Registration Dossier
Registration Dossier
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EC number: 700-840-4 | CAS number: 160583-22-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Ethyl 2-cyanoacrylate
- EC Number:
- 230-391-5
- EC Name:
- Ethyl 2-cyanoacrylate
- Cas Number:
- 7085-85-0
- IUPAC Name:
- ethyl 2-cyanoacrylate
- Reference substance name:
- [TN]Product 495[/TN][SPEC][/SPEC][AM][/AM]
- IUPAC Name:
- [TN]Product 495[/TN][SPEC][/SPEC][AM][/AM]
- Details on test material:
- - Name of test material: Depend, IS 04E
- Trade name: Product 495
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system 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.
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