Registration Dossier

Administrative data

Description of key information

A study on repeated toxicity is waived due to high reactivity of 2-phenylethyl cyanoacrylate which makes testing not feasable. On contact with moisture, 2-phenylethyl cyanoacrylate polymerizes immediately.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

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, so polymerization will occur during administration. Due to this high reactivity the determination of a NOAEL or LOAEL is not possible as 2-phenylethyl cyanoacrylate is not bioavailable after administration.

 

Thus, in accordance with annex XI section 2 of Regulation (EC) No 1907/2006 testing of 2-phenylethyl cyanoacrylate on repeated dose toxicity is waived.

Justification for classification or non-classification

No sub-acute or chronic toxicity is expected since bioavailability of 2 -phenylethyl cyanoacrylate is unlikely due to its high reactivity.