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Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 December 1999
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:
no guideline followed
Principles of method if other than guideline:
Laser diffraction analysis was performed. 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 kinds.

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: 1.32
Test material as received at the test facility was used for particle size testing.
Remarks on result:
other: no MMAD and geomteric standard deviation in the study report
Key result
Percentile:
D10
Mean:
23.94 µm
St. dev.:
0.91
Remarks on result:
other: mean of 3 runs
Key result
Percentile:
D25
Mean:
84.1 µm
St. dev.:
5.4
Remarks on result:
other: mean of 3 runs
Key result
Percentile:
D50
Mean:
266.8 µm
St. dev.:
12.9
Remarks on result:
other: mean of 3 runs
Key result
Percentile:
D75
Mean:
517.2 µm
St. dev.:
11.4
Remarks on result:
other: mean of 3 runs
Key result
Percentile:
D90
Mean:
714.4 µm
St. dev.:
5.5
Remarks on result:
other: mean of 3 runs

Mean: 176.7 µm

Median: 266.8 µm

Mode: 654.3 µm

Conclusions:
Particle size (volumetric) distribution by laser diffraction analysis: D10= 23.94 µm, D25= 84.10 µm, D50=266.8 µm, D75= 517.2 µm and D90= 714.4 µm. Mean: 176.7 µm. MMAD: 306.5 µm.


Executive summary:

The particle size distribution of the substance was determined using laser diffraction analysis (dry powder module) in a GLP study. Each result is the average of three runs. Particle size distribution (volumetric): D10= 23.94 µm, D25= 84.10 µm, D50=266.8 µm, D75= 517.2 µm and D90= 714.4 µm. MMAD: 306.5 µm.

Description of key information

Particle size (volumetric) distribution by laser diffraction analysis: D10= 23.94 µm, D25= 84.10 µm, D50=266.8 µm, D75= 517.2 µm and D90= 714.4 µm.

Additional information

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