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EC number: 828-215-2 | CAS number: 172796-84-8
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was conducted between 12 September 2018 and 17 November 2018.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
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
Test material
- Reference substance name:
- phosphonic acid, [2-(4-aminophenyl)-1-hydroxyethylidene]bis-, monosodium salt
- EC Number:
- 828-215-2
- Cas Number:
- 172796-84-8
- Molecular formula:
- C8H12NO7P2Na
- IUPAC Name:
- phosphonic acid, [2-(4-aminophenyl)-1-hydroxyethylidene]bis-, monosodium salt
- Reference substance name:
- 4-aminophenylacetic acid
- EC Number:
- 214-828-7
- EC Name:
- 4-aminophenylacetic acid
- Cas Number:
- 1197-55-3
- Molecular formula:
- C8H9NO2
- IUPAC Name:
- 4-aminophenylacetic acid
- Reference substance name:
- EBP dimer
- Molecular formula:
- C16H22N2O12P4
- IUPAC Name:
- EBP dimer
- Test material form:
- solid: particulate/powder
Constituent 1
impurity 1
impurity 2
- Specific details on test material used for the study:
- Identification: Phosphonic acid, [2-(4-aminophenyl)-1-hydroxyethylidene]bis-, monosodium salt (“EBP”)
Appearance/Physical state: Beige colored powder
Batch: CHPC071917EBP
Purity: >90%
Expiry date: 01 July 2019
Storage conditions: Room temperature in the dark
Results and discussion
- Remarks on result:
- not determinable
Particle size
- 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 size distribution at different passagesopen allclose all
- No.:
- #1
- Size:
- < 100 µm
- Distribution:
- 79.8 %
- No.:
- #2
- Size:
- < 10 µm
- Distribution:
- 0 %
- No.:
- #3
- Size:
- < 5.5 µm
- Distribution:
- 0 %
Any other information on results incl. tables
Sieve Screening Test
The results of the sieving procedure are shown in the following table:
Measurement |
Result |
Mass of test item transferred to sieve (W1) |
15.97 g |
Mass of test item passed through sieve (W3– W2) |
12.74 g |
Percentage of test item less than 100 µm |
79.8% |
Cascade Impactor
The results of the cascade impactor procedure are shown in the following table:
Collection Stage |
Particle Size Range Collected (µm) |
Collected Mass (g) |
||
Determination 1 |
Determination 2 |
Determination 3 |
||
Artificial throat |
n/a |
0.32 |
0.26 |
0.25 |
Sample Cup 1 |
≥10.0 |
2.6606 |
2.8023 |
2.7906 |
Sample Cup 2 |
≥5.5 to <10.0 |
0.0000 |
0.0000 |
0.0000 |
Sample Cup 3 |
≥2.4 to <5.5 |
0.0000 |
0.0000 |
0.0000 |
Sample Cup 4 |
≥1.61 to <2.4 |
0.0000 |
0.0000 |
0.0000 |
Sample Cup 5 |
≥0.307 to <1.61 |
0.0000 |
0.0000 |
0.0000 |
Final Filter |
<0.307 |
0.0000 |
0.0000 |
0.0000 |
Total mass of collected test item |
2.9806 |
3.0623 |
3.0406 |
|
Mass of test item added |
2.9878 |
3.0755 |
3.0344 |
|
The cumulative amounts of test item collected in the three determinations for the individual particle size cut-points are shown in the following table:
Particle Size Cut Points (µm) |
Cumulative Mass (g) |
Cumulative Percentage (%) |
||||
Determination 1 |
Determination 2 |
Determination 3 |
Determination 1 |
Determination 2 |
Determination 3 |
|
<10.0 |
0.0000 |
0.0000 |
0.0000 |
0.00 |
0.00 |
0.00 |
<5.5 |
0.0000 |
0.0000 |
0.0000 |
0.00 |
0.00 |
0.00 |
<2.4 |
0.0000 |
0.0000 |
0.0000 |
0.00 |
0.00 |
0.00 |
<1.61 |
0.0000 |
0.0000 |
0.0000 |
0.00 |
0.00 |
0.00 |
<0.307 |
0.0000 |
0.0000 |
0.0000 |
0.00 |
0.00 |
0.00 |
Mean
cumulative percentage with a particle size less than 10.0 µm : 0.00
Mean
cumulative percentage with a particle size less than 5.5 µm : 0.00
Applicant's summary and conclusion
- Conclusions:
- Particle size data acquired for the test item is shown in the following table:
Measurement Method Result
Percentage of test item with an inhalable particle size <100 µm Sieve 79.8%
Percentage of test item with a thoracic particle size <10.0 µm Cascade Impactor 0.0%
Percentage of test item with a respirable particle size <5.5 µm Cascade Impactor 0.0% - Executive summary:
Particle Size Distribution. Particle size data was acquired, using a procedure designed to be compatible with the European Commission Technical Guidance Document EUR 20268 Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances (2002). The results are as follows:
Measurement
Method
Result
Proportion of test item having an inhalable particle size <100 µm
Sieve
79.8%
Proportion of test item having a thoracic particle size <10.0 µm
Cascade Impactor
0.0%
Proportion of test item having a respirable particle size <5.5 µm
Cascade Impactor
0.0%
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