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EC number: 700-777-2 | CAS number: -
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental Starting Date: 19 May 2012 Experimental Completion Date: 14 June 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
- Deviations:
- no
- Principles of method if other than guideline:
- The method used is based on a procedure designed to be compatible 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, 12 May 1981.
- GLP compliance:
- yes
- Type of method:
- determination of fibre length and diameter distributions
- Type of distribution:
- mass based distribution
Test material
- Reference substance name:
- lithium 3-((3,4-dicyanophenyl)sulfonyl)propane-1-sulfonate)
- EC Number:
- 700-777-2
- Cas Number:
- 667889-11-4
- Molecular formula:
- C11H9N2O5S2Li
- IUPAC Name:
- lithium 3-((3,4-dicyanophenyl)sulfonyl)propane-1-sulfonate)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Identification: S193308
Description: white powder
Batch: 422 (Bag 3)
Purity: 98.9%
Expiry / Retest Date: not applicable
Storage Conditions: room temperature in the dark
Constituent 1
Results and discussion
Particle size
- Remarks on result:
- not measured/tested
- Remarks:
- Mass median diameter not calculated
Particle size distribution at different passagesopen allclose all
- No.:
- #1
- Size:
- < 100 µm
- Distribution:
- ca. 52.4 %
- No.:
- #2
- Size:
- < 10 µm
- Distribution:
- ca. 0.136 %
- No.:
- #3
- Size:
- < 5.5 µm
- Distribution:
- 0.044 %
Any other information on results incl. tables
Results
Screening test (sieve method)
The results of the sieving procedure are shown in the following table:
Table 3.1
Measurement |
Result |
Mass of test item transferred to sieve |
15.87g |
Mass of test item passed through sieve |
8.31g |
Proportion of test item <100 µm |
52.4% |
Definitive test (cascade impactor method)
The results of the cascade impactor method determinations are shown as follows:
Determination 1
Table 3.2
Collection Stage |
Particle Size Range Collected (µm) |
Mass (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
Cup 1 |
>10.0 |
86.1112 |
88.3643 |
2.2531 |
Cup 2 |
5.5 to 10.0 |
85.5525 |
85.5601 |
0.0076 |
Cup 3 |
2.4 to 5.5 |
85.9041 |
85.9068 |
0.0027 |
Cup 4 |
1.61 to 2.4 |
85.6842 |
85.6847 |
0.0005 |
Cup 5 |
0.307 to 1.61 |
85.8538 |
85.8542 |
0.0004 |
Filter |
<0.307 |
75.5156 |
75.5156 |
0.0000 |
Mass of test item found in artificial
throat: 0.87 g.
Total mass of test item recovered from artificial throat, sample cups
and filter: 3.1343g.
Determination 2
Table 3.3
Collection Stage |
Particle Size Range Collected (µm) |
Mass (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
Cup 1 |
>10.0 |
86.1133 |
88.4399 |
2.3266 |
Cup 2 |
5.5 to 10.0 |
85.5540 |
85.5647 |
0.0107 |
Cup 3 |
2.4 to 5.5 |
85.9049 |
85.9079 |
0.0030 |
Cup 4 |
1.61 to 2.4 |
85.6837 |
85.6852 |
0.0015 |
Cup 5 |
0.307 to 1.61 |
85.8543 |
85.8544 |
0.0001 |
Filter |
<0.307 |
75.5174 |
75.5175 |
0.0001 |
Mass of test item found in artificial
throat: 0.64 g.
Total mass of test item recovered from artificial throat, sample cups
and filter: 2.9820 g
Determination 3
Table 3.4
Collection Stage |
Particle Size Range Collected (µm) |
Mass (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
Cup 1 |
>10.0 |
86.1109 |
87.8134 |
1.7025 |
Cup 2 |
5.5 to 10.0 |
85.5528 |
85.5580 |
0.0052 |
Cup 3 |
2.4 to 5.5 |
85.9046 |
85.9073 |
0.0027 |
Cup 4 |
1.61 to 2.4 |
85.6839 |
85.6846 |
0.0007 |
Cup 5 |
0.307 to 1.61 |
85.8543 |
85.8549 |
0.0006 |
Filter |
<0.307 |
75.5148 |
75.5149 |
0.0001 |
Mass of test item found in artificial
throat: 1.33 g.
Total mass of test item recovered from artificial throat, sample cups
and filter: 3.0418 g.
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:
Table 3.5
Particle Size Cut-point (µm) |
Cumulative Mass (g) |
Cumulative Percentage (%) |
||||
Determination 1 |
Determination 2 |
Determination 3 |
Determination 1 |
Determination 2 |
Determination 3 |
|
10.0 |
0.0112 |
0.0154 |
0.0093 |
0.357 |
0.516 |
0.306 |
5.5 |
0.0036 |
0.0047 |
0.0041 |
0.115 |
0.158 |
0.135 |
2.4 |
0.0009 |
0.0017 |
0.00014 |
2.871 x 10-2 |
5.701 x 10-2 |
4.603 x 10-2 |
1.61 |
0.0004 |
0.0002 |
0.0007 |
1.276 x 10-2 |
6.707 x10-3 |
2.301 x 10-2 |
0.307 |
0.0000 |
0.0001 |
0.0001 |
0.000 |
3.535 x 10-3 |
3.288 x 10-3 |
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:
Table 3.6
Particle size |
Cumulative Percentage (%) |
|||
Determination 1 |
Determination 2 |
Determination 3 |
Mean |
|
<10.0 µm |
0.115 |
0.158 |
0.135 |
0.136 |
<5.5 µm |
2.871 x 10-2 |
5.701 x 10-2 |
4.603 x 10-2 |
4.392 x 10-2 |
Applicant's summary and conclusion
- Conclusions:
- Please see the Executive Summary for the Conclusion section of the report.
- Executive summary:
The method used is based on a procedure designed to be compatible 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, 12 May 1981.
Conclusion
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
52.4%
Proportion of test item having a thoracic particle size <10.0 µm
Cascade Impactor
0.136%
Proportion of test item having a respirable particle size <5.5 µm
Cascade Impactor
4.39 x 10-2%
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