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Physical & Chemical properties

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 2014-19 December 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant study in accordance with ISO 13320 and CIPAC MT 187.
Qualifier:
according to guideline
Guideline:
other: ISO 13320:2009
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187
Deviations:
no
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 distribution:
volumetric distribution
Mass median aerodynamic diameter:
>= 33.64 - <= 34.88 µm
Geometric standard deviation:
>= 2.17 - <= 2.18
Key result
Percentile:
D10
Mean:
9.878 µm
St. dev.:
0.091
Remarks on result:
other: St.dev. = population standard deviation [µm]
Percentile:
D50
Mean:
28.525 µm
St. dev.:
0.329
Percentile:
D90
Mean:
60.043 µm
St. dev.:
0.913
No.:
#1
Size:
< 10 µm
Distribution:
10.19 %

Mean (n=5) MMAD: 34.23 µm (population standard deviation: 0.40 µm)

Mode: 32.89 µm

 

The coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320 standard.

Conclusions:
In a GLP-compliant study in accordance with ISO 13320 and CIPAC MT 187 using laser diffraction analysis (dry powder module), the particle size distribution of the substance was determined: 10% < 9.88 µm; 10.19% < 10.00 µm; 50% < 28.53 µm; 90% < 60.04 µm. MMAD is 34.23 µm.

Description of key information

In a GLP-compliant study in accordance with ISO 13320 and CIPAC MT 187 using  laser diffraction analysis (dry powder module),  the particle size distribution of the substance was determined: 10% < 9.88 µm; 10.19% < 10.00 µm; 50% < 28.53 µm; 90% < 60.04 µm.  MMAD is 34.23 µm.

Additional information