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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:
28 April, 2014 to 03 September, 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of distribution:
other: dry dispersion
Percentile:
D10
Mean:
1.1 µm
Remarks on result:
other: Std deviation not specified
Key result
Percentile:
D50
Mean:
10.8 µm
Remarks on result:
other: median particle size
Percentile:
D90
Mean:
93.7 µm
Remarks on result:
other: Std deviation not specified
Conclusions:
Median particle size of FAT 92368/Y TE was found to be 10.8 µm. This value is also used as MMAD.
Executive summary:

Particle size distribution of FAT92368/Y TE was determined according to CIPAC MT 187 using laser diffraction method with dry dispersion. Malvern Mastersizer 2000 was used for determination of particle size distribution. Based on the findings of the study, median particle size was found to be 10.8 µm, whereas L10D and L90D were found to be 1.1 and 93.7 µm, respectively.

Description of key information

Particle size distribution of FAT 92368/Y TE was determined according to CIPAC MT 187 using laser diffraction method with dry dispersion. Malvern Mastersizer 2000 was used for determination of particle size distribution. Based on the findings of the study, median particle size was found to be 10.8 µm, whereas L10D and L90D were found to be 1.1 and 93.7 µm, respectively.

Additional information