Registration Dossier

Physical & Chemical properties

Particle size distribution (Granulometry)

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

The solid substance consists of inhalable particles.

Additional information

The particle size distribution of the test item FAT 40850/A TE was tested in a valid GLP study according to EUROPEAN COMMISSION, Directorate General JRC, Joint Research Centre. “Particle Size Distribution, Fibre Length and Diameter Distribution” Draft Guidance Document, EUR 20268 EN (2002), Part 5.2 “Laser scattering / diffraction”.

A solubility test showed that the test item is both: sparingly soluble and well dispersible in 2-propanol. The particle size distribution of FAT 40850/A TE was performed with two samples of the stock dispersion each measured in duplicate. The results obtained during the measurements showed no relevant difference. Therefore the study is considered to be valid and no further testing is necessary. In conclusion, using the laser diffraction method to study the particle size of FAT 40850/A TE ranging between 0.3 µm and 300 µm, the mass median diameter (MMD) was determined to be 6.2 µm.

The particle size distribution was found to range from approximately 0.3 µm to 30.0 µm.