Mecrilate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 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

Details on test material:

- Name of test material: 04E Depend
- substance name: ethyl-2-cyanoacrylate
- CAS: 7085-85-0
- Description: clear, colorless glue
- purity: 95%

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: from 2034 to 2481 g
- Housing: cages
- Diet: ad libitum
- Water: ad libitum

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 was applied under rubber dental damming held in place with adhesive tape.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

4 males

Control animals:

no

Details on study design:

The rabbits were clipped free of dorsal hair with an electric clipper. The test material was 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 effect 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 sskin; 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.
In conclusion, the test substance ethyl-2-cyanoacrylate is practically nontoxic.

Executive summary:

In an acute dermal study similar to OECD TG 402, a limit dose of 2000 mg/kg bw ethyl 2 -cyanoacrylate was administered once on the dorsal free clipped skin of four male albino rabbits. The animals were observed during the day of dosing and daily thereafter for 14 days. On day 14, all animals were sacrificed and necropsied. No mortality was observed during the study. A large open sore was observed after 14 days of exposre. The dermal LD50 of ethyl 2 -cyanoacrylate was estimated to be higher than 2000 mg/kg bw in rabbits after single exposure.