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Diss Factsheets

Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 21 January 2016 to 17 February 2016.
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 Type:
study report
Report date:

Materials and methods

Test guidelineopen allclose all
according to guideline
other: ISO 13320:2009
according to guideline
other: CIPAC MT 187
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.

The analysis is conducted initially with a visual examination using a microscope and is then undertaken more formally using a Laser Diffraction Particle Size Analyser.
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

Constituent 1
Chemical structure
Reference substance name:
N,N,N-tributylbutan-1-aminium ({[(2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]oct-6-yl]oxy}sulfonyl)oxidanide
EC Number:
Cas Number:
Molecular formula:
C23 H46 N4 O6 S
N,N,N-tributylbutan-1-aminium ({[(2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]oct-6-yl]oxy}sulfonyl)oxidanide
Test material form:
Details on test material:
- Name of test material (as cited in study report): SAM-3
- Lot/batch No.: SAM-3/660-137/K1
- Material number: P60689-51
- Storage conditions: ambient temperature, dry, well ventilated area protected from sunlight.
Specific details on test material used for the study:
- Relative density at 20°C: 1.12 (see endpoint 4.4)
- Tested as received

Results and discussion

Mass median aerodynamic diameter:
166.763 µm
Geometric standard deviation:
>= 4.883 - <= 5.068
Particle sizeopen allclose all
Key result
17.305 µm
St. dev.:
Remarks on result:
other: population standard deviation [µm]
Key result
157.576 µm
St. dev.:
Remarks on result:
other: population standard deviation [µm]
Key result
427.977 µm
St. dev.:
Remarks on result:
other: population standard deviation [µm]

Any other information on results incl. tables

-6.03% by volume was seen to be < 10.00 µm.

-Population standard dev. (MMAD)= 2.43 µm

Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. Thus 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

In a GLP-compliant study in accordance with ISO 13320 and CIPAC MT 187 using laser diffraction analysis (dry powder module), the particle size distribution of the substance was determined: 6.0% < 10.00 µm, 10% < 17.3 µm, 50% < 158 µm and 90% < 428 µm. MMAD= 167 µm.