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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:
June 25, 2007 - June 26, 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study conform with ECB/TM/February 1996, part 5.2

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Directorate General JRC, Joint Research Centre. “Particle Size Distribution, Fibre Length and Diameter Distribution” Draft Guidance Document, EUR 20268 EN (2002), Part 5.2 “Laser scattering / diffraction” using the laser diffraction method.
GLP compliance:
yes (incl. QA statement)
Type of distribution:
other: The laser diffraction method.

Test material

Constituent 1
Details on test material:
Identity: AES
Batch: LSF7
Purity: 80.3%
Appearance: Solid
Expiration date: February 15, 2008
Storage: In the refrigerator at about 4 °C

Results and discussion

Particle sizeopen allclose all
Percentile:
D50
Mean:
13.5 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
other: mass median diameter (MMD)
Mean:
0.3 - 70 µm

Any other information on results incl. tables

                     Particle Size Distribution of AES

[%]

1st Run Particle Size

[µm]

2st Run Particle Size

[µm]

3st Run Particle Size

[µm]

4st Run Particle Size

[µm]

Mean Particle Size

[µm]

Stand.

Dev.

[±]

5

1.45

1.44

1.37

1.29

1.4

0.074

10

3.29

3.34

2.95

2.66

3.1

0.318

50

13.83

14.04

13.44

12.67

13.5

0.604

90

30.42

31.51

31.89

29.65

30.9

1.023

 The MMD of the test item indicates that 50% (by mass) of the particles are smaller than 13.5 µm

Applicant's summary and conclusion

Conclusions:
In conclusion, using the laser diffraction method to study the particle size of AES ranging between 0.3 μm and 300 μm, the mass median diameter (MMD) was determined to be 13.5 μm. The particle size distribution was found to range from approximately 0.30 μm to 70 μm.
Executive summary:

The results obtained during the measurements showed no relevant difference. Therefore the study is considered to be valid and no further testing is necessary.

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