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Diss Factsheets

Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experimental phase started 16th June 2016 and completed 15th Jan 2017
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002).
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
cascade impaction
Type of particle tested:
primary particle

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylidynetrimethanol
EC Number:
201-063-9
EC Name:
Ethylidynetrimethanol
Cas Number:
77-85-0
Molecular formula:
C5H12O3
IUPAC Name:
2-(hydroxymethyl)-2-methylpropane-1,3-diol
Test material form:
solid: granular

Results and discussion

Remarks on result:
not determinable
Remarks:
Too few particles were of a size less than 10.0 µm to allow accurate assessment of the mass median aerodynamic diameter.
Particle sizeopen allclose all
Key result
Percentile:
other: Proportion of test item having an inhalable particle size < 100 µm
Mean:
ca. 23.8 other: %
St. dev.:
0
Key result
Percentile:
other: Proportion of test item having a thoracic particle size < 10 µm
Mean:
ca. 12.5 other: %
St. dev.:
0
Key result
Percentile:
other: Proportion of test item having a respirable particle size < µm
Mean:
ca. 5.45 other: %
St. dev.:
0

Any other information on results incl. tables

Result

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

15.11 g

Mass of test item passed through sieve

3.59 g

Percentage of test item less than 100 µm

23.8%

Definitive test (cascade impactor method)

The results of the cascade impactor method determinations are shown as follow

Determination 1

Collection Stage

Particle Size Range Collected (µm)

Mass (g)

Pre-sampling

Post-sampling

Difference

Cup 1

>10.0

85.9817

88.3114

2.3297

Cup 2

5.5 to 10.0

85.4901

85.6831

0.1930

Cup 3

2.4 to 5.5

85.8394

85.8916

0.0522

Cup 4

1.61 to 2.4

85.6796

85.6830

0.0034

Cup 5

0.307 to 1.61

85.7968

85.8048

0.0080

Filter

<0.307

0.1190

0.2638

0.1448

Mass of test item found in artificial throat:0.05g
Total mass of test item recovered from artificial throat, sample cups and filter :2.7811g

Determination 2

Collection Stage

Particle Size Range Collected (µm)

Mass (g)

Pre-sampling

Post-sampling

Difference

Cup 1

>10.0

86.0205

88.3422

2.3217

Cup 2

5.5 to 10.0

85.4392

85.7177

0.2785

Cup 3

2.4 to 5.5

85.8472

85.8945

0.0473

Cup 4

1.61 to 2.4

85.6796

85.6855

0.0059

Cup 5

0.307 to 1.61

85.8033

85.8158

0.0125

Filter

<0.307

0.1201

0.2152

0.0951

Mass of test item found in artificial throat :0.07g
Total mass of test item recovered from artificial throat, sample cups and filter: 2.8310g

Determination 3

Collection Stage

Particle Size Range Collected (µm)

Mass (g)

Pre-sampling

Post-sampling

Difference

Cup 1

>10.0

86.0212

88.6053

2.5841

Cup 2

5.5 to 10.0

85.4916

85.6135

0.1219

Cup 3

2.4 to 5.5

85.8833

85.9092

0.0259

Cup 4

1.61 to 2.4

85.6448

85.6498

0.0050

Cup 5

0.307 to 1.61

85.7523

85.7600

0.0077

Filter

<0.307

0.1194

0.1720

0.0526

Mass of test item found in artificial throat:0.08g
Total mass of test item recovered from artificial throat, sample cups and filter :2.8772g

Cumulative amounts

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

Particle Size Cut-point (µm)

Cumulative Mass (g)

Cumulative Percentage (%)

1

2

3

1

2

3

10.0

0.4014

0.4393

0.2131

14.4

15.5

7.41

5.5

0.2084

0.1608

0.0912

7.49

5.68

3.17

2.4

0.1562

0.1135

0.0653

5.62

4.01

2.27

1.61

0.1528

0.1076

0.0603

5.49

3.80

2.10

0.307

0.1448

0.0951

0.0526

5.21

3.36

1.83

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

14.4

15.5

7.41

12.5

<5.5 µm

7.49

5.68

3.17

5.45


 

Applicant's summary and conclusion

Conclusions:
Particle size data acquired for the test item is shown in the following table:

Measurement Method Result
Proportion of test item having an inhalable particle size <100 µm Sieve 23.8%
Proportion of test item having a thoracic particle size <10.0 µm Cascade Impactor 12.5%
Proportion of test item having a respirable particle size <5.5 µm Cascade Impactor 5.45%