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Diss Factsheets

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 17 March 2017 to 21 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
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187 (Particle size analysis by laser diffraction)
Version / remarks:
version not specified in the study report
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.
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution

Test material

1
Reference substance name:
Reaction products of Resin acids and Rosin acids, sodium salts and barium chloride
Molecular formula:
not applicable
IUPAC Name:
Reaction products of Resin acids and Rosin acids, sodium salts and barium chloride
Test material form:
solid: particulate/powder
Details on test material:
- Appearance: Light tan powder
- Storage conditions: At room temperature
Specific details on test material used for the study:
Relative density: 1.23

Results and discussion

Mass median aerodynamic diameter:
8.597 µm
Geometric standard deviation:
>= 2.96 - <= 3.034
Remarks on result:
other: MMAD is the mean (n= 5) value. 'St.dev.' in table below is the population standard deviation [µm].
Particle sizeopen allclose all
Key result
Percentile:
D10
Mean:
2.023 µm
St. dev.:
0.006
Key result
Percentile:
D50
Mean:
7.752 µm
St. dev.:
0.099
Key result
Percentile:
D90
Mean:
136.176 µm
St. dev.:
3.339
Particle size distribution at different passages
No.:
#1
Size:
< 10 µm
Distribution:
55.99 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.

VISUAL OBSERVATION

The substance was observed to be a fine to medium light tan powder with some clusters. At 32x magnification under a microscope, the particles appeared to be irregular shaped crystals. The smallest individual particle size was

approximately 3 μm and the largest individual size was approximately 176 μm. At 400x magnification, the sample was observed to be made up of single crystalline particles.

Applicant's summary and conclusion

Conclusions:
Particle size distribution of the substance: D10= 2.023 µm, D50= 7.752 µm and D90= 136.176 µm. 56% by volume was determined to be smaller than 10 µm. The MMAD was determined to be 8.597 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.

D10= 2.023 µm, D50= 7.752 µm and D90= 136.176 µm. 56% by volume was determined to be smaller than 10 µm. The MMAD was determined to be 8.597 µm.