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EC number: 247-148-4 | CAS number: 25637-99-4
Particle size distribution (Granulometry)
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:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Hexabromocyclododecane
- EC Number:
- 247-148-4
- EC Name:
- Hexabromocyclododecane
- Cas Number:
- 25637-99-4
- Molecular formula:
- C12H18Br6
- IUPAC Name:
- (1S,2S,5S,6S,9S,10S)-1,2,5,6,9,10-hexabromocyclododecane
- Reference substance name:
- Hexabromocyclodedecane
- IUPAC Name:
- Hexabromocyclodedecane
- 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
Constituent 1
Constituent 2
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%
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