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Physical & Chemical properties

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:
19 April 2016 to 21 April 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
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions) - Method B: Fibre Length and Diameter Distributions
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of particle tested:
agglomerate
Type of distribution:
volumetric distribution
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source: Provided by sposor
- Lot/batch No.of test material: 150701
- Expiration date of the lot/batch: 14 July 2017

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: - Storage conditions: Controlled room temperature (15-25 ºC, below 70 RH%), protected from humidity, under inert gas.
Mass median aerodynamic diameter:
>= 554.13 - <= 565.76 µm
Geometric standard deviation:
>= 1.774 - <= 1.829
Key result
Percentile:
D10
Mean:
207.626 µm
St. dev.:
8.052
Remarks on result:
other: Standard deviation of the population reported.
Key result
Percentile:
D50
Mean:
508.937 µm
St. dev.:
3.952
Remarks on result:
other: Standard deviation of the population reported.
Key result
Percentile:
D90
Mean:
883.739 µm
St. dev.:
4.953
Remarks on result:
other: Standard deviation of the population reported.
No.:
#1
Size:
< 10 µm
Distribution:
0.31 %

Table 1. Full particle size test results

 

RUN 1

RUN 2

RUN 3

RUN 4

RUN 5

**Average

Volume weighted Mean

530.577

520.860

531.571

531.170

531.494

529.134

Median (d.50)

510.431

501.070

510.875

510.729

511.582

508.937

Mode (μm)

558.958

551.977

558.803

556.656

558.373

556.945

*MMAD

564.48

554.13

564.97

564.81

565.76

562.83

10 % of material is <

 

206.779

192.853

 

208.828

 

214.744

214.762

207.626

50 % of material is <

510.431

501.070

510.875

510.729

511.582

508.937

90 % of material is <

887.636

874.262

887.872

883.959

884.510

883.739

All results are in μm

* Mass Median Aerodynamic Diameter

** Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.

0.31 % by volume of sample was seen to be < 10.00 μm.

Standard Deviation Results

Run No.

1

2

3

4

5

STDVP

% STDVP

D10

206.779

192.853

208.828

214.744

214.762

8.025

3.9

D50

510.431

501.070

510.875

510.729

511.582

3.952

0.8

D90

887.636

874.262

887.872

883.959

884.510

4.953

0.6

D15.78

283.475

273.962

284.755

287.852

287.869

5.110

1.8

GSD

1.801

1.829

1.794

1.774

1.777

0.020

1.1

MMAD

564.48

554.13

564.97

564.81

565.76

4.37

0.8

GSD = Geometric standard deviation of the lognormal particle size distribution

STDVP = standard deviation of the population

% STDVP = percentage standard deviation of the population

Coefficient of variation for d50 is less than 3 %; d10 and d90 are less than 5 %. Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.

Conclusions:
Under the conditions of this study the average size of the particles was determined to be 508.937 microns.
Executive summary:

A determination of the particle size distribution of the test material was carried out in accordance to the standardised guidelines ISO 13320:2009, CIPAC MT 187 with consideration of OECD 110 under GLP conditions.

The particle size of the test material was determined through laser diffraction using a particle size analyser. The sample proved to be insoluble, and well dispersed in methanol, therefore methanol was used for the suspension fluid. 5 runs were perfomed to ensure repeatability of results.

Under the conditions of this study the average size of the particles was determined to be 508.937 microns.

Description of key information

Under the conditions of this study the average size of the particles was determined to be 508.937 microns.

Additional information

A determination of the particle size distribution of the test material was carried out in accordance to the standardised guidelines ISO 13320:2009, CIPAC MT 187 with consideration of OECD 110 under GLP conditions. The study was assigned a reliability score of 1 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).

The particle size of the test material was determined through laser diffraction using a particle size analyser. The sample proved to be insoluble, and well dispersed in methanol, therefore methanol was used for the suspension fluid. 5 runs were perfomed to ensure repeatability of results.

Under the conditions of this study the average size of the particles was determined to be 508.937 microns.