Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
a short-term toxicity study does not need to be conducted because a reliable sub-chronic (90 days) or chronic toxicity study is available, conducted with an appropriate species, dosage, solvent and route of administration
Justification for type of information:
The inhalational route of exposure is not considered most relevant route for further examining repeated dose toxicity as systemic effects are considered better to be examined in an oral study. The use of the OEL from ACGIH as an inhalational DNEL for local effects from the substance also makes further inhalation testing less relevant.

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion