Registration Dossier

Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 March 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
Qualifier:
according to
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. certificate)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Type:
impurity
Type:
impurity
Test material form:
solid: crystalline
Details on test material:
Appearance: white crystalline powder
Storage conditions: at room temperature protected from light
Specific details on test material used for the study:
Relative density: 1.37

Results and discussion

Mass median aerodynamic diameter:
209.2 µm
Geometric standard deviation:
>= 1.976 - <= 1.996
Remarks on result:
other: Mass median aerodynamic diameter (MMAD) is the mean of 5 measurements.
Particle sizeopen allclose all
Key result
Percentile:
D10
Mean:
69.455 µm
St. dev.:
0.827
Remarks on result:
other: St.dev.= population standard deviation [µm]
Key result
Percentile:
D50
Mean:
178.752 µm
St. dev.:
1.12
Key result
Percentile:
D90
Mean:
352.477 µm
St. dev.:
2.368
Particle size distribution at different passages
No.:
#1
Size:
< 10 µm
Distribution:
0.61 other: % by volume

Any other information on results incl. tables

Coefficient of variation for D50 is < 3% and for D10 and D90 < 5%; repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320 standard.

Applicant's summary and conclusion

Conclusions:
Particle size distribution of the substance: D10= 69.455 µm, D50= 178.752 µm and D90= 352.477 µm. 0.61% by volume is smaller than 10 µm. MMAD= 209.2 µm.

Executive summary:

The particle size distribution of the substance was determined using laser diffraction analysis (dry powder module) in a GLP study according to ISO 13320 and CIPAC MT 187. Each result is the average of five runs. Particle size distribution of the substance: D10= 69.455 µm, D50= 178.752 µm and D90= 352.477 µm. 0.61% by volume is smaller than 10 µm. MMAD= 209.2 µm.