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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:
20 July 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The study was conducted according to a EU guideline study. No deviation affected the quality of the study. The substance is considered to be adequately characterised. Therefore full validation applies.
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
Version / remarks:
1981
Deviations:
no
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7520 (Particle Size, Fiber Length, and Diameter Distribution)
Version / remarks:
1996
Deviations:
no
Principles of method if other than guideline:
The particle size distribution was determined using laser diffraction. As measuring device, a Malvern Mastersizer 2000 was used. The powder was brought via a powder dispersing cell Scirocco 2000 into the laser light beam and the diffraction pattern was determined. From the diffraction pattern the particle size distribution was calculated.
GLP compliance:
yes (incl. QA statement)
Remarks:
GLP compliance programme (inspected on 11-12 October 2016 / signed on 28 February 2017)
Type of method:
Laser scattering/diffraction
Type of particle tested:
other: powder
Type of distribution:
volumetric distribution
Key result
Percentile:
D10
Mean:
1 µm
St. dev.:
0.006
Key result
Percentile:
D50
Mean:
9.4 µm
St. dev.:
0.1
Key result
Percentile:
D90
Mean:
82.8 µm
St. dev.:
3.3
No.:
#1
Size:
> 0 - < 4 µm
Distribution:
30.7 %
No.:
#2
Size:
> 0 - < 10 µm
Distribution:
51.5 %
No.:
#3
Size:
> 0 - < 100 µm
Distribution:
92.5 %
No.:
#4
Size:
> 0 - < 500 µm
Distribution:
100 %

Particle size distribution:

Two test series of 3 measurements each were performed with the test item.From each 3-fold measurement an average value was calculated.

The final result was calculated as mean value from the average values of the two samples. The test item showed a heterogeneous shape of the particles.

 

Test series 1

D10
(µm)

D50
(Median diameter, µm)

D90
(µm)

Test 1

1.000

9.351

79.110

Test 2

0.991

9.545

83.864

Test 3

0.989

9.512

85.335

Averaged

0.99

9.47

82.78

 

Test series 2

D10
(µm)

D50
(Median diameter, µm)

D90
(µm)

Test 1

0.970

9.317

78.731

Test 2

0.971

9.447

85.157

Test 3

0.969

9.390

84.749

Averaged

0.97

9.38

82.88

Average of both test series:

D10:         1.0 µm

D50:         9.4 µm (Median diameter)

D90:         82.8 µm

Test item was visually assessed via microscope (fivefold magnification) with correlative microscopy coverslip 10x10 grids of 0.1 mm squares.

In addition, the averaged results, the fraction distribution and the cumulative distribution of both test series are shown in the report.

The results in Volume % passing at 4, 10, 100 and 500 µm are reported as follows:

Particle size /µm

Volume under / %
Average 1

Volume under / %
Average 2

Volume under / %
Mean

4

30.57

30.89

30.7

10

51.39

51.59

51.5

100

92.46

92.52

92.5

500

100.00

100.00

100.0


 

Conclusions:
The test substance has a median particle size of D50 = 9.4 µm.
It contains 30.7%vol of particles < 4 µm (respirable fraction), 51.5%vol of particles < 10 µm (thoracic fraction) and 92.5%vol of particles < 100 µm (inhalable fraction).
Executive summary:

Particle size distribution of a sample of the substance was determined under GLP by laser diffraction measurement according to OECD/ISO/OCSPP standard methods.

Two independant determinations were conducted and the mean value was used to determine the particle size distribution of the substance.

Description of key information

The test substance has a median particle size of D50 = 9.4 µm.

It contains 30.7% vol of particles < 4 µm (respirable fraction), 51.5% vol of particles < 10 µm (thoracic fraction) and 92.5% vol of particles < 100 µm (inhalable fraction).

Additional information

A fully reliable GLP experimental study conducted according to recognized OECD/ISO/OCSPP guidelines using laser diffraction method, is available. It is considered as a key study, and the result is retained as key data.