Registration Dossier

Environmental fate & pathways

Biodegradation in water and sediment: simulation tests

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Administrative data

Endpoint:
biodegradation in water: sewage treatment simulation testing
Data waiving:
study technically not feasible
Justification for data waiving:
the study does not need to be conducted because the substance is highly insoluble in water
other:
Justification for type of information:
Tests in aqueous or moist media with ethyl 2-cyanoacrylate 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).

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
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. 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.
Waiving justification based on Annex IX, REACH Regulation
According Annex IX, REACH Regulation simulation tests for biodegradability in surface water, soil or sediment are not necessary if the registered substance is amongst other properties ‘readily biodegradable’. A direct determination of the biodegradation of ethyl 2-cyanoacrylate (EC 230-391-5) in screening tests is not possible due to the instant polymerisation reaction. The calculation tool BIOWIN 4.10 in EPI Suite 4.11 predicts fast biodegradation of the monomer and ready biodegradability can be expected. This is supported by the biodegradation study with ethyl-2-cyanoacetate (see Environmental Fate & Pathways, Biodegradation in Water: Screening Tests). Therefore, according Annex IX section 9.2 simulation tests for biodegradability in surface water, soil or sediment are not necessary.
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

% Degradation
Remarks on result:
other: study technically not feasible: Test substance polmerises on contact with water within seconds
Half-life of parent compound / 50% disappearance time (DT50)
Remarks on result:
other: study technically not feasible: Test substance polmerises on contact with water within seconds

Any other information on results incl. tables

Study technically not feasible → Tests in aqueous or moist media with ethyl 2-cyanoacrylate 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).

Applicant's summary and conclusion

Conclusions:
Tests in aqueous or moist media with ethyl 2-cyanoacrylate 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 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).