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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:
Experiment start date - 02 March 1999; Experiment end date - 05 March 1999; Study completion date - 09 June 1999.
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: "Partiele Size Distribution Fibre Length and Diameter Distribution", Guidance Document.
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Specific details on test material used for the study:
The test article had the following physico-chemical properties:
Name: 40574/B
Batch no: WP 23/PP
Expiry date: 08 February 2006
Storage: At room temperature about 20 °C.
Percentile:
D50
Mean:
<= 7.19 µm
Remarks on result:
other: Std deviation not available

Particle size distribution:
<3.22 µm: 10 %
<4.96 µm: 25 %
<7.19 µm: 50 %
<10.12 µm: 75 %

Conclusions:
In conclusion it can be stated that the particles found are in the range between about 0.4 µm and 40 µm 50 % of the particles of FAT the substance are smaller than 7.19 µm (median mass diameter).
Executive summary:

The determination of the particle size distribution of FAT 40574/B 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 40574/B is a red fine powder. Under the microscope with a scale up factor of 400 red, spherical structures became visible. A solubility test showed, that the test item is not soluble in n-hexane as the solvent remained colourless after shaking, ultrasonification and filtration (0.45 µm). For the particle size distribution measurement FAT 40574/B was dispersed twice in n-hexane. Each solution was 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 it can be stated that the particles found are in the range between about 0.4 µmand 40 µm, 50 % of the particles of FAT 40574/B are smaller than 7.19 µm(median mass diameter).

Description of key information

The particles found are in the range between about 0.4 µm and 40 µm 50 % of the particles of FAT 40574/B are smaller than 7.19 µm (median mass diameter).

Additional information

The determination of the particle size distribution of FAT 40574/B 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 40574/B is a red fine powder. Under the microscope with a scale up factor of 400 red, spherical structures became visible. A solubility test showed, that the test item is not soluble in n-hexane as the solvent remained colourless after shaking, ultrasonification and filtration (0.45 µm). For the particle size distribution measurement FAT 40574/B was dispersed twice in n-hexane. Each solution was 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 it can be stated that the particles found are in the range between about 0.4 µm and 40 µm, 50 % of the particles of FAT 40574/B are smaller than 7.19 µm (median mass diameter).