2-methoxyethyl 2-cyanoacrylate

Endpoint summary

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 in exogenous reactions. Therefore, is technically not possible to assess the skin sensitizing potential of the isolated 2-methoxyethyl 2-cyanoacrylate monomer as it can be expected that during the test procedure polymerisation is triggered by humidity of the ambient air or the superficial skin layers, respectively. This reaction is faster than the penetration of monomers through skin, making it unlikely to expose cells involved in a sensitization reaction to the monomeric substance.

However, allergic reactions towards cyanoacrylate adhesives are occasionally described in the literature. These case reports often lack a clear description which substance caused the observed reactions. Both the monomers and degradation products of the polymer, including formaldehyde, are discussed to be causative to the 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. Considering the widespread industrial and domestic use of cyanoacrylates, these case reports are rather seldom and do not reflect the general sensitizing properties of cyanoacrylates.

 

In order to evaluate the potential relevance of monomeric residues and impurities in a cyanoacrylate polymer as well as of degradation products or additives which are added to the product formulation, a study was performed with 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. A similar study with the same result was also performed with n-butyl 2-cyanoacrylat confirming the low extractability of any skin sensitizing side component or residue from the polymer. Such results can be assumed for other cyanoacrylates like 2 -methoxyethyl 2 -cyanoacrylate as well.

Study is technically not feasible as 2-methoxyethyl 2-cyanoacrylate polymerizes on contact with moisture.Thus, in accordance with annex XI section 2 of Regulation (EC) No 1907/2006 testing of 2-methoxyethyl 2-cyanoacrylate on skin senistization is waived.

Justification for classification or non-classification

2 -Methoxyethyl 2-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 does not require classification.