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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:

2019-11-11 to 2020-01-23

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions) - Method B: Fibre Length and Diameter Distributions

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187: Particle Size Analysis - Laser Diffraction Methods

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of particle tested:

primary particle

Type of distribution:

volumetric distribution

Specific details on test material used for the study:

- Batch No.: 2019002
- Purity: 98.39 %
- Physical state: White solid
- Storage conditions: Ambient temperature (10–30 °C)
- Expiry date: 2020-10-21

Mass median aerodynamic diameter:

>= 131 - <= 336 µm

Key result

Percentile:

D50

Mean:

>= 131 - <= 336 µm

Remarks on result:

other: three test series

Key result

Percentile:

D10

Mean:

>= 30 - <= 62 µm

Remarks on result:

other: three test series

Key result

Percentile:

D90

Mean:

>= 436 - <= 981 µm

Remarks on result:

other: three test series

The particle size distribution showed considerably lower particle sizes in the first than in the second test series.

lt could not be excluded that the preparation of the first test series deviated from the second test series (e.g. longer preparation time). Therefore, a third test series was performed similar to the second test series. This showed comparable values both to the second test series as well as the microscopic image. ln order to further analyze this, the three measurements of each test series were evaluated. These measurements within a test series showed no temporal course.

However, the single measurements showed nevertheless significant deviations within a test series. Due to the results, it was concluded that the particle sizes within the test item were inhomogeneous (Due to the differences from the first test series to the second and third it cannot be completely excluded that the test item showed a minor solubility leading to smaller particle sizes in test series 1).

The inhomogeneous effect could have been amplified due to the small sample amount used in these tests (Due to the limited amount of sample available a dry dispersion could not be performed.)

As a consequence, the particle sizes of all three test-series will be given as range.

The particle size distributions determined in the test series are shown in the table below. Representative figures of the temporal courses (presented in percent by volume as a function of the particle size) of all three test-series are provided within the original report. Median values were calculated from unrounded values.

 

	L10^*	L50^**	L90^***
1^sttest series	30.8 µm	151.5 µm	436.4 µm
2^ndtest series	61.7 µm	386.0 µm	915.8 µm
3^rdtest series	53.7 µm	332.3 µm	980.3 µm
Range	30 – 62 µm	131 – 386 µm	436 – 981 µm

^*: 10 % of particle volume or particle mass with lower particle Diameter

^**: median particle size: 50 % of particle volume or particle mass with lower particle Diameter

^***: 90 % of particle volume or particle mass with lower particle Diameter

 

Conclusions:

The range of particle sizes of the test item deduced from the particle size distributions was:
L50: 131 to 386 µm
L10: 30 to 62 µm
L90: 436 to 981 µm

Executive summary:

In a GLP study conducted according to OECD TG 110, the particle size distriution was determined using the laser diffraction technique.

The particle size distribution was measured as dispersion in n-hexane in three test series.

The range of particle sizes of the test item deduced from the particle size distributions was
L₅₀: 131 to 386 µm

L₁₀: 30 to 62 µm

L₉₀: 436 to 981 µm

Description of key information

In a GLP study conducted according to OECD TG 110, the particle size distriution was determined using the laser diffraction technique.

The particle size distribution was measured as dispersion in n-hexane in three test series. The range of particle sizes of the test item deduced from the particle size distributions was:

L₅₀: 131 to 386 µm

L₁₀: 30 to 62 µm

L₉₀: 436 to 981 µm