Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Data waiving:
study technically not feasible
Justification for data waiving:
other:
Justification for type of information:
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 VII, REACH Regulation
According Annex VII of the REACH Regulation a test can be waived if the test substance is e.g.
Chapter 9.1.1 Short-term toxicity testing on invertebrates
• there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes
Chapter 9.1.2 Growth inhibition study aquatic plants
• The study does not need to be conducted if there are mitigating factors indicating that aquatic toxicity is unlikely to occur for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes.
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 VII of 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 VII REACH Regulation chapter 9.1.1 and 9.1.2 tests for aquatic toxicity to daphnia and aquatic plants 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 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 represent a non-steady state situation from which a defined effective concentration cannot be derived.

Applicant's summary and conclusion

Conclusions:
Tests in aqueous 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 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 represent a non-steady state situation from which a defined effective concentration cannot be derived.