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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:
2 August 2006 to 8 December 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions) - Method B: Fibre Length and Diameter Distributions
Version / remarks:
Cascade impactor
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
cascade impaction
Type of distribution:
volumetric distribution
Percentile:
D50
Remarks on result:
other: Standard deviation not reported.
No.:
#2
Size:
10 µm
Distribution:
0.741 %
Remarks on result:
other: Mean Cumulative Amount of Test Material Less Than 10.0 µm (%)
No.:
#3
Size:
5.5 µm
Distribution:
0.05 %
Remarks on result:
other: Mean Cumulative Amount of Test Material Less Than 5.5 µm (%)

Screening test (sieve method)

The results of the sieving procedure are shown in the following table:

 

Sieve aperture size (µm)

100

Mass of test material transferred to sieve (g)

10.10

Mass of test material passed through sieve (g)

1.58

Test material less than sieve aperture size (%)

15.6

 

Determination 1

 

Amount of test material found in artificial throat: 0.23 g.

Total amount of test material recovered from impactor cups, filter and artificial throat: 3.4870 g.

The cumulative amounts found for the individual particle size cut-points (µm) are shown in the following table:

 

Cup Number

Particle Size Cut-points (µm)

Cumulative Mass of Test Material (g)

Cumulative Amount of Test Material (%)

2

10.0

0.0373

1.07

3

5.5

0.0027

0.08

4

2.4

0.0005

0.01

5

1.61

0.0002

0.01

Filter

0.307

0.0001

<0.01

 

 

Determination 2

 

Amount of test material found in artificial throat: 0.24 g.

Total amount of test material recovered from impactor cups, filter and artificial throat: 3.0880 g.

The cumulative amounts found for the individual particle size cut-points (µm) are shown in the following table:

 

Cup Number

Particle Size Cut-points (µm)

Cumulative Mass of Test Material (g)

Cumulative Amount of Test Material (%)

2

10.0

0.0160

0.518

3

5.5

0.0009

0.03

4

2.4

0.0002

0.01

5

1.61

0.0000

0.00

Filter

0.307

0.0000

0.00

 

 

Determination 3

 

Amount of test material found in artificial throat: 0.44 g.

Total amount of test material recovered from impactor cups, filter and artificial throat: 2.8563 g.

The cumulative amounts found for the individual particle size cut-points (µm) are shown in the following table:

 

Cup Number

Particle Size Cut-points (µm)

Cumulative Mass of Test Material (g)

Cumulative Amount of Test Material (%)

2

10.0

0.0181

0.634

3

5.5

0.0010

0.04

4

2.4

0.0002

0.01

5

1.61

0.0003

0.01

Filter

0.307

0.0001

<0.01

 

 

 

The overall cumulative amounts of test material with a particle size less than 10.0 µm (%) from Determinations 1 to 3 are shown in the following table:

 

Determination

Cumulative Amount of Test Material Less Than 10 µm (%)

Mean Cumulative Amount of Test Material Less Than 10 µm (%)

1

1.07

0.741

2

0.518

3

0.634

 

 

The overall cumulative amounts of test material with a particle size less than 5.5 µm (%) from Determinations 1 to 3 are shown in the following table:

 

Determination

Cumulative Amount of Test Material Less Than 5.5 µm (%)

Mean Cumulative Amount of Test Material Less Than 5.5 µm (%)

1

0.08

0.05

2

0.03

3

0.04

 

 

Too few particles were of a size less than 10.0 µm to allow accurate assessment of mass median aerodynamic diameter.

Representative sampling was ensured by rolling the sample container for approximately 10 minutes and sampling from the top, middle and bottom prior to definitive testing.

The inhalable fraction is defined as the mass fraction of particles which can be inhaled by nose or mouth, the thoracic fraction is defined as the mass fraction of particles that passes the larynx and the respirable fraction is defined as the mass fraction of particles that reaches the alveoli.

Conclusions:
Particle size data acquired for the test material are as follows:
Proportion of test material having an inhalable particle size less than 100 µm (sieve method): 15.6%
Proportion of test material having a thoracic particle size less than 10.0 µm (cascade impactor method): 0.741%
Proportion of test material having a respirable particle size less than 5.5 µm (cascade impactor method): 0.05%
Executive summary:

In a general physico-chemical properties study (0370/0351), conducted according to OECD Test Method 110, the particle size distribution data of the test material was found to be as follows:

Proportion of test material having an inhalable particle size less than 100 µm (sieve method): 15.6%

Proportion of test material having a thoracic particle size less than 10.0 µm (cascade impactor method): 0.741%

Proportion of test material having a respirable particle size less than 5.5 µm (cascade impactor method): 0.05%

Description of key information

Particle size data acquired for the test material are as follows:

Proportion of test material having an inhalable particle size less than 100 µm (sieve method): 15.6 %

Proportion of test material having a thoracic particle size less than 10.0 µm (cascade impactor method): 0.741 %

Proportion of test material having a respirable particle size less than 5.5 µm (cascade impactor method): 0.05 %

Additional information

In a general physico-chemical properties study (0370/0351), conducted according to OECD Test Method 110, the particle size distribution data of the test material was found to be as follows:

Proportion of test material having an inhalable particle size less than 100 µm (sieve method): 15.6 %

Proportion of test material having a thoracic particle size less than 10.0 µm (cascade impactor method): 0.741 %

Proportion of test material having a respirable particle size less than 5.5 µm (cascade impactor method): 0.05 %

The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).