2-methoxyethyl 2-cyanoacrylate

Endpoint summary

Description of key information

Test not performed because 2-methoxyethyl 2-cyanoacrylate is highly reactive to water resulting in fast polymerization process (in seconds) thus the nature of the substance does not allow to be tested for the endpoint Acute Toxicity (Annex XI, section 2). As it is described in the Guidance on information requirements and chemical safety assessment Chapter R.5: Adaptation of information requirements chapter (R.5.2.2 Testing is technically not possible (page 28)) the waiver is herewith justified. Thus, our waiver is based on following argumentation:  1. testing is technically not possible and 2. the exposure to the 2-methoxyethyl 2-cyanoacrylate monomer plays a minor role or is unlikely.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Stability testing demonstrated that 2 -methoxyethyl 2-cyanoacrylate is a reactive molecule which polymerizes immediately on contact with moisture. Due to the compound’s high reactivity, a study on acute toxicity is technically not feasible, i.e. the study will not result in any information on potential adverse effects exerted by the monomer.

 

Thus, in accordance with Annex XI Section 2 of Regulation (EC) No 1907/2006 testing of 2 -methoxyethyl 2-cyanoacrylate on acute toxicity is waived.

 

2 -methoxyethyl 2-cyanoacrylate shares its high reactivity with other cyanoacrylates, and its reaction mechanism of polymerization is identical to that of e.g. ethyl 2-cyanoacrylate. A study on acute oral toxicity in rats for ethyl 2-cyanoacrylate resulted in one dead animal with the polymerized compound found residing as a solid mass in the rat's stomach, being the most probable cause of death. This observation underlines that the polymeric form of ethyl 2-cyanoacrylate instead of the monomers could be assessed with this study. Based on this, the LD50 for ethyl 2-cyanoacrylate was indicated to be above 5000 mg/kg bw. Similar study results are expected for 2 -methoxyethyl 2-cyanoacrylate, therefore additional testing of this compound in an acute oral toxicity study appears to be scientifically unjustified.

 

Justification for classification or non-classification

2 -Methoxyethyl 2-cyanoacrylate will polymerize quickly in contact with water resulting in negligible bioavailability of the monomer. Based on the fact that for the similar compound 2-ethyl cyanoacrylate which shows the same mechanism of polymerisation, an oral LD50 of > 5000 mg/kg body weight and a dermal LD50 of > 2000 mg/kg has been found, it is concluded that 2 -methoxyethyl 2-cyanoacrylate will also not demonstrate acute toxicity and is thus not classified.