Mecrilate

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 § 191.11 (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

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:

no

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

24 h

Observation period:

72 h

Number of animals:

6

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Remarks on result:

not determinable

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Remarks on result:

not determinable

Results 3

Irritation parameter:

erythema score

Remarks:

Erythema & Eschar

Basis:

mean

Remarks:

intact skin

Time point:

24 h

Score:

1.17

Max. score:

2

Reversibility:

not fully reversible within: 72 h

Results 4

Irritation parameter:

erythema score

Remarks:

Erythema & Eschar

Basis:

mean

Remarks:

intact skin

Time point:

72 h

Score:

0.33

Max. score:

1

Reversibility:

no data

Results 5

Irritation parameter:

erythema score

Remarks:

Erythema & Eschar

Basis:

mean

Remarks:

abraded skin

Time point:

24 h

Score:

2.17

Max. score:

3

Reversibility:

not fully reversible within: 72 h

Results 6

Irritation parameter:

erythema score

Remarks:

Erythema & Eschar

Basis:

mean

Remarks:

abraded skin

Time point:

72 h

Score:

4

Max. score:

4

Reversibility:

no data

Results 7

Irritation parameter:

edema score

Basis:

mean

Remarks:

intact and abraded skin

Time point:

other: 24/72 h

Score:

0

Max. score:

0

Remarks on result:

other: no edema observed

Any other information on results incl. tables

RESULTS

The individual scores with regard to Erythema and Eschar formation for each rabbit in this study are presented in TABLE 1. No edema formation has been observed throughout the study.

Mean scores are totaled and averaged to provide an arbitrary Primary Irritation Index (PII) . For the sample identified as 150 Super-Bonder , the PlI was found to be 1.92. According to the evaluation of Draize, the 150 Super- Bonder would be considered an irritant to the skin.

TABLE 1 (Erythema & Eschar)

Preparation	time of observation	1	2	3	4	5	6
intact skin	24 h	2	1	1	1	1	1
intact skin	72 h	1	0	1	0	0	0
abraded skin	24 h	3	2	3	2	1	2
abraded skin	72 h	4	4	4	4	4	4

Remark:

After the 24 h exposure period, the test pIasters were bonded to the skin and could not be removed without damage to the skin. The skin immediately surrounding the bandages appeared hard and irritated and at 72 h slight eschar formation was observed.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

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