Allyl 2-cyanoacrylate

Endpoint summary

Description of key information

REACH_LD50 > 5000 mg/kg bw | rat (male) | - | Ethylcyanoacrylate #Analogy#

REACH_LD50 > 2000 mg/kg bw | rat (female) | Acute toxicity: oral allyl 2-cyanoacrylate (extract)#key study#

All available data on ethyl 2-cyanoacrylate (ECA) indicate an absence of lethal effects after application of doses >2000 mg/kg body weight via the oral or dermal route.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

see additional information

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

See additional information

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Allyl 2-cyanoacrylate and 2-ethyl cyanoacrylate are structural analogues and share the reactive cyanoacrylate function. The chain length of the alcohol moiety in allyl 2-cyanoacrylate is only slightly different compared to 2-ethyl cyanoacrylate. Both 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. Based on these physico-chemical behaviour conducting an experimental test for assessing the acute oral toxicity of the monomer is technically not meaningful.

The attempted tests already demonstrated that a standard test was technically not feasible. Preliminary tests in aqueous media with allyl 2-cyanoacrylate to determine a LD50 value cannot be performed due to technical reasons based on the chemical properties of the monomer. In presence of moisture allyl 2-cyanoacrylate polymerizes fast (inherent property of instant glues). The monomer was found polymerized in the stomach when administered orally.

Thus, it is concluded that for allyl 2-cyanoacrylate on acute oral toxicity can be drawn from the structural analogue 2-ethyl cyanoacrylate. It was the aim of the study with 2-ethylcyanoacrylate to investigate acute toxic effects of the test substance after a single oral administration.

 

Methods

The method was similar to the OECD-Guideline 423, "Acute Oral Toxicity - Acute Toxic Class Method".

Administration: Ethyl-2-cyanoacrylate was administered once orally by stomach intubation to 6 male albino rats (5000 mg/kg).

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: One mortality was observed.

Necropsy findings: 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.

The LD50 of ethyl-2-cyanoacrylate is estimated to be higher than 5000 mg/kg body weight in rats for a single dose.

 

Moreover, in a test according to ISO 10993-11 (1993), Biological Evaluation of Medical Devices Part 11: Test for Systemic Toxicity, it was observed that extracts of the cured, polymerized material did not induce a significantly greater biological reaction than the control articles, when tested in Albino Swiss mice after intraveneous or intraperitoneal injection.

 

Based on the overall weight of evidence, allyl 2-cyanoacrylate is of low acute toxicity after oral exposure.

Justification for classification or non-classification

Based on available information allyl 2-cyanoacrylate is of low acute toxicity after oral exposure. No classification is required.