Registration Dossier

Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From September 28, 2010 to September 29, 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted in compliance with international guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: EUROPEAN COMMISSION, Directorate General XII-JRC, Science Research and Development-Joint Research Centre. “Particle Size Distribution, Fibre Length and Diameter Distribution” Guidance Document, ECB/TM/February 1996.
Deviations:
no
Qualifier:
according to
Guideline:
other: 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 “Particle Size Distribution, Fibre Length and Diameter Distribution” Draft Guidance Document, EUR 20268 EN (2002), Part 5.2 “Laser scattering / diffraction”.
Deviations:
no
Principles of method if other than guideline:
The above-mentioned guideline contains several different methods for the determination of the particle size distribution. These methods include sieving, microscopic examination, sedimentation (gravitational settling examination), cascade impaction and laser scattering / diffraction method. In the present study the laser scattering / diffraction was applied.
GLP compliance:
yes (incl. certificate)
Type of distribution:
other: laser scattering / diffraction

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Results and discussion

Particle sizeopen allclose all
Percentile:
D50
Mean:
8.5 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
other: 99%
Mean:
ca. 0.5 - ca. 60 µm
Remarks on result:
other: 0.8% of the particles have a size below 0.5 μm
Percentile:
other: 90%
Mean:
< 24.7 µm
St. dev.:
1.039
Percentile:
other: 10%
Mean:
< 2.3 µm
St. dev.:
0.092
Percentile:
other: 5%
Mean:
< 1.4
St. dev.:
0.045

Any other information on results incl. tables

The tests item is a pink powder. Under the microscope (with a magnification of 100) small-sized and rod-shaped particles with some lumps were observed.

Applicant's summary and conclusion

Executive summary:

The determination of the particle size distribution of the test item was performed according to the European Commission, Document ECB/TM/February 1996: ”Particle Size Distribution, Fibre Length and Diameter Distribution” Guidance Document and the 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” using the laser diffraction method.The test item particle size has been measured on a range between 0.3 μm and 300 μm. The mass median diameter (MMD) was determined to be 8.5 μm. About 99% of the particles were found to range from approximately 0.5 μm to 60.0 μm. Lower range: 0.8% of the particles have a size below 0.5 μm.