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Physical & Chemical properties

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:
7 - 27 February 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at dry and dark place between 5 - 30 degCelsius
Percentile:
D10
Mean:
14.2 µm
St. dev.:
0.38
Key result
Percentile:
D50
Mean:
48.5 µm
St. dev.:
0.64
Percentile:
D90
Mean:
116.1 µm
St. dev.:
1.15
Conclusions:
The test item Reactive Red 45:1 has a volumetric based median particle size D50 of 48.5 µm, which was determined by laser diffraction measurement.
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
10.03.2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Deviations:
no
Principles of method if other than guideline:
The laser diffraction based on the Mie-scattering theory was selected for determination.
A representative sample, dispersed at an adequate concentration in a suitable liquid, is passed through the beam of a monochromatic light source (laser). A multi-element detector measures the light scattered by the particles at various angles and numerical values relating to the scattering pattern are then recorded for subsequent analysis. These numerical scattering values are then transformed, using an appropriate optical model and mathematical procedure (Mie theory), to yield the proportion of total volume to a discrete number of size classes forming a volumetric particle size distribution.
GLP compliance:
no
Other quality assurance:
ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution
Mass median aerodynamic diameter:
23.6 µm
Key result
Percentile:
D90
Mean:
38.6 µm
St. dev.:
1.4
Key result
Percentile:
D10
Mean:
12.2 µm
St. dev.:
0.4

Table No.1: Results of determination of particle size distribution

Determination

Median

(mm)

Diameter on Cumulative 90%

(µm)

Diameter on Cumulative 10%

(µm)

Span

(-)

1

22.4

37.4

11.5

1.2

2

23.6

38.6

12.2

1.1

3

23.7

38.7

12.2

1.1

4

24.9

41.2

12.7

1.1

5

23.4

38.6

12.1

1.1

Average

23.6

38.9

12.1

1.1

Standard deviation

0.9

1.4

0.4

0.0

Extended uncertainty

1.8

2.8

0.8

-

Conclusions:
See Executive Summary
Executive summary:

The particle size distribution of the test substance, Reactive Red 45:1 was determined. The laser diffraction method was used.

The procedures used in the study were in accordance with:

Guidance Document on the Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances, EUR 20268 EN (2002).

Standard ISO 13320: 2009 Particle size analysis – Laser diffraction methods, First edition 2009-10-01.

 

 

 

 

 

Particle size distribution of test substance, Reactive Red 45:1, is characterized by the following table:

 

Determination

Median

(mm)

Diameter on Cumulative 90%

(µm)

Diameter on Cumulative 10%

(µm)

Span

(-)

Final result

23.6

38.6

12.2

1.1

Extended uncertainty

1.8

2.8

0.8

-

 

Description of key information

The test item Reactive Red 45:1 has a volumetric based median particle size D50 of 48.5 µm, which was determined by laser diffraction measurement.

Additional information

The particle size is dependent on the production process. In the supporting study, a median particle size of 23.6 µm was observed.