Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
study technically not feasible
Justification for data waiving:
other:
Justification for type of information:
Test not performed because 2-methoxyethyl 2-cyanoacrylate is highly reactive to water resulting in fast polymerization process (in seconds) thus the nature of the substance does not allow to be tested for the endpoint Toxicity to Reproduction.
The physico-chemical characteristics of 2-methoxyethyl 2-cyanoacrylate:
- dramatically limit or exclude testing of certain assays since its reactivity with water results immediately into a polymer;
- may also prevent administration of precise and consistent doses of the chemical for both in vitro studies and in vivo studies
As it is described in the Guidance on information requirements and chemical safety assessment Chapter R.5: Adaptation of information requirements chapter (R.5.2.2 Testing is technically not possible (page 28)) the waiver is herewith justified. Conform Annex XI section 2 of REACH it is possible omit any required information under the justification that testing is technically not possible.

Data source

Materials and methods

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Test not performed because 2-methoxyethyl 2-cyanoacrylate is highly reactive to water resulting in fast polymerization process (in seconds) thus the nature of the substance does not allow to be tested in water containing medium.
The physico-chemical characteristics of 2-methoxyethyl 2-cyanoacrylate:
- dramatically limit or exclude testing of certain assays since its reactivity with water results immediately into a polymer;
- may also prevent administration of precise and consistent doses of the chemical for both in vitro studies and in vivo studies.
As it is described in the Guidance on information requirements and chemical safety assessment Chapter R.5: Adaptation of information requirements chapter (R.5.2.2 Testing is technically not possible (page 28)) the waiver is herewith justified.
Conform Annex XI section 2 of REACH it is possible omit any required information under the justification that testing is technically not possible.

Executive summary:

Tests in aqueous media with 2-methoxyethyl 2-cyanoacrylate with the intent to determine effective concentrations or no effect concentrations can not be performed due to technical reasons based on the chemical properties of the monomer. In presence of moisture 2-methoxyethyl cyanoacrylate polymerizes within seconds (inherent property of cyanoacrylate based instant glues). Oral administration would be the most appropriate way. The monomer would polymerize in the oral cavity or when administered by gavage in the stomach. The application in the feed is not possible as the monomer polymerizes immediately on contact with food. This would allow only the polymer to be tested.


Conform Annex XI section 2 of REACH it is possible omit any required information under the justification that testing is technically not possible.