Registration Dossier

Administrative data

Endpoint:
sediment toxicity: long-term
Data waiving:
study technically not feasible
Justification for data waiving:
other:
Justification for type of information:
Justification for data waiving
Cyanoacrylate type instant glues are highly reactive in contact with moisture and lead to very poorly soluble polymerisation products.
The substance ethyl 2-cyanoacrylate (EC 230-391-5) is a representative of the group of cyanoacrylate based reactive glues. Colloquially this type of glues is named ‘instant glues’ indicating that they cure within seconds to minutes. The polymerisation reaction starts with the reaction of traces of hydroxide ions with the activated double bond and leads to insoluble polymers within very short periods of time. The concentration of hydroxide ions originating from the autoprotolysis of ambient moisture or adsorbed water on surfaces (COH- = 10-7 mol/L) is sufficient to start the polymerisation reaction.
Waiving justification based on Annex XI, REACH Regulation
According Annex XI of the REACH Regulation a test can be waived for technical reasons if the test substance is e.g.
• Highly volatile
• Highly active or unstable
• Mixing of the substance with water may cause danger of fire or explosion
• The radio-labelling of the substance required in certain studies may not be possible
The typical application of instant glues is a dropwise application with instantaneous polymerisation in place. Thus, a significant release to the aquatic environment including sediment and to soil is not to be anticipated. In all tests with contact to moisture the registered substance ethyl 2-cyanoacrylate (EC 230-391-5) is highly active or unstable with regard to the monomer. See chapter 5.6 Additional information on environmental fate and behaviour with information on the polymerisation reaction rate in contact with moisture. The monomer concentration after polymerisation in contact with water is very low and only traces are detectable (see Physical & Chemical Properties, Water Solubility) Therefore the reason to waive studies with unavoidable contact to moisture are fulfilled according Annex XI or REACH regulation. The reaction product is a polymer which is not yet to be registered.

Conclusion
Due to the chemical properties of the registered substance ethyl 2-cyanoacrylate (EC 230-391-5) and based on justification requirements for waiving defined in Annex IX REACH Regulation chapter 9.2 and Annex XI REACH Regulation chapter 2, simulation tests for biodegradation in surface water, soil and sediments are not possible and not necessary.

Data source

Materials and methods

Results and discussion

Any other information on results incl. tables

Study technically not feasible → Tests in aqueous or moist media with ethyl 2-cyanoacrylate with the intent to determine effective concentrations or no effect concentrations cannot be performed due to technical reasons based on the chemical properties of the monomer. In presence of moisture ethyl 2-cyanoacrylate polymerises within seconds (inherent property of ethyl 2-cyanoacrylate based instant glues). Thus, very low determined monomer concentrations in water or moist media represent a non-steady state situation from which a defined effective concentration cannot be derived.

Applicant's summary and conclusion

Conclusions:
Tests in aqueous or moist media with ethyl 2-cyanoacrylate with the intent to determine effective concentrations or no effect concentrations cannot be performed due to technical reasons based on the chemical properties of the monomer.
Executive summary:

Tests in aqueous or moist media with ethyl 2-cyanoacrylate with the intent to determine effective concentrations or no effect concentrations cannot be performed due to technical reasons based on the chemical properties of the monomer. In presence of moisture ethyl 2-cyanoacrylate polymerises within seconds (inherent property of ethyl 2-cyanoacrylate based instant glues). Thus, very low determined monomer concentrations in water or moist media represent a non-steady state situation from which a defined effective concentration cannot be derived.