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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:
03/01/2019 - 14/02/2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Cross-reference
Reason / purpose:
reference to other study
Reference
Endpoint:
relative density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07 Jan 2019 - 14 Feb 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method A.3 (Relative Density)
Version / remarks:
2016
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 109 (Density of Liquids and Solids)
Version / remarks:
2012
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7300 (Density / Relative Density / Bulk Density)
Version / remarks:
2002
Deviations:
no
GLP compliance:
yes
Type of method:
air comparison pycnometer (for solids)
Specific details on test material used for the study:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test item was dried for 44 hours in a desiccator under vacuum using silica gel as the drying agent at 18.7 ± 0.1°C and protected from light.
Key result
Type:
relative density
Density:
1.1 other: dimensionless
Temp.:
20 °C
Remarks on result:
other: D 20 /4
Key result
Type:
density
Density:
1.1 g/cm³
Temp.:
20 °C

Relative density:

Experiment 1: 1.102

Experiment 2: 1.104

Mean: 1.10

Conclusions:
The relative density D20/4 of the substance was determined to be 1.10.
Executive summary:

The relative density of the substance was determined in a GLP study according to EC A.3, OECD 109 and OPPTS 830.7300 (method: air comparison pycnometer (for solids)).

A gas comparison pycnometer was used with Helium as the gas. The relative density D20/4 was determined in duplicate obtaining a mean value of 1.10.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2019

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)
Version / remarks:
Handbook K, 2007
Principles of method if other than guideline:
According to REACH 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 regulation (EC) No 440/2008. OECD 110 TG ‘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 Guidance on information requirements and Chemical Safety Assessment-Chapter R.7a stipulates that many methods are available for particle size measurements but none of them is applicable to the entire size range. The guidance mentions Laser scattering/diffraction as a method for particles of all kind and makes reference to ISO 13320:2009.

According to Guidance document EUR 20268 (2002), the laser diffraction technique is applicable to particles of respirable and inhalable size. The MMAD can be calculated when density is known.
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: particulate/powder
Details on test material:
- Appearance: Off-white powder
- Storage condition of test material: In refrigerator protected from light
Specific details on test material used for the study:
Relative density: 1.10 (see Cross-reference)

Results and discussion

Mass median aerodynamic diameter:
24.1 µm
Geometric standard deviation:
>= 2.524 - <= 2.565
Remarks on result:
other: MMAD and GSD above are both the average of 5 runs. GSD was calculated from d50/d15.78. The St.dev. in the table below is the population standard deviation [µm].
Particle sizeopen allclose all
Key result
Percentile:
D10
Mean:
7.92 µm
St. dev.:
0.049
Key result
Percentile:
D50
Mean:
23 µm
St. dev.:
0.136
Key result
Percentile:
D90
Mean:
87.7 µm
St. dev.:
1.12
Particle size distribution at different passages
No.:
#1
Size:
< 10 µm
Distribution:
16 other: vol%

Any other information on results incl. tables

Coefficient of variation for D50 is < 3%; D10 and D90 are < 5%. These values are within the acceptable limits mentioned in the ISO 13320 standard.

Applicant's summary and conclusion

Conclusions:
Particle size distribution of the substance: D10= 7.92 µm, D50= 23.0 µm and D90= 87.7 µm. 16% by volume was determined to be smaller than 10 µm. The MMAD was calculated to be 24.1 µm.
Executive summary:

Laser diffraction analysis (dry powder module) was performed in a GLP study according to ISO 13320 and CIPAC MT 187. The sample was tested as such. Each result is the average of five runs. Particle size distribution of the substance: D10= 7.92 µm, D50= 23.0 µm and D90= 87.7 µm. 16% by volume was determined to be smaller than 10 µm. The MMAD was calculated to be 24.1 µm.