Registration Dossier

Physical & Chemical properties

Particle size distribution (Granulometry)

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
other: ISO 13320:2009
Deviations:
no
Qualifier:
according to
Guideline:
other: CIPAC MT 187
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
no
Principles of method if other than guideline:
- Initially observation to determine whether sieving of the material is required
- Malvern Mastersizer 2000 laser Diffraction Analyser
GLP compliance:
yes (incl. certificate)
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Mass median aerodynamic diameter:
74.414 µm
Geometric standard deviation:
1.35
Percentile:
D50
Mean:
78.074 µm
Remarks on result:
other: 10 % of the material is < 28.092 µm, 50 % of the material is < 68.504 µm and 90 % of material the is < 144.720 µm
Mean:
78.074 µm
Remarks on result:
other: Volume weighted mean (mean value of 5 runs)
Mean:
68.504 µm
Remarks on result:
other: Median (d.50) (mean value of 5 runs)
Mean:
72.524 µm
Remarks on result:
other: Mode (mean value of 5 runs)
Mean:
74.414 µm
Remarks on result:
other: MMAD (Mass Median Aerodynamic Diameter) (mean value of 5 runs)

Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.

Conclusions:
The MMAD (Mass Median Aerodynamic Diameter < 100 ¿m) has a mean value of 74.41 ¿m for Androst-4-ene-3,17-dione.
Executive summary:

As the sample is believed to be toxic, the analysis was carried out using the `wet¿, small volume dispersion system. Several solvents were tried, in order to determine a suitable medium that provided maximum dispersability, but with minimum solubility. Silicone oil was finally selected as the most suitable dispersant. The particle size distribution was analysed over the range 0.02 µm to 2000 µm by the laser diffraction test. The median diameter (volume weighted mean) was 78.074µm. 3.89 % by volume of sample was seen to be < 10.00 µm. The MMAD (Mass Median Aerodynamic Diameter < 100 µm) has a mean value of 74.41 µm for Androst-4-ene-3,17-dione.

Description of key information

The MMAD (Mass Median Aerodynamic Diameter < 100 µm) has a mean value of 74.41 µm for Androst-4-ene-3,17-dione.

Additional information

Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.