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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
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

Principles of method if other than guideline:
Comparable to guideline study with acceptable restrictions (no GLP)
GLP compliance:
no
Limit test:
yes

Test material

Constituent 1
Chemical structure
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
Constituent 2
Reference substance name:
[TN]ethyl 2-cyanoacrylate[/TN][SPEC][/SPEC][AM][/AM]
IUPAC Name:
[TN]ethyl 2-cyanoacrylate[/TN][SPEC][/SPEC][AM][/AM]
Details on test material:
- Name of test material: Depend, IS 04E, Trade name: Product 495
- 97% ethyl-2 cyanoacyrlate
Specific details on test material used for the study:
1-Methylheptyl cyanoacrylate is a structural analogue to 2-ethyl cyanoacrylate. Both substances share the reactive cyanoacrylate function. The chain length of the alcohol moiety in 1-methylheptyl cyanoacrylate is increased compared to 2-ethyl cyanoacrylate. The mentioned cyanoacrylates are very reactive monomers and polymerize immediately (within 30-60 sec) in the presence of moisture based on the same reaction mechanism. The polymerized materials have a high molecular mass and are not able to penetrate through skin or intestinal wall resulting in low bioavailability.

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)
Doses:
5000 mg/kg
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. All animals were sacrified and necropsied 14 days p.a.. Decents during the study were examined for gross lession.

Results and discussion

Effect levels
Key result
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:
The pathological examination showed hemorrhagic lungs, a solid mass in stomach, not adhered to stomach wall but too large to pass through pyloric valve. Cardiac 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.
Executive summary:

It was the aim of the study with 2-ethylcyanoacrylate to investigate acute toxic effects of the test substance after a single oral administration. Due to structural similarities and a comparable reaction mechanism with water resulting in a polymer, read-across of the result of this study to 1 -methylheptyl cyanoacrylate is justified.

1-Methylheptyl cyanoacrylate will polymerize quickly in contact with water resulting in low bioavailability. Based on the fact that the structural analogue 2-ethyl cyanoacrylate has shown a LD50 of > 5000 mg/kg body weight in an experimental investigation (oral, rat) and the reaction mechanism is the same for 1-methylheptyl cyanoacrylate, it is concluded that 1-methylheptyl cyanoacrylate will also not be of acute oral toxicity and is thus not classified.

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