Registration Dossier

Administrative data

Description of key information

Study is technically not feasible as 2-phenylethyl cyanoacrylate polymerizes within seconds on contact with moisture.

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-phenylethyl 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-phenylethyl cyanoacrylate on acute toxicity is waived.

 

2-Phenylethyl 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 only 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 -phenylethyl 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 -Phenylethyl 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 -phenylethyl cyanoacrylate will also not demonstrate acute toxicity and is thus not classified.