Registration Dossier

Administrative data

Endpoint:
repeated dose toxicity: inhalation
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:
other:

Data source

Materials and methods

Results and discussion

Effect levels

Basis for effect level:
other: Study technically not feasible: test substance would polymerized 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 would polymerized immediately.

Applicant's summary and conclusion

Conclusions:
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. Dry room conditions are unreasonable for the animals. This would result in the animals with severe health problems that would affect the test results.