Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
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 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material: Depend, IS 04E
Trade name: Product 495

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: the body weight ranged from 206 to 246 g
- Fasting period before study: 18 hours

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
No. of animals per sex per dose:
6 male albino rats
Control animals:
no
Details on study design:
The test compound was administered by oral intubation to 1 group of 6 male albino rats fasted for 18 hours prior to dosing. The animals were observed during the day of dosing and daily thereafter for 14 days. Decents during the study were examined for gross lession.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
One rat died on the fourth day.
Gross pathology:
Hemorrhagic lungs. solid mass in stomach, not adhered to stomach wall but too large to pass through pyloric valve. cardic portion of stomach distended. food in intestines as in a normal rat. One rat had dilated intestinal blood vessels.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 of ethyl-2-cyanoacrylate is estimated to be higher than 5000 mg/kg body weight in rats for a single dose.
Therefore the test substance ethyl-2-cyanoacrylate is practically nontoxic according to the EC-guideline 93/21.