Registration Dossier

Administrative data

developmental toxicity
Adequacy of study:
weight of evidence
Rationale for reliability incl. deficiencies:
other: Study not experimental performed.
Data waiving:
study technically not feasible
Justification for data waiving:

Data source

Materials and methods

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Basis for effect level:
other: effect type not specified

Results (fetuses)

Fetal abnormalities

not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

Study technically not feasible: test substance would polymerized immediately.

Applicant's summary and conclusion

Study technically not feasible: test substance would polymerized immediately.
Executive summary:

Tests in aqueous media with ethyl 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 ethyl 2-cyanoacrylate polmerises within seconds (inherent property of ethyl 2-cyanoacrylate based instant glues). Thus, very low determined monomer concentrations in water represent a non ateady state situation from which a defined effective concentration can not be derived. Oral administration would be the most appropriate way. The monomer would polymerized 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.