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EC number: 936-610-7 | CAS number: -
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:
- 24 April 2008 and 19 September 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with GLP and agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC JRC Guidance Document on the Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substance
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of Signature: 15/10/2007; Date of Inspection: 21/08/2007
- Type of method:
- cascade impaction
- Remarks:
- with a sieve method screening test
- Type of distribution:
- volumetric distribution
- Remarks on result:
- not determinable
- Remarks:
- Too few particles were of a size < 10.0 µm to allow accurate assessment of mass median aerodynamic diameter
- No.:
- #1
- Size:
- < 100 µm
- Distribution:
- 77.1 %
- No.:
- #2
- Size:
- < 10 µm
- Distribution:
- 1.81 %
- No.:
- #3
- Size:
- < 5.5 µm
- Distribution:
- 0.463 %
- Conclusions:
- Particle size data acquired for the test material are shown below:
Proportion of test material having an inhalable particle size less than 100 µm: 77.1 % (Sieve method)
Proportion of test material having a thoracic particle size less than 10.0 µm: 1.81 % (Cascade Impactor method)
Proportion of test material having a respirable particle size less than 5.5 µm: 0.463 % (Cascade Impactor method) - Executive summary:
The volumetric particle size distribution of the test material was determined using a method 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.
Particle size data acquired for the test material are shown in the following table:
Measurement
Method
Result
Proportion of test material having an inhalable particle size less than 100 µm
Sieve
77.1%
Proportion of test material having a thoracic particle size less than 10.0 µm
Cascade Impactor
1.81%
Proportion of test material having a respirable particle size less than 5.5 µm
Cascade Impactor
0.463%
Reference
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) |
10.94 |
Mass of test material passed through sieve (g) |
8.44 |
Test material less than sieve aperture size (%) |
77.1 |
Definitive test (cascade impactor method)
Determination 1
The results of the cascade impactor method are shown in the following table:
Determination 1
Cup Number |
ParticleCollected (µm) |
Cup Masses (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
1 |
>10.0 |
86.1395 |
88.8327 |
2.6932 |
2 |
5.5 - 10.0 |
85.4426 |
85.4860 |
0.0434 |
3 |
2.4 - 5.5 |
85.8855 |
85.8948 |
0.0093 |
4 |
1.61 - 2.4 |
85.5868 |
85.5908 |
0.0040 |
5 |
0.307 - 1.61 |
85.7493 |
85.7519 |
0.0026 |
Filter |
<0.307 |
75.1227 |
75.1245 |
0.0018 |
Amount of test material found in artificial throat:
0.11 g.
Total amount of test material recovered from impactor cups, filter and
artificial throat: 2.8643 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 (µm) |
Cumulative Mass of Test Material (g) |
Cumulative Amount of Test Material (%) |
2 |
10.0 |
0.0611 |
2.13 |
3 |
5.5 |
0.0177 |
0.618 |
4 |
2.4 |
0.0084 |
0.293 |
5 |
1.61 |
0.0044 |
0.154 |
Filter |
0.307 |
0.0018 |
6.28 x 10-2 |
Determination 2
The results of the cascade impactor method are shown in the following table:
Determination 2
Cup Number |
ParticleCollected (µm) |
Cup Masses (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
1 |
>10.0 |
86.1113 |
88.9036 |
2.7923 |
2 |
5.5 - 10.0 |
85.4474 |
85.4906 |
0.0432 |
3 |
2.4 - 5.5 |
85.8807 |
85.8893 |
0.0086 |
4 |
1.61 - 2.4 |
85.6019 |
85.6047 |
0.0028 |
5 |
0.307 - 1.61 |
85.7342 |
85.7358 |
0.0016 |
Filter |
<0.307 |
75.1130 |
75.1154 |
0.0024 |
Amount of test material found in artificial throat:
0.14 g.
