Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

In general, 2 -cyanoacrylates react rapidly in contact with water to form polymers (within seconds) in exogenous reactions. It is thus technically not possible to assess the skin sensitizing potential of the isolated 2-phenylethyl cyanoacrylate monomer. It can be expected that during the test procedure the monomer reacts with the humidity of the air and on the skin to form the polymer. This reaction is much faster than a penetration through skin, making it practically impossible to expose cells involved in a sensitization reaction to the monomeric substance.

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

Allergic reactions towards cyanoacrylate adhesives are occasionally described in literature. Case reports often lack a clear description which substance caused the observed reactions. Some authors argue that the monomer might be of relevance, others argue that degradation products including formaldehyde could have caused reactions. As the full composition of the commercial products have not been described in most of the case reports, it could not be clarified which chemical substances were present and contributed to the adverse skin effects.

In order to evaluate the potential relevance of monomeric residues in a cyanoacrylate polymer as well as of degradation products or additives which are added to the product formulation, a study was performed with the homologue 1-methylheptyl 2-cyanoacrylate. Water-based and lipid-based extracts of the polymerized adhesive formed from 1-methylheptyl 2-cyanoacrylate have been made (in physiological saline and cotton seed oil) according to standard procedures for medicinal products, and were investigated in the Magnussen-Kligman Maximization test. No potential for skin sensitization was observed in this test compared with the control.

Migrated from Short description of key information:
Study is technically not feasible as 2-phenylethyl cyanoacrylate polymerizes within seconds on contact with moisture.

Justification for classification or non-classification

2 -Phenylethyl cyanoacrylate binds instantaneously to the skin's surface and polymerizes. The polymerized material is not able to penetrate into the epidermis. Hence, the substance is not considered to be a skin sensitizer and needs no classification.