Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Justification for type of information:
Waiver is proposed for this test based on Column 2, Specific Rules for Adaption from Column 1 for section 8.5, which requires that an oral acute study and an acute study by one other route be conducted. The choice of the second route based on the nature of the substance and the likely route of human exposure. An acute oral and an acute dermal study have been conducted so the acute inhalation is not required.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion