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Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 9, 2014 - October 10, 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant study in accordance with ISO 13320 and CIPAC MT 187.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: ISO 13320:2009
Deviations:
no
Qualifier:
according to
Guideline:
other: CIPAC MT 187
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): L 165
- Appearance: White, powdery solid
- Relative density: 4.48

Results and discussion

Mass median aerodynamic diameter:
17.059 - 17.476 µm
Geometric standard deviation:
2.634 - 2.673
Particle sizeopen allclose all
Percentile:
D50
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
D10
Mean:
1.827 µm
St. dev.:
0.002
Remarks on result:
other: Population standard deviation [µm]
Percentile:
D50
Mean:
8.18 µm
St. dev.:
0.071
Remarks on result:
other: Population standard deviation [µm]
Percentile:
D90
Mean:
16.742 µm
St. dev.:
0.089
Remarks on result:
other: Population standard deviation [µm]
Particle size distribution at different passages
Size:
< 10 µm
Distribution:
62.01 %

Any other information on results incl. tables

MMAD mean: 17.315 µm (population standard deviation: 0.15 µm)

Mode: 10.249 µm

 

Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.

Applicant's summary and conclusion

Conclusions:
In a GLP-compliant study in accordance with ISO 13320 and CIPAC MT 187 using the laser diffraction analysis-'wet' small volume dispersion method, the particle size distribution of a sample of the substance was determined (volumetric distribution): 10% is < 1.8 µm; 62% is < 10 µm; 50% is < 8.2 µm and 90% is < 16.7 µm. The MMAD is 17.3 µm.