2-methoxyethyl 2-cyanoacrylate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting 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 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

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:

- Name of test material: 04E Depend
- Description: clear, colorless glue
- 97% ethyl 2-cyanoacrylate

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: weight ranged from 2034 to 2481 g
- Housing: cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The rabbits were clipped free of dorsal hair with an electric clipper. The test material were applied under rubber dental damming held in place with adhesive tape.

Duration of exposure:

24 hours

Doses:

no data

No. of animals per sex per dose:

4 male albino rabbits of the New Zealand strain

Control animals:

no

Details on study design:

The rabbits were clipped free of dorsal hair with an electric clipper. The test material were applied under rubber dental damming held in place with adhesive tape for 24 hours. During this time, the animals were observed for signs of systemic toxicity.
Observations for mortality and signs of effects were made for 14 days, and the survivors were sacrificed and examined for gross pathology.

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality

Gross pathology:

.

Other findings:

Bandages and wrapping were initially bonded to skin; however, after 14 days, bandages were easily peeled off exposing a large open sore at the site of application.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 of ethyl-2-cyanoacrylate is estimated to be higher than 2000 mg/kg body weight in rabbits for a single dose.
Therefore the test substance ethyl-2-cyanoacrylate is practically nontoxic according to the EC-guideline 93/21.

Executive summary:

Aim of the study :

It was the aim of the study to investigate acute toxic effects of the test substance after a single dermal administration.

Methods:

The method was similar to the OECD-Guideline 402, "Acute Dermal Toxicity".

Administration:

Ethyl-2-cyanoacrylate was administered once dermal on the dorasal free clipped skin of 4 male albino rabbits.

Investigations:

The animals were observed during the day of dosing and daily thereafter for 14 days.

Necropsy: all animals were sacrificed and necropsied 14 days p.a.

Results

Mortality:

No mortality was observed.

Findings:

Bandages and wrapping were initially bonded to sskin; however, after 14 days, bandages were easily peeled off exposing a large open sore at the site of application.

The dermal LD50 of ethyl-2-cyanoacrylate is estimated to be higher than 2000 mg/kg body weight in rabbits for a single dose.