Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
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 oral 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 and any effect would originate from the resulting polymer or degradation products thereof.

 

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

 


Short description of key information:
A study on toxicity to reproduction is waived due to high reactivity of 2-phenylethyl cyanoacrylate which makes testing not feasible. On contact with moisture, 2-phenylethyl cyanoacrylate polymerizes immediately.

Effects on developmental toxicity

Description of key information
A study on developmental 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.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
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 oral administration. Due to this high reactivity the determination of a NOAEL or LOAEL is not possible as 2-phenylethyl cyanoacrylate is not bioavailabe after administration and any effect would originate from the resulting polymer or degradation products thereof.

 

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

 

Justification for classification or non-classification

No developmental toxicity or toxicity to reproduction is expected as bioavailability of 2 -phenylethyl cyanoacrylate is unlikely due to its high reactivity.