Rye, ext.

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Deviations:

no

GLP compliance:

no

Type of method:

Laser scattering/diffraction

Type of particle tested:

agglomerate

Type of distribution:

volumetric distribution

Test material

Test material information

Constituent 1

Reference substance name:

Rye, ext.

EC Number:

290-271-3

EC Name:

Rye, ext.

Cas Number:

90106-48-2

IUPAC Name:

Oligosaccharides and polysaccharides of glucose from Rye

Test material form:

solid: particulate/powder

Details on test material:

- Appearance: white powder
- Storage In darkness at room temperature
- Batch: 16 167
- Manufacturing date: June 2016
- Expiry date: June 2018

Specific details on test material used for the study:

Particle size: non spherical
Particle size refractive index: 1.538 (sugars)
Particle size absorption index: 0.010 (sugars)
Approximate density of the powder: 1 g/cm3

Results and discussion

Particle size

Particle size 1

Key result

Percentile:

D50

Mean:

ca. 85.1 µm

St. dev.:

0.33

Particle size 2

Key result

Percentile:

D10

Mean:

ca. 44 µm

St. dev.:

2.86

Particle size 3

Key result

Percentile:

D90

Mean:

ca. 152 µm

St. dev.:

0.71

Any other information on results incl. tables

9 measurements were made during the passage of the powder in the apparatus, the particle size distribution of COHELISS^®AT is a Gaussian distribution between 11 µm and 120 µm with a peak at 89.4 µm and additionally a small fraction of fine particle down to 6 µm.

D₅₀was averaged on the 9 measures with a Relative Standard Deviation (RSD) of 0.28%: D₅₀= 85.1 µm.

As the relative standard deviation is below 3%, the measurement is considered to comply with the International Standard.

The additional following data were determined:

·        D₁₀= 44 µm (the diameter at which 10% of the sample's mass is comprised of particles with a diameter less than this value)

·        D₉₀= 152 (the diameter at which 90% of the sample's mass is comprised of particles with a diameter less than this value)

·        Particle < 4 µm : 0%

·        Particle < 10 µm : 0.8%

·        Particle < 100 µm : 72%

·        Particle < 500 µm : 100%

Applicant's summary and conclusion

Conclusions:

The particle size distribution of the test substance was determined by laser diffraction according to ISO 13320-2009.
The test item has a median particle size D50 = 85.1 μm.

Executive summary:

The particle size distribution of the test substance was determined by laser diffraction according to ISO13320-2009 in an appropriate dispersive solvent (ethanol).

The MIE diffusion model was used to obtain the volumetric distribution of the test substance.

9 measurements were made during the passage of the powder in the apparatus, the following parameters were determined:

·        D₁₀= 44 µm

·        D₉₀= 152 µm

·        Particle < 4 µm : 0%

·        Particle < 10 µm : 0.8%

·        Particle < 100 µm : 72%

·        Particle < 500 µm : 100%