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Physical & Chemical properties

Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experimental starting date - 16 March 2005; Experimental completion date - 18 March 2005; Study completion date - 25 May 2005.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: EC, 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
Version / remarks:
February 1996
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Specific details on test material used for the study:
Identity: FAT 40819/A
Description: Red brown powder
Batch number: Red ROE 420 BOP 01/04
Purity: approx. 77 %
Stability of test item: Stable under storage condition
Expiry date: 02 November 2009
Stability of test item dilution: Stable in PEG 300 for at least 7 days at room temperature
Storage conditions: At room temperature.
Mass median aerodynamic diameter:
< 3.9 µm
Percentile:
D10
Mean:
< 1.1 µm
St. dev.:
0.01
Percentile:
D50
Mean:
< 3.9 µm
St. dev.:
0.053
Percentile:
D90
Mean:
< 9.8 µm
St. dev.:
0.97
No.:
#1
Size:
< 0.64 µm
Distribution:
5 %
No.:
#2
Size:
< 1.1 µm
Distribution:
10 %
No.:
#3
Size:
< 3.9 µm
Distribution:
50 %
No.:
#4
Size:
< 9.8 µm
Distribution:
90 %

Table 1 : Particle size distribution of FAT 40819/A


















































 %1st Run Particle Size [micrometer]2nd Run Particle Size [micrometer]3rd Run Particle Size [micrometer]4th Run Particle Size [micrometer] Mean Particle size (micrometer) 

Stand.


Dev. (+/-) 


 5 <0.64  <0.65 <0.64  <0.64  <0.6 0.005
 10 <1.09  <1.11<1.10<1.09<1.1 0.010
 50 <3.79<3.84 <3.90 <3.90  <3.9*0.053 
 90 <8.60<9.61 <10.94 <10.02 <9.8 0.970 

*) The MMD of the test item indicates that 50 % (by mass) of the particles are smaller than 3.9 µm.

Conclusions:
The mass median diameter (D50) of the test substance is 3.9 µm. The particle size distribution was found to range from approximately 0.3 µm to 40 µm.
Executive summary:

In a GLP compliant study, using the laser scattering/diffraction method, the mass median diameter of the test substance was determined.

The particle size distribution was found to range from approximately 0.3 µm to 40 µm. The mass median diameter (D50) of the test substance is 3.9 µm.

Description of key information

In a GLP-compliant study, using the laser scattering/diffraction method, the mass median diameter of the test substance was determined. The particle size distribution was found to range from approximately 0.3 µm to 40 µm. The mass median diameter (D50) of the test substance is 3.9 µm.

Additional information