Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

2-Phenylethyl cyanoacrylate polymerizes immediately on contact with moisture, hence, any potential genetic toxicity of the monomer cannot be assessed.

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

Even though assessing the potential genetic toxicity of monomers of fast polymerizing 2 -cyanoacrylates is generally difficult, several studies on mutagenicity were performed with different homologues which primarily reflect the characteristics of the resulting polymers.

Ames tests were perfomed for ethyl, allyl, butyl, and iso-butyl 2-cyanoacrylates and demonstrated no mutagenicity under the applied test conditions. Only for methyl 2-cyanoacrylate an indication of a mutagenic potential in one strain (TA 100) was found. The other strains did not indicate mutagenicity, so the result of the various Ames tests can be considered as ambiguous for methyl 2 -cyanoacrylate.

Ethyl 2-cyanoacrylate was tested in an in vitro chromosome aberration study and in an mammalien cell gene mutation test with negative results. Based on the similarity in structure and reactivity it is expected that the observations of missing genetic toxicity also reflect the characteristics of 2-phenylethyl cyanoacrylate.



Short description of key information:
Several studies on genetic toxicity of different 2-cyanoacrylate homologues yielded negative result. It is feasible to assume that the test results represent the effect of the corresponding cyanoacrylate polymers as the monomers polymerize immediately on contact with moisture and are not accessible in these tests. Since 2-phenylethyl cyanoacrylate polymerizes immediatly on contact with moisture too, an additional study on genetic toxicity for 2-phenylethyl cyanoacrylate is waived.

Endpoint Conclusion: No study available

Justification for classification or non-classification

In general, 2-cyanoacrylates are a family of fast-reacting adhesives. Cyanoacrylate monomers rapidly polymerize in the presence of water to form long, strong chains. As a result, the 2-phenylethyl cyanoacrylate monomer is not considered to show genetic toxicity which is in line with studies on genetic toxicity on other cyanoacrylate homologues.

It is thus concluded that 2-phenylethyl cyanoacrylate can be considered non-genotoxic, resulting in no classification.