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EC number: 254-751-6 | CAS number: 40018-26-6
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-07-02 to 2004-11-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- 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:
- The method used is designed to comply with that given in ‘Particle Size Distribution, Fibre Length and Diameter Distribution’, June 1996 European Commission technical guidance document, which satisfies the requirements of OECD Guideline 110.
- Deviations:
- yes
- Remarks:
- a preliminary sieve test was followed by a determination with the cascade impactor method
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- cascade impaction
- Remarks:
- Screening test: sieve method; Definitive test: cascade impactor method
- Type of distribution:
- mass based distribution
Test material
- Reference substance name:
- 1,4-dithiane-2,5-diol
- EC Number:
- 254-751-6
- EC Name:
- 1,4-dithiane-2,5-diol
- Cas Number:
- 40018-26-6
- Molecular formula:
- C4H8O2S2
- IUPAC Name:
- 1,4-dithiane-2,5-diol
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: approximately 4°C, in the dark
Results and discussion
- Remarks on result:
- other:
- Remarks:
- A significant proportion (21.1%) of particles were found to be in the thoracic range (< 10.2 µm). However, there were too few to allow accurate assessment of mass median aerodynamic diameter.
Particle size
- Key result
- Percentile:
- other: Mean Proportion of particles in the thoracic range
- Mean:
- 21.1 other: %
- Remarks on result:
- other: Stadard deviation is not applicable
- Remarks:
- A significant proportion (21.1%) of particles were found to be in the thoracic range (<10.2 µm). However, there were too few to allow accurate assessment of mass median aerodynamic diameter.
Particle size distribution at different passagesopen allclose all
- No.:
- #2
- Size:
- 10.2 µm
- Distribution:
- 15.2 %
- Remarks on result:
- other: Number given for No. specifies Cup Number
- No.:
- #3
- Size:
- 5.4 µm
- Distribution:
- 3.61 %
- Remarks on result:
- other: Number given for No. specifies Cup Number
- No.:
- #4
- Size:
- 2.5 µm
- Distribution:
- 1.51 %
- Remarks on result:
- other: Number given for No. specifies Cup Number
- No.:
- #5
- Size:
- 1.67 µm
- Distribution:
- 0.964 %
- Remarks on result:
- other: Number given for No. specifies Cup Number
- No.:
- #6
- Size:
- 0.393 µm
- Distribution:
- 0.62 %
- Remarks on result:
- other: results for Filter
Any other information on results incl. tables
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) |
12.0 |
Mass of test material passed through sieve (g) |
1.9 |
Test material less than sieve aperture size (%) |
15.8 |
Definitive test (cascade impactor method)
The results of the cascade impactor method are shown in the following table:
Determination 1
Cup Number |
Particle Size Range |
Cup Masses (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
1 |
>10.2 |
86.8605 |
88.7111 |
1.8506 |
2 |
5.4 - 10.2 |
86.0529 |
86.5346 |
0.4817 |
3 |
2.5 - 5.4 |
86.3154 |
86.4053 |
0.0899 |
4 |
1.67 - 2.5 |
86.1372 |
86.1607 |
0.0235 |
5 |
0.393 - 1.67 |
86.1918 |
86.2025 |
0.0107 |
Filter |
<0.393 |
75.5593 |
75.6026 |
0.0433 |
Amount of test material found in artificial throat: 0.0 g.
Total amount of test material recovered from impactor cups, filter and artificial throat: 2.50 g.
The cumulative amounts found for the individual particle size cut-points (µm) are shown in the following table:
Determination 1
Cup Number |
Particle Size Cut-points |
Cumulative Mass of Test |
Cumulative Amount of |
2 |
10.2 |
0.6491 |
26.0 |
3 |
5.4 |
0.1674 |
6.70 |
4 |
2.5 |
0.0775 |
3.10 |
5 |
1.67 |
0.0540 |
2.16 |
Filter |
0.393 |
0.0433 |
1.73 |
Determination 2
Cup Number |
Particle Size Range |
Cup Masses (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
1 |
>10.2 |
86.8614 |
88.1852 |
1.3238 |
2 |
5.4 - 10.2 |
86.0517 |
86.2963 |
0.2446 |
3 |
2.5 - 5.4 |
86.3153 |
86.3580 |
0.0427 |
4 |
1.67 - 2.5 |
86.1375 |
86.1472 |
0.0097 |
5 |
0.393 - 1.67 |
86.1915 |
86.1971 |
0.0056 |
Filter |
<0.393 |
75.5648 |
75.5794 |
0.0146 |
Amount of test material found in artificial throat: 0.0 g.
Total amount of test material recovered from impactor cups, filter and artificial throat: 1.64 g.
