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:
JUSTIFICATION FOR DATA WAIVING
In accordance with column 2 of REACH Annex VIII, information requirement 8.5.2 (acute toxicity by inhalation) does not need to be conducted since information is provided outlining the acute toxicity of the substance by the oral and dermal routes. Testing via the inhalation route is appropriate if exposure of humans via inhalation is 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.
For BPA-DA, exposure via the inhalation route is unlikely due to the low vapour pressure (calculated to be 5E-18 Pa at 25 °C). Furthermore, the possibility of exposure to aerosols, particles or droplets of an inhalable size is unlikely. It is therefore considered justified to omit this study.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion