Registration Dossier

Administrative data

Endpoint:
repeated dose toxicity: oral
Data waiving:
study technically not feasible
Justification for data waiving:
other:

Data source

Materials and methods

Results and discussion

Effect levels

Basis for effect level:
other: Study technically not feasible: test substance polymerizes immediately.
Remarks on result:
not measured/tested
Remarks:
Effect level not specified (migrated information)

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Study technically not feasible: test substance polymerizes immediately.

Applicant's summary and conclusion

Conclusions:
Study technically not feasible: test substance polymerizes immediately.
Executive summary:

Tests in aqueous media with 2-phenylethyl 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 -phenylethyl cyanoacrylate polymerizes within seconds (inherent property of cyanoacrylate based instant glues). Thus, very low determined monomer concentrations in water represent a non steady state situation from which a defined effective concentration can not be derived. 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.