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EC number: 214-060-2 | CAS number: 1076-38-6
Particle size distribution (Granulometry)
Administrative data
Link to relevant study record(s)
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experiment start date - 06 November 2020; Experiment end date - 22 January 2021.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- Type of method:
- cascade impaction
- Specific details on test material used for the study:
- Identification: 4-Hydroxycoumarin
CAS Number: 1076-38-6
Appearance/Physical State: Beige powder
Batch Number: HCN20002
Purity: > 99%
Expiry Date: 26 September 2022
Storage Conditions: Room temperature, in the dark - No.:
- #1
- Size:
- < 100 µm
- Distribution:
- 95.1 %
- Remarks on result:
- other: Sieving method
- No.:
- #2
- Size:
- < 10 µm
- Distribution:
- <= 0.674 %
- Remarks on result:
- other: Cascade impactor
- No.:
- #3
- Size:
- < 5.5 µm
- Distribution:
- <= 0.187 %
- Remarks on result:
- other: Cascade impactor
- Conclusions:
- Proportion of test item having an inhalable particle size <100 µm (Sieve method): 95.1%
Proportion of test item having a thoracic particle size <10.0 µm (Cascade Impactor): ≤ 0.674%
Proportion of test item having a respirable particle size <5.5 µm (Cascade Impactor): ≤ 0.187% - Executive summary:
The particle size distribution of the test subtance was evaluated in a study conducted according to European Commission Guidance Document EUR 20268 'Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances' (2002).
Seiving method and Cascade impaction method was used for this purpose.
The results are as follows:
Measurement
Method
Result
Proportion of test item having an inhalable particle size <100 µm
Sieve
95.1%
Proportion of test item having a thoracic particle size <10.0 µm
Cascade Impactor
≤ 0.674%
Proportion of test item having a respirable particle size <5.5 µm
Cascade Impactor
≤ 0.187%
Reference
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) |
11.90 g |
Mass of test item passed through sieve (W3– W2) |
11.32 g |
Percentage of test item less than 100 µm |
95.1% |
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 |
0.25 |
0.28 |
0.16 |
Sample Cup 1 |
>10.0 |
2.6235 |
2.6773 |
2.8583 |
Sample Cup 2 |
5.5 to 10.0 |
0.0141 |
0.0101 |
0.0006 |
Sample Cup 3 |
2.4 to 5.5 |
0.0031 |
0.0008 |
0.0009 |
Sample Cup 4 |
1.61 to 2.4 |
0.0016 |
0.0002 |
0.0006 |
Sample Cup 5 |
0.307 to 1.61 |
0.0004 |
0.0003 |
0.0009 |
Final Filter |
<0.307 |
0.0003 |
0.0000 |
0.0000 |
Total mass of collected test item |
2.8930 |
2.9687 |
3.0213 |
|
Mass of test item added |
2.9412 |
2.9836 |
3.0058 |
|
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 |
0.0195 |
0.0114 |
0.0030 |
0.674 |
0.384 |
0.099 |
<5.5 |
0.0054 |
0.0013 |
0.0024 |
0.187 |
0.044 |
0.079 |
<2.4 |
0.0023 |
0.0005 |
0.0015 |
0.080 |
0.017 |
0.050 |
<1.61 |
0.0007 |
0.0003 |
0.0009 |
0.024 |
0.010 |
0.030 |
<0.307 |
0.0003 |
0.0000 |
0.0000 |
0.010 |
0.000 |
0.000 |
Overall cumulative percentage with a particle size less than 10.0 µm: ≤ 0.674
Overall cumulative percentage with a particle size less than 5.5 µm: ≤ 0.187
Description of key information
The particle size distribution of the test subtance was evaluated in a study conducted according to European Commission Guidance Document EUR 20268 'Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances' (2002).
Seiving method and Cascade impaction method was used for this purpose.
The results are as follows:
Measurement |
Method |
Result |
Proportion of test item having an inhalable particle size <100 µm |
Sieve |
95.1% |
Proportion of test item having a thoracic particle size <10.0 µm |
Cascade Impactor |
≤ 0.674% |
Proportion of test item having a respirable particle size <5.5 µm |
Cascade Impactor |
≤ 0.187% |
Additional information
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