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chronic toxicity: dermal
Data waiving:
study technically not feasible
Justification for data waiving:
Justification for type of information:
Ethyl 2-cyanoacrylate can be considered as highly active, as it rapidly polymerises in the presence of moisture. Study data demonstrates that this polymerisation takes at maximum a few minutes to be completed, depending on the specific conditions of reaction (see IUCLID 7.1.1. Basic toxikokinetics, study on polymerisation speed). Rapid polymerisation results in different technical issues that make testing of the material in a chronic dermal study not feasible. First of all, polymerisation on the skin and the resulting polymeric mass on the skin is challenging in the view that multiple application are required in a repeated dose study. Furthermore, after polymerisation, the skin is exposed to the polymer or its degradation products but not to ethyl 2-cyanoacrylate anymore. Due to this reactivity of ethyl 2-cyanoacrylate upon contact to moisture on the animal skin, testing of this material in a chronic dermal study is technically not feasible and would not inform about an intrinsic hazard of ethyl 2-cyanoacrylate. Hence, this study is waived according to REACH Annex XI, section 2. This is in accordance with the Guidance on information requirements and chemical safety assessment (chapter R.5, version 2.1 of December 2011), in which in chapter R.5.2.2 the example of a substance having a high reactivity with water is explicitly mentioned as a case where testing might not be feasible for technical reasons.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion