Registration Dossier

Diss Factsheets

Administrative data

acute toxicity: inhalation
Data waiving:
exposure considerations
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:
The TMAO target substance is a low volatile non-inhalable powder. The vapour pressure of 23.5 Pa at 20 °C is reported with a MMAD of 414.329 µm with a D10 of 161.713 µm. This measured data supports the waiver as a low volatile substance, vapour pressure is less than 0.5 kPa, that is not inhalable, particles with aerodynamic diameters greater than 100 μm (ECHA, 2017).

ECHA, 2017. Guidance on Information Requirements and Chemical Safety Assessment. Chapter R.7c: Endpoint specific guidance. Version 3.0 June 2017.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion