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Particle size distribution (Granulometry)

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Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2018-03-22 to 2018-05-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7520 (Particle Size, Fiber Length, and Diameter Distribution)
Deviations:
no
Qualifier:
according to
Guideline:
other: CIPAC MT 187 (2009): Particle Size Analysis by Laser Diffraction
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution
Specific details on test material used for the study:
Substance H4 HD granules about 0.8 – 4 mm
Percentile:
D10
Mean:
476.7 µm
St. dev.:
0
Remarks on result:
other:
Remarks:
result of one test series
Key result
Percentile:
D50
Mean:
773.9 µm
St. dev.:
0
Remarks on result:
other:
Remarks:
result of one test series
Percentile:
D90
Mean:
1 235.5 µm
St. dev.:
0
Remarks on result:
other:
Remarks:
result of one test series

The coarse fraction (>1000 µm) was 93.3 wt.-% and the fine fraction (<1000 µm) 6.7 wt.-%. One test series of 3 measurements was performed with the fine fraction of the test item.

A study was performed in accordance with OECD TG 110, EPA OPPTS 830.7520, CIPAC MT 187 and ISO 13320 in order to determine the particle size distribution of the test item using laser diffraction measurement. One test series of three measurements was performed. The particle size distibution of the test item was determined to be D50= 773.9 µm.

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2018-03-22 to 2018-05-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
Deviations:
no
Qualifier:
according to
Guideline:
other: CIPAC MT 59 (2009): Sieve Analysis
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7520 (Particle Size, Fiber Length, and Diameter Distribution)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
sieving
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution
Specific details on test material used for the study:
Substance H4 HD granules about 0.1 – 2 mm
Percentile:
D10
Mean:
379 µm
St. dev.:
0
Remarks on result:
other:
Remarks:
one measurement performed
Key result
Percentile:
D50
Mean:
1 238 µm
St. dev.:
0
Remarks on result:
other:
Remarks:
one measurement performed
Percentile:
D90
Mean:
1 851 µm
St. dev.:
0
Remarks on result:
other:
Remarks:
one measurement performed

Table 1: Results of sieving analysis

Sieve size in µm

Weight in g

Mass %

Total %

> 2000

0.1

0.3

100.00

< 2000

22.5

65.2

99.7

< 1000

7.0

20.3

34.5

< 500

3.0

8.7

14.2

< 250

1.2

3.5

5.5

< 150

0.2

0.6

2.0

< 63

0.5

1.4

1.4

From these results the particle size distribution for the diameters 10, 50 and 90 Vol.-% were calculated via linear regression.

A study was performed in accordance with OECD TG 110, EPA OPPTS 830.7520 and CIPAC MT 59 in order to determine the particle size distribution of the test item using the sieving analysis. Six sieves with different sizes (2000, 1000, 500, 250, 150 and 63 µm) were used. The whole amount of the test item was filled into the sieve with the largest size and sieved until the amount of the test item in the sieve remained constant. Then the top sieve was removed and the sieving was resumed in the sieve with the next lower size. Each residue in the six single sieves were weighted. From the measured diffraction pattern the particle size distribution for 10, 50 and 90 vol.-% of particles were calculated via linar regression. The median particle size (D50) of the test item was determined to be 1238 µm.

Description of key information

For the test item with granule sizes between 0.8 and 4 mm a median particle size of D50 = 773.9 µm was determined (laser diffraction measurement).

For the test item with granule sizes between 0.1 and 2 mm a median particle size of D50 = 1238 µm was determined (sieving method).

Additional information

As the test item will be produced and marketed with different granule sizes (0.1 to 2 mm and 0.8 to 4 mm) for technical reasons two different studies was performed in order to determine the particle size distribution.

Test item 1 (granule sizes 0.8 to 4 mm) (reference 4.5-1)

A study was performed in accordance with OECD TG 110, EPA OPPTS 830.7520, CIPAC MT 187 and ISO 13320 in order to determine the particle size distribution of the test item using laser diffraction measurement. One test series of three measurements was performed. The particle size distibution of the test item was determined to be D50= 773.9 µm.

Test item 2 (granule sizes 0.1 to 2 mm) (reference 4.5-2)

A study was performed in accordance with OECD TG 110, EPA OPPTS 830.7520 and CIPAC MT 59 in order to determine the particle size distribution of the test item using the sieving analysis.

Six sieves with different sizes (2000, 1000, 500, 250, 150 and 63 µm) were used. The whole amount of the test item was filled into the sieve with the largest size and sieved until the amount of the test item in the sieve remained constant. Then the top sieve was removed and the sieving was resumed in the sieve with the next lower size. Each residue in the six single sieves were weighted. From the measured diffraction pattern the particle size distribution for 10, 50 and 90 vol.-% of particles were calculated via linar regression. The median particle size (D50) of the test item was determined to be 1238 µm.