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EC number: 201-063-9 | CAS number: 77-85-0
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:
- 2 017
- 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
- 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
Constituent 1
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%
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