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Diss Factsheets

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:
February 16, 2015 - February 20, 2015
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:
2015
Report date:
2015

Materials and methods

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

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): L 131
- Appearance: Faint light-green powder
- Relative density: 3.70

Results and discussion

Mass median aerodynamic diameter:
23.652 - 23.85 µm
Geometric standard deviation:
3.655 - 3.663
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:
2.053 µm
St. dev.:
0.003
Remarks on result:
other: Population standard deviation [µm]
Percentile:
D50
Mean:
12.361 µm
St. dev.:
0.039
Remarks on result:
other: Population standard deviation [µm]
Percentile:
D90
Mean:
25.979 µm
St. dev.:
0.227
Remarks on result:
other: Population standard deviation [µm]
Particle size distribution at different passages
Size:
< 10 µm
Distribution:
40.08 %

Any other information on results incl. tables

MMAD mean: 23.777 µm (population standard deviation: 0.07 µm)

Mode mean: 16.530 µm

 

Coefficient of variation for d50 is less than 3% (0.3%); d10 and d90 are less than 5% (0.2 and 0.9%). 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 < 2.1 µm; 40.1% is < 10 µm; 50% is < 12.4 µm and 90% is < 26 µm. The MMAD is 23.8 µm.