Total amount of test material recovered from impactor cups, filter and
artificial throat: 2.9909 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 (µm) |
Cumulative Mass of Test Material (g) |
Cumulative Amount of Test Material (%) |
2 |
10.0 |
0.0586 |
1.96 |
3 |
5.5 |
0.0154 |
0.515 |
4 |
2.4 |
0.0068 |
0.227 |
5 |
1.61 |
0.0040 |
0.134 |
Filter |
0.307 |
0.0024 |
8.02 x 10-2 |
Determination 3
The results of the cascade impactor method are shown in the following table:
Determination 3
Cup Number |
Particle Collected (µm) |
Cup Masses (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
1 |
>10.0 |
86.1210 |
88.9876 |
2.8666 |
2 |
5.5 - 10.0 |
85.4231 |
85.4549 |
0.0318 |
3 |
2.4 - 5.5 |
85.8856 |
85.8910 |
0.0054 |
4 |
1.61 - 2.4 |
85.5985 |
85.5991 |
0.0006 |
5 |
0.307 - 1.61 |
85.7456 |
85.7456 |
0 |
Filter |
<0.307 |
75.1085 |
75.1100 |
0.0015 |
Amount of test material found in artificial throat:
0.04 g.
Total amount of test material recovered from impactor cups, filter and
artificial throat: 2.9459 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 (µm) |
Cumulative Mass of Test Material (g) |
Cumulative Amount of Test Material (%) |
2 |
10.0 |
0.0393 |
1.33 |
3 |
5.5 |
0.0075 |
0.255 |
4 |
2.4 |
0.0021 |
7.13 x 10-2 |
5 |
1.61 |
0.0015 |
5.09 x 10-2 |
Filter |
0.307 |
0.0015 |
5.09 x 10-2 |
The overall cumulative amounts of test material with a particle size less than 10.0 µm (%) from Determinations 1 to 3 are shown in the following table:
Determination |
Cumulative Amount of Test Material Less Than 10.0 µm (%) |
Mean Cumulative Amount of Test Material Less Than 10.0 µm (%) |
1 |
2.13 |
1.81 |
2 |
1.96 |
|
3 |
1.33 |
The overall cumulative amounts of test material with a particle size less than 5.5 µm (%) from Determinations 1 to 3 are shown in the following table:
Determination |
Cumulative Amount of Test Material Less Than 5.5 µm (%) |
Mean Cumulative Amount of Test Material Less Than 5.5 µm (%) |
1 |
0.618 |
0.463 |
2 |
0.515 |
|
3 |
0.255 |
Discussion
Too few particles were of a size less than 10.0 µm 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 inhalable fraction is defined as the mass fraction of particles which can be inhaled by nose or mouth, the thoracic fraction is defined as the mass fraction of particles that passes the larynx and the respirable fraction is defined as the mass fraction of particles that reaches the alveoli.
Description of key information
Proportion of test material having an inhalable particle size less than 100 µm: 77.1 %, Proportion of test material having a thoracic particle size less than 10.0 µm: 1.81 %, Proportion of test material having a respirable particle size less than 5.5 µm: 0.463 %, equivalent to OECD 110, Butler & White (2008)
Additional information
In the key study (Butler and White, 2008) the volumetric particle size distribution of the test material was determined in a method in line with the technical guidance EC JRC Guidance Document on the Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substance which satisfies the data requirements for the method OECD 110. The study was performed using sieving and a cascade impactor. The study was performed under GLP conditions. The study was assigned a reliability score of 1 in accordance with the principles for assessing data quality outlined in Klimisch et al. (1997).
Under the conditions of the test, the particle size data acquired for the test material are:
Proportion of test material having an inhalable particle size less than 100 µm: 77.1 % (Sieve method)
Proportion of test material having a thoracic particle size less than 10.0 µm: 1.81 % (Cascade Impactor method)
Proportion of test material having a respirable particle size less than 5.5 µm: 0.463 % (Cascade Impactor method).
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