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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:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: EC, (Particle Size, Fiber Length, and Diameter Distribution), ECB/TM/February 1996
GLP compliance:
yes
Type of method:
Laser scattering/diffraction
Type of particle tested:
other: Not specified
Type of distribution:
other: Particle size distribution
Mass median aerodynamic diameter:
< 22.6 µm
Key result
Percentile:
D90
Mean:
<= 43.57 µm
Remarks on result:
other: Particle found are in the following range.
Key result
Percentile:
D50
Mean:
< 22.6 µm
Remarks on result:
other: 50 % of the particles of the test item are smaller than 22.6 micrometer (Mass Median Diameter)
No.:
#1
Size:
< 5.24 µm
Distribution:
5 %
Remarks on result:
other: Please see table below for more details.
No.:
#2
Size:
< 9.18 µm
Distribution:
10 %
Remarks on result:
other: Please see table below for more details.
No.:
#3
Size:
< 22.59 µm
Distribution:
50 %
Remarks on result:
other: MMD of the test item. It means, that 50% of the particles are smaller than 22.6 micrometer.
No.:
#4
Size:
< 43.57 µm
Distribution:
90 %
Remarks on result:
other: Please see table below for more details.

 


Table 1 : Particle size distribution of FAT 60253/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 <5.5 <4.41<6.20 <4.81 <5.240.794
 10 <9.55 <8.36<10.02<8.79<9.180.745
 50 <22.85<21.81 <23.45 <22.23 <22.590.718
 90 <42.90<42.46<46.23<42.70 <43.57 1.781 

*) The MMD of the test item indicates that 50 % (by mass) of the particles are smaller than 22.6 Mm.

Conclusions:
In conclusion it can be stated that the particles found are in the range between about 0.5 µm and 70 µm. 50 % of the particles of FAT 60253/A are smaller than 22.6 µm (mass median diameter).
Executive summary:

The determination of the particle size distribution of FAT 60'253/A was performed according to the European Commission, Document ECB/TM/February 1996: "Particle Size Distribution Fibre Length and Diameter Distribution", Guidance Document using the laser diffraction method. FAT 60253/A is a yellow fine powder. Under the microscope with a scale up factor of 250 slightly yellow crystals with spherical structures became visible. In conclusion, it can be stated that the particles found are in the range between about 0.5 um and 70 um. 50 % of the particles of FAT 60253/A are smaller than 22.6 µm (mass median diameter).

Description of key information

In conclusion it can be stated that the particles found are in the range between about 0.5 um and 70 um. 50 % of the particles of FAT 60253/A are smaller than 22.6 µm (mass median diameter).

Additional information

The determination of the particle size distribution of FAT 60253/A was performed according to the European Commission, Document ECB/TM/February 1996: "Particle Size Distribution Fibre Length and Diameter Distribution", Guidance Document using the laser diffraction method. FAT 60253/A is a yellow fine powder. Under the microscope with a scale up factor of 250 slightly yellow crystals with spherical structures became visible. In conclusion it can be stated that the particles found are in the range between about 0.5 µm and 70 um. 50 % of the particles of FAT 60253/A are smaller than 22.6 urn (mass median diameter).