

mean

Time point:

24 h

Score:

1.5

Results 3

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Results 4

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

mean

Time point:

72 h

Score:

0.16

Reversibility:

fully reversible

Results 5

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

mean

Time point:

24 h

Score:

1.5

Results 6

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Results 7

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

mean

Time point:

72 h

Score:

0.16

Reversibility:

fully reversible

Any other information on results incl. tables

	Time of Observation [Hours]	Response Rabbit No.						Mean Score
		1	2	3	4	5	6
Erythema & Eschar:
Intact Skin	24	2	2	1	1	1	2	1.50
Intact Skin	72	0	0	0	0	0	1	0.16
Abraded Skin	24	2	2	1	1	1	2	1.50
Abraded Skin	72	0	1	0	0	0	1	0.33
						Subtotal:		3.49
Edema Formation:
Intact Skin	24	2	2	1	1	1	2	1.50
Intact Skin	72	0	0	0	0	0	1	0.16
Abraded Skin	24	2	2	1	1	1	2	1.50
Abraded Skin	72	0	1	0	0	0	1	0.33
						Subtotal:		3.49
						Total:		6.98

Applicant's summary and conclusion

Interpretation of results:

other: slightly irritating

Conclusions:

The aim of this study was to investigate possible reversible or irreversible irritancy and/or corrosion by the test substance following a single application to the intact skin of rabbits.
Methods and investigations were performed in conformance with the OECD Guideline 404. A slight skin irritation was observed.

Executive summary:

The aim of this study was to investigate possible reversible or irreversible irritancy and/or corrosion by the test substance following a single application to the intact skin of rabbits. Methods and investigations were performed were similar to the procedure described in the OECD Guideline 404. An amount of 0.5 g ethyl-2-cyanoacrylate was applied to intact skin areas and to abraded skin areas (covered with an gauze bandage) of each of 6 rabbits. The duration of the exposure was 24 hours.The skin was examined directly after the 24 -hour exposure and 72 hours after patch removal. The primary dermal irritation index (PDII) was found to be 0.87 (includes scores for intact and abraded skin).

A slight skin irritation was observed.