(R)-2-(2,4-Difluorphenyl)-1,1-difluor-3-(tetrazol-1-yl)-1-{5-[4-(2,2,2-trifluorethoxy)-phenyl]-2-pyridyl}-2-propanol-(R,R)-tartrate

Particle size distribution (Granulometry)

Link to relevant study record(s)

Reference

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2020-03-18 to 2020-03-26

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)

Qualifier:

equivalent or similar to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Qualifier:

equivalent or similar to guideline

Guideline:

other: CIPAC MT 187: Particle Size Analysis by Laser Diffraction

Qualifier:

equivalent or similar to guideline

Guideline:

other: Guidance on information requirements and chemical safety assessment, Chapter R.7a: Endpoint specific guidance, version 6.0, July 2017, European Chemicals Agency

GLP compliance:

no

Type of method:

Laser scattering/diffraction

Type of particle tested:

primary particle

Type of distribution:

volumetric distribution

Mass median aerodynamic diameter:

8.1 µm

Key result

Percentile:

D50

Mean:

8.1 µm

Remarks on result:

other: Standard deviation not reported

Key result

Percentile:

D10

Mean:

2.8 µm

Remarks on result:

other: Standard deviation not reported

Key result

Percentile:

D90

Mean:

93.2 µm

Remarks on result:

other: Standard deviation not reported

The test item consisted of opaque irregular shaped particles which appeared partially agglomerated. Thus, the test item was tested as a liquid dispersion in silicon oil

The median particle size L50 (D (v, 0.5): 50 % of particle volume with lower particle diameter) deduced from these distributions were:

1st test series: L50 = 8.2 µm

2nd test series: L50 = 7.9 µm

The average of the median particle size L50 was:

L50 = 8.1 µm

The particle size L10 (D (v, 0.1): 10 % of particle volume with lower particle diameter) deduced from these distributions were:

1st test series: L10 = 2.8 µm

2nd test series: L10 = 2.8 µm

The average of the particle size L10 was:

L10 = 2.8 µm

The particle size L90 (D (v, 0.9): 90 % of particle volume with lower particle diameter) deduced from these distributions were:

1st test series: L90 = 94.2 µm

2nd test series: L90 = 92.2 µm

The average of the particle size L90 was:

L90 = 93.2 µm

Two maxima were observed at approximately 5 µm and 90 µm.

Conclusions:

The average of the median particle size L50 was:
L50 = 8.1µm
The average of the particle size L10 was:
L10 = 2.8 µm
The average of the particle size L90 was:
L90 = 93.2 µm

Executive summary:

The particle size distribution of the test item was determined by laser diffraction (light scattering). The test item consisted of opaque irregular shaped particles which appeared partially agglomerated. Thus, the test item was tested as a liquid dispersion in silicon oil.

The median particle size L50 of the test item deduced from the particle size distributions was: 8.1 µm

The median particle size L10 of the test item deduced from the particle size distributions was: 2.8 µm

The median particle size L90 of the test item deduced from the particle size distributions was: 93.1 µm

Description of key information

The particle size distribution of the test item was determined by laser diffraction (light scattering). The test item consisted of opaque irregular shaped particles which appeared partially agglomerated. Thus, the test item was tested as a liquid dispersion in silicon oil.

The median particle size L50 of the test item deduced from the particle size distributions was: 8.1 µm

The median particle size L10 of the test item deduced from the particle size distributions was: 2.8 µm

The median particle size L90 of the test item deduced from the particle size distributions was: 93.1 µm