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Particle size distribution (Granulometry)

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Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 May 2010 to 27 May 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Sponsor's identification: Great Lakes CD-75P
Description: White powder
Purity: 99.0%
Batch number: 609062G1
Date received: 30 April 2010
Expiry date: 02 March 2014
Storage conditions: room temperature, in the dark

Results and discussion

Particle size
Percentile:
D50
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.

Any other information on results incl. tables

Screening test (sieve method)

The results of the sieving procedure are shown in the following table:

Table 4.2. Results of sieve method study.

Measurement Result
Mass of test item transferred to sieve 18.05 g
Mass of test item passed through sieve 10.44 g
Proportion of test item <100 µm 57.8 %

Definitive test (cascade impactor method).

The results of the cascade impactor method determinations are shown as follows:

Table 4.3. Determination 1

Collection Stage Particle Size Range Collected (µm) Mass
Pre-sampling Post-sampling Difference
Cup 1 >10.0 86.3229 87.8807 1.5578
Cup 2 5.5 to 10.0 85.7403 85.8267 0.0864
Cup 3 2.4 to 5.5 86.1827 86.1929 0.0102
Cup 4 1.61 to 2.4 85.9157 85.9169 0.0012
Cup 5 0.307 to 1.61 86.0549 86.0579 0.0030
Filter <0.307 75.6513 75.6528 0.0015

Mass of test item found in artificial throat: 1.23g

Total mass of test item recovered from artificial throat, sample cups and filter: 2.8901g

Table 4.4. Determination 2

Collection Stage Particle Size Range Collected (µm) Mass
Pre-sampling Post-sampling Difference
Cup 1 >10.0 86.3242 88.4322 2.1080
Cup 2 5.5 to 10.0 85.7405 85.7836 0.0431
Cup 3 2.4 to 5.5 86.1847 86.1899 0.0052
Cup 4 1.61 to 2.4 85.9158 85.9164 0.0006
Cup 5 0.307 to 1.61 86.0533 86.0579 0.0046
Filter <0.307 75.6464 75.6484 0.0020

Mass of test item found in artificial throat: 0.79g

Total mass of test item recovered from artificial throat, sample cups and filter: 2.9535g

Table 4.5. Determination 3

Collection Stage Particle Size Range Collected (µm) Mass
Pre-sampling Post-sampling Difference
Cup 1 >10.0 86.3254 88.6569 2.3315
Cup 2 5.5 to 10.0 85.7448 85.8363 0.0915
Cup 3 2.4 to 5.5 86.1850 86.1949 0.0099
Cup 4 1.61 to 2.4 85.9153 85.9172 0.0019
Cup 5 0.307 to 1.61 86.0583 86.0595 0.0012
Filter <0.307 75.6492 75.6508 0.0016

Mass of test item found in artificial throat: 0.53g

Total mass of test item recovered from artificial throat, sample cups and filter: 2.9679g

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:

Table 4.6. Cumulative amounts.

Particle Size
Cut-point (µm)
Cumulative Mass (g) Cumulative Percentage (%)
Determination 1 Determination 2 Determination 3 Determination 1 Determination 2 Determination 3
10 0.1023 0.0555 0.1061 3.54 1.88 3.58
5.5 0.0159 0.0124 0.0146 0.55 0.42 0.49
2.4 0.0057 0.0072 0.0047 0.20 0.24 0.16
1.61 0.0045 0.0066 0.0028 0.16 0.22 0.09
0.307 0.0015 0.0020 0.0016 0.05 0.07 0.05

The overall cumulative percentage (%) of test item with a particle size less than 10.0µm and 5.5µm are shown in the following table:

Table 4.7. Mean particle size <10.0µm and <5.5µm.

Particle Size
Cut-point (µm)
Cumulative Percentage (%) Mean
Determination 1 Determination 2 Determination 3
<10 3.54 1.88 3.58 3.00
<5.5 0.55 0.42 0.49 0.49

Discussion

Too few particles were of a size less than 10.0µm to allow accurate assessment of the mass median aerodynamic diameter.

Sampling for the cascade impactor determinations was performed by rolling the test item container for approximately 10 minutes them sampled from the top, middle and bottom.

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.

Applicant's summary and conclusion

Conclusions:
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 57.8%
Proportion of test item having a thoracic particle size <10.0 µm Cascade Impactor 3.00%
Proportion of test item having a respirable particle size <5.5 µm Cascade Impactor 0.49%
Executive summary:

Particle size data have been acquired using a procedure designed to comply with the EC technical guidance document 'Particle Size Distribution, Fibre Length and Diameter Distribution' (June, 1996), which satisfies the requirements of OECD Guideline 110. The results are as follows:

Measurement                                                                                        Method                           Result

Proportion of test item having an inhalable particle size <100 µm               Sieve                                 57.8 %

Proportion of test item having an thoracic particle size of < 10 µm             Cascade impactor              3.0 %

Propotion of test item having a respirable particle size of <5.5 µm            Cascade impactor              0.49%