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EC number: 700-426-3 | CAS number: 502962-81-4
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 March 2010 to 16 March 2010
- 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:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
- Version / remarks:
- guideline followed
- Deviations:
- no
- Principles of method if other than guideline:
- guideline followed
- GLP compliance:
- yes (incl. QA statement)
- Type of distribution:
- other:
Test material
- Reference substance name:
- LiTOFA
- IUPAC Name:
- LiTOFA
- Details on test material:
- Sponsor's identification: LiTOFA
Description: off white solid
Batch number: SF 173
Expiry date: 21 January 2012
Date received: 21 January 2010
Storage conditions: room temperature in the dark
Constituent 1
Results and discussion
Particle sizeopen allclose all
- Percentile:
- D50
- Mean:
- other:
- Remarks on result:
- other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
- Mean:
- other:
- Remarks on result:
- other: Not applicable
Particle size distribution at different passagesopen allclose all
- No.:
- #1
- Size:
- < 100 other: µm
- Distribution:
- 17.4 %
- No.:
- #2
- Size:
- < 10 other: µm
- Distribution:
- 0.127 %
- No.:
- #3
- Size:
- < 5.5 other: µm
- Distribution:
- 0.043 %
Any other information on results incl. tables
Results
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 |
12.33 g |
Mass of test item passed through sieve |
2.14 g |
Proportion of test item <100 µm |
17.4 % |
Definitive test (cascade impactor method)
The results of the cascade impactor method determinations are shown as follows:
Determination1
Collection Stage |
ParticleCollected (µm) |
Masses (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
Cup 1 |
>10.0 |
86.1248 |
89.0081 |
2.8833 |
Cup 2 |
5.5 to 10.0 |
85.6309 |
85.6309 |
0.0000 |
Cup 3 |
2.4 to 5.5 |
86.0722 |
86.0724 |
0.0002 |
Cup 4 |
1.61 to 2.4 |
85.7852 |
85.7853 |
0.0001 |
Cup 5 |
0.307 to 1.61 |
85.9348 |
85.9342 |
-0.0006 |
Filter |
<0.307 |
75.6477 |
75.6478 |
0.0001 |
Mass of test item found in artificial
throat: 0.20 g
Total mass of test item recovered from artificial throat, sample cups
and filter:
3.0831 g
Determination 2
Collection Stage |
ParticleCollected (µm) |
Masses (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
Cup 1 |
>10.0 |
86.1245 |
87.0634 |
0.9398 |
Cup 2 |
5.5 to 10.0 |
85.6303 |
85.6344 |
0.0041 |
Cup 3 |
2.4 to 5.5 |
86.0723 |
86.0721 |
-0.0002 |
Cup 4 |
1.61 to 2.4 |
85.7847 |
85.7841 |
-0.0006 |
Cup 5 |
0.307 to 1.61 |
85.9348 |
85.9340 |
-0.0008 |
Filter |
<0.307 |
75.6464 |
75.6453 |
-0.0011 |
Mass of test item found in artificial
throat: 2.29 g
Total mass of test item recovered from artificial throat, sample cups
and filter:
3.2303 g
Determination 3
Collection Stage |
ParticleCollected (µm) |
Masses (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
Cup 1 |
>10.0 |
86.1249 |
88.0235 |
1.8986 |
Cup 2 |
5.5 to 10.0 |
85.6301 |
85.6305 |
0.0004 |
Cup 3 |
2.4 to 5.5 |
86.0720 |
86.0713 |
-0.0007 |
Cup 4 |
1.61 to 2.4 |
85.7849 |
85.7841 |
-0.0008 |
Cup 5 |
0.307 to 1.61 |
85.9339 |
85.9336 |
-0.0003 |
Filter |
<0.307 |
75.6468 |
75.6481 |
0.0013 |
Mass of test item found in artificial
throat: 1.11 g.
Total mass of test item recovered from artificial throat, sample cups
and filter:
3.0085 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 |
0.0004 |
0.0041 |
0.0017 |
1.30 x 10-2 |
0.127 |
5.65 x 10-2 |
5.5 |
0.0004 |
0.0000 |
0.0013 |
1.30 x 10-2 |
none detected |
4.321 x 10-2 |
2.4 |
0.0002 |
0.0000 |
0.0013 |
6.49 x 10-3 |
none detected |
4.321 x 10-2 |
1.61 |
0.0001 |
0.0000 |
0.0013 |
3.24 x 10-3 |
none detected |
4.321 x 10-2 |
0.307 |
0.0001 |
0.0000 |
0.0013 |
3.24 x 10-3 |
none detected |
4.321 x 10-2 |
*Where the post-sampling weight is greater than the pre-sampling weight resulting in a negative difference value (see tables 7.3, 7.4 and 7.5), a difference value of 0 has been used to calculate the cumulative mass and cumulative percentage.
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 |
|
<10.0 µm |
1.30 x 10-2 |
0.127 |
5.65 x 10-2 |
<5.5 µm |
1.30 x 10-2 |
None detected |
4.321 x 10-2 |
Applicant's summary and conclusion
- Conclusions:
- 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 17.4 %
Proportion of test item having a thoracic particle size <10.0 µm Cascade Impactor 0.127 %
Proportion of test item having a respirable particle size <5.5 µm Cascade Impactor 4.321 x 10-2% - Executive summary:
Particle size data has 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 requirents of OECD Guideline 110. The results are as follows:
Measurement
Method
Result
Proportion of test item having an inhalable particle size less than 100 µm
Sieve
17.4%
Proportion of test item having a thoracic particle size less than 10.0 µm
Cascade Impactor
0.127%
Proportion of test item having a respirable particle size less than 5.5 µm
Cascade Impactor
4.321 x 10-2%
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