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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:
February - April 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 169 & 170
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
sieving
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Test Substance Name: LZ 514
- Source: Lonza Ltd, Visp/Switzerland
- Lot/batch No.of test material: 5011
- Expiration date of the lot/batch: 2nd December 2017
- Manufacture date: 3rd December 2015

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage conditions: Controlled room temperature (15-25 ºC, below 70 RH%), protected from light and humidity.
- Stability under test conditions: stable
- Safety precautions: Routine safety precautions (lab coat, gloves, safety glasses, face mask) for unknown materials were applied to assure personnel health and safety.
Remarks on result:
not determinable because of methodological limitations
Key result
Percentile:
D10
Mean:
> 4 µm
St. dev.:
0
Key result
Percentile:
D90
Mean:
> 125 µm
St. dev.:
0
No.:
#1
Size:
63 µm
Distribution:
98.1 %
Remarks on result:
other: sum of residues Rx %
No.:
#2
Size:
125 µm
Distribution:
93.4 %
Remarks on result:
other: sum of residues Rx %
No.:
#3
Size:
250 µm
Distribution:
86 %
Remarks on result:
other: sum of residues Rx %
No.:
#4
Size:
500 µm
Distribution:
69.8 %
Remarks on result:
other: sum of residues Rx %
No.:
#5
Size:
1 000 µm
Distribution:
46.4 %
Remarks on result:
other: sum of residues Rx %
No.:
#6
Size:
2 000 µm
Distribution:
29.8 %
Remarks on result:
other: sum of residues Rx %
No.:
#7
Size:
4 000 µm
Distribution:
0.1 %
Remarks on result:
other: sum of residues Rx %
Conclusions:
The particle size distribution of the test item was found to be [125 μm; 4000 μm]. Less than 10% of the test item is larger than 4 mm and more than 90% is larger than 125 μm.
Executive summary:

The study was performed according to CIPAC methods MT 169 & 170, using the sieving method.

The particle size distribution of the test item was found to be [125 μm; 4000 μm]. Less than 10% of the test item is larger than 4 mm and more than 90% is larger than 125 μm.

Description of key information

The study was performed according to CIPAC methods MT 169 & 170, using the sieving method.

The particle size distribution of the test item was found to be [125 μm; 4000 μm]. Less than 10% of the test item is larger than 4 mm and more than 90% is larger than 125 μm.

Additional information

Source: GLP-report