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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 2010 to 11 June 2010
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)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
cascade impaction
Remarks on result:
not determinable
Percentile:
D50
Remarks on result:
other: Too few particles were of a size less than 10.0 µm to allow accurate assessment of the mass median aerodynamic diameter.
No.:
#1
Size:
< 100 µm
Distribution:
59.6 %
Remarks on result:
other: Sieve method
No.:
#2
Size:
< 10 µm
Distribution:
0.065 %
Remarks on result:
other: cascade impactor method
No.:
#3
Size:
< 5.5 µm
Distribution:
0.049 %
Remarks on result:
other: cascade impactor method

 Screening test (sieve method)

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

Measurement

Result

Mass of test item transferred to sieve

15.48 g

Mass of test item passed through sieve

9.22 g

Proportion of test item <100 µm

59.6 %


Definitive test (cascade impactor method)

The results of the cascade impactor method determinations are shown as follows:

Determination 1

Collection Stage

ParticleCollected (µm)

Mass (g)

Pre-sampling

Post-sampling

Difference

Cup 1

>10.0

86.4311

89.0490

2.6179

Cup 2

5.5 to 10.0

85.7428

85.7433

0.0005

Cup 3

2.4 to 5.5

86.1810

86.1812

0.0002

Cup 4

1.61 to 2.4

85.9172

85.9176

0.0001

Cup 5

0.307 to 1.61

86.0596

86.0598

0.0002

Filter

<0.307

75.6559

75.6564

0.0005

Mass of test item found in artificial throat: 0.37 g
Total mass of test item recovered from artificial throat, sample cups and filter: 2.9894 g

Determination 2

Collection Stage

ParticleCollected (µm)

Mass (g)

Pre-sampling

Post-sampling

Difference

Cup 1

>10.0

86.4342

89.4373

3.0031

Cup 2

5.5 to 10.0

85.7451

85.7457

0.0006

Cup 3

2.4 to 5.5

86.1801

86.1814

0.0013

Cup 4

1.61 to 2.4

85.9170

85.9170

0.0000

Cup 5

0.307 to 1.61

86.0603

86.0604

0.0001

Filter

<0.307

75.6572

75.6581

0.0009

Mass of test item found in artificial throat: 0.02 g
Total mass of test item recovered from artificial throat, sample cups and filter: 3.0260 g


Determination 3

Collection Stage

ParticleCollected (µm)

Mass (g)

Pre-sampling

Post-sampling

Difference

Cup 1

>10.0

86.4318

89.3667

2.9349

Cup 2

5.5 to 10.0

85.7435

85.7438

0.0003

Cup 3

2.4 to 5.5

86.1809

86.1817

0.0008

Cup 4

1.61 to 2.4

85.9170

85.9171

0.0001

Cup 5

0.307 to 1.61

86.0605

86.0607

0.0002

Filter

<0.307

75.6597

75.6597

0.0000

Mass of test item found in artificial throat: 0.01 g
Total mass of test item recovered from artificial throat, sample cups and filter: 2.9463 g

Cumulative amounts

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

Particle Size Cut-point (µm)

Cumulative Mass (g)

Cumulative Percentage (%)

Determination 1

Determination 2

Determination 3

Determination 1

Determination 2

Determination 3

10.0

0.0015

0.0029

0.0014

5.02 x 10-2

9.58 x 10-2

4.75 x 10-2

5.5

0.0010

0.0023

0.0011

3.35 x 10-2

7.60 x 10-2

3.73 x 10-2

2.4

0.0008

0.0010

0.0003

2.68 x 10-2

3.31 x 10-2

1.02 x 10-2

1.61

0.0007

0.0010

0.0002

2.34 x 10-2

3.31 x 10-2

6.79 x 10-3

0.307

0.0005

0.0009

0.0000

1.67 x 10-2

2.97 x 10-2

0.00

 


The overall cumulative percentage (%) of test item with a particle size less than 10.0 µm and 5.5 µm are shown in the following table:

Particle size

Cumulative Percentage (%)

Determination 1

Determination 2

Determination 3

Mean

<10.0 µm

5.02 x 10-2

9.58 x 10-2

4.75 x 10-2

6.45 x 10-2

<5.5 µm

3.35 x 10-2

7.60 x 10-2

3.73 x 10-2

4.89 x 10-2
Conclusions:
Proportion of test item having a thoracic particle size < 10.0 µm = 6.45 x 10^-2 %
Proportion of test item having a respirable particle size < 5.5 µm = 4.89 x 10^-2 %
Executive summary:

Particle size data have been acquired using a procedure designed to comply with the European Commission technical guidance docunt 'Particle Size Distribution, Fibre Length and Diater Distribution' (June 1996), which satisfies the requirents of OECD Guideline 110. The results are as follows:

Measurement

Method

Result

Proportion of test item having an inhalable particle size < 100 µm

Sieve

59.6 %

Proportion of test item having a thoracic particle size < 10.0 µm

Cascade Impactor

6.45 x 10-2 %

Proportion of test item having a respirable particle size < 5.5 µm

Cascade Impactor

4.89 x 10-2 %

Description of key information

Particle size data have been acquired using a procedure designed to comply with the European Commission technical guidance document 'Particle Size Distribution, Fibre Length and Diater Distribution' (June 1996), which satisfies the requirements of OECD Guideline 110.

Results:

Proportion of test item having a thoracic particle size < 10.0 µm = 6.45 x 10^-2 %

Proportion of test item having a respirable particle size < 5.5 µm = 4.89 x 10^-2 %

Additional information

A reliability rating of 1 was assigned to this study, according to the criteria of Klimisch, 1997 as the study was conducted in accordance with a recognised guideline and GLP.