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EC number: 701-300-0 | 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:
- September 30, 2011 - December 7, 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Version / remarks:
- 2009
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 187 (Particle size analysis by laser diffraction)
- Principles of method if other than guideline:
- According to REACH Regulation (EC) No 1907/2006, Article 13(3), tests on substances shall be conducted in accordance with the test methods laid down in a Commission Regulation or in accordance with other international test methods recognised by the Commission or the Agency as being appropriate. No particle size distribution test method is laid down in the relevant Regulation (EC) No 440/2008. The international OECD 110 test guideline ‘Particle Size Distribution/FibreLength and Diameter Distributions’ dates from 1981 and describes two methods in detail; both methods have restrictions and are not applicable to the entire size range. ECHA’s document ‘Guidance on information requirements and Chemical SafetyAssessment-Chapter R.7a: Endpoint specific guidance’ stipulates that many methods are available for particle size measurements but none of them is applicable to the entire size range. ECHA’s guidance mentions the Laser scattering/diffraction as a method suitable for particles of all kind and makes reference to ISO 13320:2009.
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- Laser scattering/diffraction
- Type of particle tested:
- primary particle
- Type of distribution:
- volumetric distribution
- Specific details on test material used for the study:
- Relative density: 4.13
- Mass median aerodynamic diameter:
- 11.811 µm
- Geometric standard deviation:
- >= 1.992 - <= 2.022
- Remarks on result:
- other: MMAD is the mean of 5 measurements. GSD was calculated from d50/d15.78. The St.dev. in the table below is the population standard deviation [µm].
- Key result
- Percentile:
- D10
- Mean:
- 2.105 µm
- St. dev.:
- 0.04
- Key result
- Percentile:
- D50
- Mean:
- 5.812 µm
- St. dev.:
- 0.06
- Key result
- Percentile:
- D90
- Mean:
- 11.278 µm
- St. dev.:
- 0.09
- No.:
- #1
- Size:
- < 10 µm
- Distribution:
- 84.51 %
- Conclusions:
- According to ISO 13320:2009, CIPAC MT 187 and GLP principles the particle size distribution of the substance was determined using laser diffraction analysis (dry powder module). The median D50 was 5.812 µm; 90% of all particles were < 11.278 µm and 84.51% by volume of sample was seen to be < 10.00 μm. The MMAD was 11.811 μm.
Reference
Optical Microscope Analysis
- Standard visual observation: Sample observed to be a very fine powder
- Observation at 100 x magnification: The particles appeared to be irregular shapes. The smallest individual particle size was approximately 6 μm and the largest individual size was approximately 10 μm.
- Observation at 400 x magnification: The sample was observed to be made up of agglomerated small particles.
Laser diffraction particle size analysis
- Full Test Results (in μm):
RUN 1 |
RUN 2 |
RUN 3 |
RUN 4 |
RUN 5 |
*Average |
|
Volume weighted Mean |
6.339 |
6.389 |
6.303 |
6.274 |
6.215 |
6.304 |
Median (d.50) |
5.855 |
5.896 |
5.802 |
5.785 |
5.722 |
5.812 |
Mode (μm) |
6.537 |
6.595 |
6.492 |
6.479 |
6.417 |
6.505 |
MMAD |
11.899 |
11.982 |
11.792 |
11.756 |
11.629 |
11.811 |
10 % of material is < |
2.150 |
2.151 |
2.097 |
2.080 |
2.051 |
2.105 |
50 % of material is < |
5.855 |
5.896 |
5.802 |
5.785 |
5.722 |
5.812 |
90 % of material is < |
11.300 |
11.413 |
11.299 |
11.227 |
11.148 |
11.278 |
*Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.
Description of key information
The MMAD was 11.811 μm.
The median D50 was 5.812 µm; 90% of all particles were < 11.278 µm and 84.51% by volume of sample was seen to be < 10.00 μm.
Additional information
According to ISO 13320:2009, CIPAC MT 187 and GLP principles the particle size distribution of the substance was determined using laser diffraction analysis (dry powder module).
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