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:
2009-03-10 - 2009-08-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: 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: 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 “Particle Size Distribution, Fibre Length and Diameter Distribution” Draft Guidance Document, EUR 20268 EN (2002), Part 5.2 “Laser scattering / diffraction”.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 laser scattering / diffraction was used to determine the particle size distribution, the test item was measured with the test system as described below.
GLP compliance:
yes (incl. certificate)
Type of method:
Laser scattering/diffraction
Type of distribution:
counted distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): LCA08042
- Substance type: white and beige solid
- Physical state: solid
- Analytical purity: 99.4%
- Lot/batch No.: 0826000002
- Expiration date of the lot/batch: September 16, 2001
- Storage condition of test material: At room temperature (about 20°C)






Results and discussion

Particle sizeopen allclose all
Percentile:
D50
Mean:
162.8 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
other: D05
Mean:
15.3 µm
St. dev.:
1.404
Remarks on result:
other: Mean and SD from four determinations.
Percentile:
D10
Mean:
26 µm
St. dev.:
1.924
Remarks on result:
other: Mean and SD from four determinations.
Percentile:
D50
Mean:
162.8 µm
St. dev.:
2.625
Remarks on result:
other: Mean and SD from four determinations.
Percentile:
D90
Mean:
272.4 µm
St. dev.:
0.541
Remarks on result:
other: Mean and SD from four determinations.
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
> 0 - < 0.3 µm
Distribution:
0 %
No.:
#2
Size:
> 0.3 - < 5 µm
Distribution:
1.95 %
No.:
#3
Size:
> 0.3 - < 10 µm
Distribution:
3.25 %
No.:
#4
Size:
> 0.3 - < 50 µm
Distribution:
20.1 %
No.:
#5
Size:
> 0.3 - < 100 µm
Distribution:
31.38 %
No.:
#6
Size:
> 0.3 - < 200 µm
Distribution:
63.45 %
No.:
#7
Size:
> 0.3 - < 250 µm
Distribution:
81.9 %
No.:
#8
Size:
> 0.3 - < 300 µm
Distribution:
100 %

Applicant's summary and conclusion

Conclusions:
Using the laser diffraction method to study the particle size of LCA08042 ranging between 0.3 μm and 300 μm, the mass median diameter (MMD) was determined to be 162.8 μm. The particle size distribution was found to range from approximately 0.3 μm to 300 μm.
Executive summary:

The determination of the particle size distribution of LCA08042 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.

With this method, the mass median diameter (MMD) was determined to be 162.8 μm. The particle size distribution was found to range from approximately 0.3 μm to 300 μm.