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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:
09 January 2006 to 13 March 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: European Commission, Document ECB/TM/February 1996: ”Particle Size Distribution, Fibre Length and Diameter Distribution" Guidance Document
Deviations:
no
Qualifier:
according to guideline
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 "Particle Size Distribution, Fibre Length and Diameter Distribution" Draft Guidance Document, EUR 20268 EN (2002), Part 5.2 “Laser scattering / diffraction”
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of distribution:
mass based distribution
Specific details on test material used for the study:
Identity: FAT 40824/A
Batch: Red ROE 805 BOP 04/05
Appearance: dark red powder
Purity: Organic part (Na-salt): approx. 82 %; Main component 1: approx. 36.2 %; Main component 2: approx. 27.5 %; Oligomers: 10%
Expiration date: 01 October 2010
Storage: At room temperature at about 20 °C in a desiccator (hygroscopic)
Percentile:
D50
Mean:
< 5 µm
Remarks on result:
other: No source field for Standard deviation.
No.:
#1
Size:
< 0.5 µm
Distribution:
2.58 %
No.:
#2
Size:
< 1 µm
Distribution:
7.3 %
No.:
#3
Size:
< 2 µm
Distribution:
16.22 %
No.:
#4
Size:
< 3 µm
Distribution:
26.83 %
No.:
#5
Size:
< 4 µm
Distribution:
38.73 %
No.:
#6
Size:
< 5 µm
Distribution:
50.44 %
No.:
#7
Size:
< 6 µm
Distribution:
60.99 %
No.:
#8
Size:
< 7 µm
Distribution:
69.82 %
No.:
#9
Size:
< 8 µm
Distribution:
77.06 %
No.:
#10
Size:
< 9 µm
Distribution:
82.76 %

FAT 40824/A is a dark red, fine powder. Under the microscope (with a magnification of 400), dark red globular crystalline structures of different sizes were observed. A solubility test showed, that the test item is both: sparingly soluble and well dispersible in 2-propanol. The particle size distribution of FAT 40824/A was performed with two samples of the stock dispersion each measured in duplicate. The results obtained during the measurements showed no relevant difference. Therefore the study is considered to be valid and no further testing is necessary.


The particle size distribution was found to range from approximately <0.3 µm to <20.0 µm.


 


Table:Particle size distribution of FAT40824/A



















































 


 


 


[%)



1stRun Particle Size [µm]



2nd Run Particle Size [µm]



3rd Run Particle Size [µm]



4th Run Particle Size [µm]



Mean Particle Size [µm]



Stand. Dev.


 


[±)



5



<0.69



<0.69



<0.83



<0.83



<0.8



0.081



10



<1.15



<1.15



<1.57



<1.56



<1.4



0.240



50



<4.43



<4.44



<5.56



<5.52



<5.0*



0.638



90



<9.65



<9.74



<11.95



<11.82



<10.8



1.266



*)The MMD of the test item indicates that 50% (by mass) of the particles are smaller than 5.0 µm.


Table : Particle size distribution of FAT 40824/A in[%] at the relevant particlesize




















































































































































































































































































11m



1st Run


[%]



2nd Run


[%]



3rd Run


[%]



4th Run


[%]



Mean


[%]



Stand. Dev.



<0.3



*****



*****



*****



*****



 



 



<0.5



2.86



2.85



2.30



2.31



2.58



0.32



<1.0



8.41



8.38



6.19



6.23



7.30



1.26



<2.0



19.30



19.25



13.12



13.20



16.22



3.53



<3.0



31.61



31.54



22.01



22.15



26.83



5.48



<4.0



44.62



44.49



32.79



33.01



38.73



6.73



<5.0



56.82



56.63



44.01



44.31



50.44



7.26



<6.0



67.35



67.10



54.57



54.93



60.99



7.20



<7.0



75.81



75.51



63.78



64.19



69.82



6.74



<8.0



82.47



82.15



71.59



72.01



77.06



6.07



<9.0



87.51



87.19



77.95



78.37



82.76



5.31



<10.0



91.23



90.93



83.01



83.41



87.15



4.55



<20.0



100.00



100.00



99.62



99.73



99.84



0.19



<30.0



100.00



100.00



100.00



100.00



100.00



0.00



<40.0



100.00



100.00



100.00



100.00



100.00



0.00



<50.0



100.00



100.00



100.00



100.00



100.00



0.00



<60.0



100.00



100.00



100.00



100.00



100.00



0.00



<70.0



100.00



100.00



100.00



100.00



100.00



0.00



<80.0



100.00



100.00



100.00



100.00



100.00



0.00



<90.0



100.00



100.00



100.00



100.00



100.00



0.00



<100.0



100.00



100.00



100.00



100.00



100.00



0.00



<125.0



100.00



100.00



100.00



100.00



100.00



0.00



<150.0



100.00



100.00



100.00



100.00



100.00



0.00



<175.0



100.00



100.00



100.00



100.00



100.00



0.00



<200.0



100.00



100.00



100.00



100.00



100.00



0.00



<225.0



100.00



100.00



100.00



100.00



100.00



0.00



<250.0



100.00



100.00



100.00



100.00



100.00



0.00



<275.0



100.00



100.00



100.00



100.00



100.00



0.00



<300.0



*****



*****



*****



*****



 



 



 


 

Conclusions:
Median of mass distribution (diameter) of FAT 40824/A is <5.0 μm.
Executive summary:

In a GLP-compliant study, the determination of the particle size distribution of FAT 40824/A 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. FAT 40824/A is a dark red, fine powder. Under the microscope (with a magnification of 400), dark red globular crystalline structures of different sizes were observed. A solubility test showed, that the test item is both: sparingly soluble and well dispersible in 2-propanol. The particle size distribution of FAT 40824/A was performed with two samples of the stock dispersion each measured in duplicate. The results obtained during the measurements showed no relevant difference. Therefore the study is considered to be valid and no further testing is necessary. In conclusion, using the laser diffraction method to study the particle size of FAT 40824/A ranging between 0.3 µm and 300 µm, the mass median diameter (MMD) was determined to be <5.0 µm. The particle size distribution was found to range from approximately <0.3 µm to <20.0 µm.

Description of key information

The median of mass distribution (diameter) of test substance was <5.0 μm.

Additional information

In a GLPcompliant study, the determination of the particle size distribution of FAT 40824/A 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. FAT 40824/A is a dark red, fine powder. Under the microscope (with a magnification of 400), dark red globular crystalline structures of different sizes were observed. A solubility test showed, that the test item is both: sparingly soluble and well dispersible in 2-propanol. The particle size distribution of FAT 40824/A was performed with two samples of the stock dispersion each measured in duplicate. The results obtained during the measurements showed no relevant difference. Therefore the study is considered to be valid and no further testing is necessary. In conclusion, using the laser diffraction method to study the particle size of FAT 40824/A ranging between 0.3 µm and 300 µm, the mass median diameter (MMD) was determined to be <5.0 µm. The particle size distribution was found to range from approximately <0.3 µm to <20.0 µm.