Soybean meal, protein extn. residue

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:

04 January 2018 to 30 March 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: European Commission Guidance Document EUR 20268 'Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances'.

Version / remarks:

2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

sieving

No.:

#1

Size:

< 100 µm

Distribution:

5 %

Table 1: Results of the Sieving Procedure

Measurement	Result
Mass of test material transferred to sieve (W1)	14.32 g
Mass of test material passed through sieve (W3– W2)	0.72 g
Percentage of test material less than 100 µm	5.0 %

Discussion

The inhalable fraction is defined as the mass fraction of particles which can be inhaled by nose or mouth, the thoracic fraction is defined as the mass fraction of particles that passes the larynx and the respirable fraction is defined as the mass fraction of particles that reaches the alveoli.

Conclusions:

Under the conditions of this study, the percentage of test material having an inhalable particle size of less than 100 μm was determined to be 5.0 %. The test material has been considered to be essentially non-inhalable.

Executive summary:

The particle size distribution of the test material was investigated in accordance with the European Commission Guidance Document EUR 20268 'Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances', the testing was performed under GLP conditions.

An aliquot of the test material was added to a 100 μm sieve and was placed on a sieve shaker for a period of approximately 30 minutes. The sieve shaker table had an inclination of 4.5 °, a nominal rotation speed of 2.5 rpm and vibrated at approximately 300 oscillations/min with an approximately 4 mm amplitude. Following the shaking period, the mass of the receiver pan and collected test material was recorded and the percentage of test material with a particle size less than 100 μm calculated.

Under the conditions of this study, the percentage of test material having an inhalable particle size of less than 100 μm was determined to be 5.0 %. The test material has been considered to be essentially non-inhalable.

Description of key information

Under the conditions of this study, the percentage of test material having an inhalable particle size of less than 100 μm was determined to be 5.0 %. The test material has been considered to be essentially non-inhalable.

Additional information

The particle size distribution of the test material was investigated in accordance with the European Commission Guidance Document EUR 20268 'Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances', the testing was performed under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

An aliquot of the test material was added to a 100 μm sieve and was placed on a sieve shaker for a period of approximately 30 minutes. The sieve shaker table, had an inclination of 4.5 °, a nominal rotation speed of 2.5 rpm and vibrated at approximately 300 oscillations/min with an approximately 4 mm amplitude. Following the shaking period, the mass of the receiver pan and collected test material was recorded and the percentage of test material with a particle size less than 100 μm calculated.

Under the conditions of this study, the percentage of test material having an inhalable particle size of less than 100 μm was determined to be 5.0 %. The test material has been considered to be essentially non-inhalable.