Mecrilate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

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:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Code of Federal Regulations § 191.12 (1973)

GLP compliance:

no

Remarks:

prior to GLP

Test material

Test material information

Constituent 1

Reference substance name:

Mecrilate

EC Number:

205-275-2

EC Name:

Mecrilate

Cas Number:

137-05-3

Molecular formula:

C5H5NO2

IUPAC Name:

methyl 2-cyanoprop-2-enoate

Details on test material:

- Name(s): Methyl 2-cyanoacrylate, Mecrilate, 2-Propenoic acid, 2-cyano-, methyl ester
- CAS 137-05-3
- Purity: 88.8 %

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL

Observation period (in vivo):

7 d

Number of animals or in vitro replicates:

6

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24 h

Score:

1.33

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

48 h

Score:

1.25

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

72 h

Score:

1.17

Results 4

Irritation parameter:

iris score

Basis:

mean

Time point:

24 h

Score:

1.33

Results 5

Irritation parameter:

iris score

Basis:

mean

Time point:

48 h

Score:

0.5

Results 6

Irritation parameter:

iris score

Basis:

mean

Time point:

72 h

Score:

0.67

Results 7

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24 h

Score:

2.33

Results 8

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

48 h

Score:

2.25

Results 9

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

72 h

Score:

1.67

Results 10

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24 h

Score:

1.33

Results 11

Irritation parameter:

chemosis score

Basis:

mean

Time point:

48 h

Score:

1

Results 12

Irritation parameter:

chemosis score

Basis:

mean

Time point:

72 h

Score:

0.83

Results 13

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

33

Remarks on result:

other: 3 rabbits only due to bonded lids

Results 14

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Score:

28.2

Remarks on result:

other: 4 rabbits only due to bonded lids

Results 15

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Score:

32.5

Results 16

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Score:

27.5

Any other information on results incl. tables

RESULTS

The individual scores for each rabbit in this study are presented in TABLE 1. The group mean score at 24 hours was 33.0. The group mean scores at 48 and 72 hours and 7 days were 28.2, 32.5 and 27.5 respectively. According to the Draize evaluation, 150 Super-Bonder would be considered an irritant to the eye.

TABLE 1

time	parameter	1	2	3	4	5	6	mean
24 h	cornea - opacity	*	0	3	*	1	*	1.33
24 h	cornea - area	*	0	3	*	1	*	1.33
24 h	iris	*	0	3	*	1	*	1.33
24 h	conjunctiva - hyperemia	*	2	2	*	3	*	2.33
24 h	conjunctiva - chemosis	*	1	1	*	2	*	1.33
24 h	conjunctiva - discharge	*	0	3	*	3	*	2.00
48 h	cornea - opacity	0	0	3	*	2	*	1.25
48 h	cornea - area	0	0	3	*	2	*	1.25
48 h	iris	0	0	1	*	1	*	0.50
48 h	conjunctiva - hyperemia	3	1	2	*	3	*	2.25
48 h	conjunctiva - chemosis	1	0	1	*	2	*	1.00
48 h	conjunctiva - discharge	2	1	1	*	2	*	1.50
72 h	cornea - opacity	0	0	0	3	0	4	1.17
72 h	cornea - area	0	0	0	3	0	4	1.17
72 h	iris	0	0	0	2	0	2	0.67
72 h	conjunctiva - hyperemia	1	1	2	2	2	2	1.67
72 h	conjunctiva - chemosis	0	0	0	3	0	2	0.83
72 h	conjunctiva - discharge	1	1	1	3	1	3	1.67
7 d	cornea - opacity	0	0	0	4	0	3	1.17
7 d	cornea - area	0	0	0	4	0	3	1.17
7 d	iris	0	0	0	2	0	2	0.67
7 d	conjunctiva - hyperemia	0	0	0	1	0	2	0.50
7 d	conjunctiva - chemosis	0	0	0	3	0	2	0.83
7 d	conjunctiva - discharge	0	0	0	1	0	1	0.33

1 -3 unwashed, 4 -5 2 -sec. rinse

* lids bonded shut

Remark:

The initial reaction of each rabbit as the compound was introduced into the eye was one of severe irritation characterized by a vocalization of pain. In almost all instances, the lids of each rabbit were bonded shut but only those which were more easily forced open were gently pried open to make the readings. No attempt was made to forcibly pry or cut open the lids which were strongly bonded so that any unnecessary damage to the eye was avoided. In all cases where the eye was severely irritated, a white pus-like discharge was observed. Photographs of the described observations were taken at various intervals during the study.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Remarks:

Criteria used for interpretation of results: Draize

Conclusions:

According to the Draize evaluation, the test material would be considered an irritant to the eye.