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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:
17 January 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
adoptation 2009
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Ministry of Health, Italy
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
Octadecyl docosanoate
EC Number:
246-115-1
EC Name:
Octadecyl docosanoate
Cas Number:
24271-12-3
Molecular formula:
C40H80O2
IUPAC Name:
octadecyl docosanoate

Results and discussion

Remarks on result:
other: Manual sieve analysis indicated that 64% w/w of the sample had a particle size of <1.4 mm, thus the results below represent size distribution after separation of ca. 36% of oversized fraction
Particle sizeopen allclose all
Key result
Percentile:
D90
Mean:
927.181 µm
St. dev.:
132.033
Remarks on result:
other: Mean value is calculated by software of the apparatus Mastersizer 2000 from the data captured in each run and is not a simple arithmetic mean
Key result
Percentile:
D50
Mean:
339.854 µm
St. dev.:
73.843
Remarks on result:
other: Mean value is calculated by software of the apparatus Mastersizer 2000 from the data captured in each run and is not a simple arithmetic mean
Key result
Percentile:
D10
Mean:
71.895 µm
St. dev.:
22.536
Remarks on result:
other: Mean value is calculated by software of the apparatus Mastersizer 2000 from the data captured in each run and is not a simple arithmetic mean

Any other information on results incl. tables

The particle size distribution of the test item was determined in 9 measurements. The instrument generated a mean value and size distributions automatically.

Manual sieve analysis indicated that 64% w/w of the sample had a particle size of <1.4 mm.

Table. Particle size distribution <1.4 mm

 Measurement  L10 D(v, 0.1) [µm]  L50 D(v, 0.5) [µm]  L90 D(v, 0.9) [mm]
 1  98.191  423.476  1059.848
 2  75.344  342.569  921.706
 3  62.576  299.319  837.519
 4  93.914  399.090  1019.719
 5  123.231  488.587  1138.972
 6  74.597  337.527  907.747
 7  45.180  236.528  702.486
 8  59.394  280.480  772.389
 9  64.323  308.805  858.311
       
 Mean Value  71.895  339.854  927.181
 Standard Deviation of the population  22.536  73.843  132.033

The volume mean diameter of the test item labelled as Octadecyl docosanoate (<1.4 mm) was found to be 430.38 µm.

The 90%, 50% and 10% mean cumulative size distributions were found to be 927.18 µm, 339.85 µm and 71.89 µm, respectively.

Applicant's summary and conclusion