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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:
10th April to 12th June 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: - Study generated according to generally valid and/or internationally accepted testing guidelines - Performed according to GLP - Test parameters based on specific testing guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
yes
Remarks:
Yes First Amendment to Study Plan: Concerning: Schedule Alteration: New experimental starting and completion date Reason for the alteration: Delay in study
Principles of method if other than guideline:
EUROPEAN COMMISSION, Directorate General Xll-JRC, Science Research and Development-Joint Research Centre. ‘Particle Size Distribution, Fibre Length and Diameter Distribution” Guidance Document, ECB/TM/February 1996.

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 “Particle Size Distribution, Fibre Length and Diameter Distribution” Draft Guidance Document, EUR 20268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
Type of method:
Laser scattering/diffraction
Type of distribution:
counted distribution
Percentile:
D50
Mean:
< 116.8 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
other: D5
Mean:
< 12.7 µm
St. dev.:
3.021
Percentile:
D10
Mean:
< 24.9 µm
St. dev.:
3.14
Percentile:
D50
Mean:
< 116.8 µm
St. dev.:
6.364
Percentile:
D90
Mean:
< 218.2 µm
St. dev.:
3.411

FP-100 is a white and slightly grainy powder. Under the microscope (with a magnification of 400) colourless, rectangular formed crystalline structures were observed.

 

A solubility test showed, that the test item is both: sparingly soluble and well dispersible in a water/Sympatens mixture. The particle size distribution of FP-100 was performed with two stock dispersions each measured in duplicate.

 

The individual measurements and the results obtained using the laser diffraction method of FP-100 are summarised in Table 1 and Table 2 of attached report. The tables represent rounded results obtained by using the exact measurement data. An example of the particle size distribution curve is shown in Figure 1 of attached report.

 

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 FP-100 ranging between 0.3 µm and 300 µm, the mass median diameter (MMD) was determined to be 116.8 µm.

 

The particle size distribution was found to range from approximately 0.3 µm to 300 µm, with 4.37% of material having a diameter < 10 µm.

 

Conclusions:
In conclusion, using the laser diffraction method to study the particle size of FP-100 ranging between 0.3 µm and 300 µm, the mass median diameter (MMD) was determined to be
116.8 µm.

The particle size distribution was found to range from approximately 0.3 µm to 300 µm, with 4.37% of material having a diameter < 10 µm.
Executive summary:

Not provided

Description of key information

In conclusion, using the laser diffraction method to study the particle size of FP-100 ranging between 0.3 µm and 300 µm, the mass median diameter (MMD) was determined to be
116.8 µm.
The particle size distribution was found to range from approximately 0.3 µm to 300 µm, with 4.37% of material having a diameter < 10 µm.

The FP-110T in pellet form has particle size up to 30mm

Additional information