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 10 March 2016 to 16 March 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
Cross-reference
Reason / purpose:
reference to other study
Reference
Endpoint:
relative density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 01 February 2016 to 20 April 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method A.3 (Relative Density)
Version / remarks:
2008
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:
Test substance was dried in a desiccator under vacuum using silicagel as the drying agent at 20.0 ± 0.2°C in the dark for 42 hours.
Key result
Type:
relative density
Density:
1.69 other: no dimension
Temp.:
20 °C
Type:
density
Density:
1.69 g/cm³
Temp.:
20 °C

Experiment 1: 1.684

Experiment 2: 1.694

The key value is the mean of both values. The accuracy is < 0.02 g/cm3.

Conclusions:
The relative density at 20°C of the substance Broomdex was determined to be 1.69.
Executive summary:

The relative density was determined using a gas comparison pycnometer in a GLP study according to EC A.3, OECD 109 and OPPTS 830.7300. The relative density was determined in duplicate at 20°C obtaining a mean value of 1.69.

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: particulate/powder
Details on test material:
- Appearance: off-white powder
- Storage condition of test material: At room temperature
Specific details on test material used for the study:
Relative density: 1.69

Results and discussion

Mass median aerodynamic diameter:
36.717 µm
Geometric standard deviation:
>= 4.174 - <= 4.333
Remarks on result:
other: The MMAD is the mean of 5 measurements.
Particle sizeopen allclose all
Key result
Percentile:
D10
Mean:
3.931 µm
St. dev.:
0.032
Remarks on result:
other: St.dev.= population standard deviation [µm]
Key result
Percentile:
D50
Mean:
28.244 µm
St. dev.:
0.204
Key result
Percentile:
D90
Mean:
86.973 µm
St. dev.:
1.502
Key result
Percentile:
other: D22.25
Mean:
< 10 µm
Remarks on result:
other: St.dev.: no data

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 Broomdex: D10= 3.9 µm, D50= 28.2 µm and D90=87 µm. 22.3% is < 10 µm. MMAD = 36.7 µm.

Executive summary:

Under a microscope, the substance was observed to be made up of single crystalline particles. The particle size distribution 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. 22.3% of test material was determined to be smaller than 10 µm, 10% is smaller than 3.9 µm (D10), 50% is smaller than 28.2 µm (D50) and 90% is smaller than 87 µm (D90). The MMAD was determined to be 36.7 µm.