Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
a sub-chronic toxicity study (90 days) does not need to be conducted because a reliable chronic toxicity study is available, conducted with an appropriate species and route of administration
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING :
The test substance is a solid with a low vapour pressure. A single continuous 4 h period to an atmosphere of aerosolized test substance dust at the highest attainable exposure concentration in air gives no evidence for local and systemic toxicity. Thus the oral route seems to be the appropiate route of adiministration to characterize the inherent hazard of the substance after repeated exposure.

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion