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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
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 1-methylheptyl 2-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 an allergic reaction to the monomeric substance. Technically feasible and of relevance are possible monomeric residues in the cyanoacrylate polymer as well as additives, which are added to the product formulation, or potential degradation products. Therefore, 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. They were investigated in the Magnussen-Kligman Maximization test. No potential for skin sensitization was observed in this test compared with the control.

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 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.

Therefore, for assessing the skin sensitizing potential of the substance 1-methylheptyl 2-cyanoacrylate the test was conducted with the polymerized commercial formulation. By using extracts, the leakage of residual monomers and by-products has been covered. The results of the study indicate that 1-methylheptyl 2-cyanoacrylate is not sensitizing to the skin.

Migrated from Short description of key information:
REACH_not sensitising | guinea pig│ISO 10993-10 (Kligman Maximization test) | [TN]1-methylheptyl cyanoacrylate[/TN][SPEC][/SPEC][AM]94.5%[/AM]#key study#

Justification for classification or non-classification

Based on the investigation of two extracts of the polymerized 1-methylheptyl 2-cyanoacrylate in the skin sensitization test according to Magnussen-Kligmann, it was concluded that this substance is not considered to be a skin sensitizer and thus needs no classification.