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:
From 06 June 2016 to 15 August 2016
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:
2016
Report Date:
2016

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
Test material form:
solid
Details on test material:
- Appearance: white solid
- Storage conditions: in refrigerator (2-8°C) protected from light
Specific details on test material used for the study:
Relative density: 1.54

Results and discussion

Mass median aerodynamic diameter:
100.971 µm
Geometric standard deviation:
>= 1.583 - <= 1.589
Remarks on result:
other: Mass median aerodynamic diameter (MMAD) is the mean of 5 measurements.
Particle sizeopen allclose all
Key result
Percentile:
D10
Mean:
45.499 µm
St. dev.:
0.2
Remarks on result:
other: St.dev.= population standard deviation [µm]
Key result
Percentile:
D50
Mean:
81.365 µm
St. dev.:
0.38
Remarks on result:
other: St.dev.= population standard deviation [µm]
Key result
Percentile:
D90
Mean:
141.74 µm
St. dev.:
0.826
Remarks on result:
other: St.dev.= population standard deviation [µm]
Particle size distribution at different passages
No.:
#1
Size:
< 10 µm
Distribution:
0
Remarks on result:
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: D10= 45 µm, D50= 81 µm and D90= 142 µm. 0% is smaller than 10 µm. MMAD= 101 µm.



Executive summary:

The substance was visually observed to be a white solid powder. Under a microscope, the substance was observed to be made up of single crystalline particles. The particle size distribution of the substance was determined using laser diffraction analysis (small volume wet module) in a GLP study according to ISO 13320 and CIPAC MT 187. Each result is the average of five runs. D10= 45 µm, D50= 81 µm and D90= 142 µm. 0% is smaller than 10 µm. MMAD= 101 µm.