The cumulative amounts found for the individual particle size cut-points (µm) are shown in the following table:
Determination 2
Cup Number |
Particle Size Cut-points |
Cumulative Mass of Test |
Cumulative Amount of |
2 |
10.2 |
0.3172 |
19.3 |
3 |
5.4 |
0.0726 |
4.42 |
4 |
2.5 |
0.0299 |
1.82 |
5 |
1.67 |
0.0202 |
1.23 |
Filter |
0.393 |
0.0146 |
0.890 |
Determination 3
Cup Number |
Particle Size Range |
Cup Masses (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
1 |
>10.2 |
86.8591 |
88.7070 |
1.8479 |
2 |
5.4 - 10.2 |
86.0509 |
86.3130 |
0.2621 |
3 |
2.5 - 5.4 |
86.3139 |
86.3929 |
0.0790 |
4 |
1.67 - 2.5 |
86.1361 |
86.1546 |
0.0185 |
5 |
0.393 - 1.67 |
86.1894 |
86.2023 |
0.0129 |
Filter |
<0.393 |
75.5673 |
75.5962 |
0.0289 |
Amount of test material found in artificial throat = 0.0 g.
Total amount of test material recovered from impactor cups, filter and artificial throat = 2.25 g.
The cumulative amounts found for the individual particle size cut-points (µm) are shown in the following table:
Determination 3
Cup Number |
Particle Size Cut-points |
Cumulative Mass of Test |
Cumulative Amount of |
2 |
10.2 |
0.4014 |
17.8 |
3 |
5.4 |
0.1393 |
6.19 |
4 |
2.5 |
0.0603 |
2.68 |
5 |
1.67 |
0.0418 |
1.86 |
Filter |
0.393 |
0.0289 |
1.29 |
Determination 4
Cup Number |
Particle Size Range |
Cup Masses (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
1 |
>10.2 |
86.8557 |
88.5836 |
1.7279 |
2 |
5.4 - 10.2 |
86.0469 |
86.5248 |
0.4779 |
3 |
2.5 - 5.4 |
86.3116 |
86.3983 |
0.0867 |
4 |
1.67 - 2.5 |
86.1342 |
86.1542 |
0.0200 |
5 |
0.393 - 1.67 |
86.1889 |
86.1979 |
0.0090 |
Filter |
<0.393 |
75.5533 |
75.5967 |
0.0434 |
Amount of test material found in artificial throat = 0.0 g.
Total amount of test material recovered from impactor cups, filter and artificial throat = 2.36 g.
The cumulative amounts found for the individual particle size cut-points (µm) are shown in the following table:
Determination 4
Cup Number |
Particle Size Cut-points |
Cumulative Mass of Test |
Cumulative Amount of |
2 |
10.2 |
0.6370 |
26.9 |
3 |
5.4 |
0.1591 |
6.73 |
4 |
2.5 |
0.0724 |
3.06 |
5 |
1.67 |
0.0524 |
2.22 |
Filter |
0.393 |
0.0434 |
1.84 |
Determination 5
Cup Number |
Particle Size Range |
Cup Masses (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
1 |
>10.2 |
86.8521 |
89.0211 |
2.1690 |
2 |
5.4 - 10.2 |
86.0459 |
86.3566 |
0.3107 |
3 |
2.5 - 5.4 |
86.3101 |
86.3665 |
0.0564 |
4 |
1.67 - 2.5 |
86.1342 |
86.1487 |
0.0145 |
5 |
0.393 - 1.67 |
86.1856 |
86.1948 |
0.0092 |
Filter |
<0.393 |
75.5610 |
75.5776 |
0.0166 |
Amount of test material found in artificial throat = 0.1 g.
Total amount of test material recovered from impactor cups, filter and artificial throat = 2.68 g.
The cumulative amounts found for the individual particle size cut-points (µm) are shown in the following table:
Determination 5
Cup Number |
Particle Size Cut-points |
Cumulative Mass of Test |
Cumulative Amount of |
2 |
10.2 |
0.4074 |
15.2 |
3 |
5.4 |
0.0967 |
3.61 |
4 |
2.5 |
0.0403 |
1.51 |
5 |
1.67 |
0.0258 |
0.964 |
Filter |
0.393 |
0.0166 |
0.620 |
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 |
10.2 |
0.4074 |
15.2 |
3 |
5.4 |
0.0967 |
3.61 |
4 |
2.5 |
0.0403 |
1.51 |
5 |
1.67 |
0.0258 |
0.964 |
Filter |
0.393 |
0.0166 |
0.620 |
The overall cumulative amounts of test material with a particle size less than 10.2 µm (%) from Determinations 1 to 5 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 |
26.0 |
|
2 |
19.3 |
|
3 |
17.8 |
21.1 |
| 4 | 26.9 | |
| 5 | 15.2 |
Discussion
Due to the slight variation between the results of the first three determinations, an extra two were performed. As no definite trend was observed, all five were included in the mean result.
A significant proportion (21.1%) of particles were found to be in the thoracic range (<10.2 µm). However, there were too few 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 inhalation fraction is defined as the mass fraction of particles which can be inhaled by nose or mouth and the thoracic fraction is defined as the mass fraction of particles that passes the larynx.
It was noted that a greater proportion of test material was found to be <10.2 µm than went through the 100 µm sieve. This probably due to partial blocking of the sieve with test material.
Applicant's summary and conclusion
- Conclusions:
- Particle size data acquired for the test material showed:
The proportion of test material having a particle size less than 100 µm , as determined by the sieve method, is 15.8%.
The proportion of test material having a particle size less than 10.2 µm, as determined by the Cascade Impactor method, is 21.1%.
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