Registration Dossier

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:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: 04E Depend
- Description: clear, colorless glue
- 97% ethyl-2cyanoacrylate

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals 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 systemictoxicity.
Observations for mortality and signs of effect were made for 14 days, and the survivors were sacridiced and examined for gross pathology.

Results and discussion

Effect levels
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:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.