N,N'-(2-(4-(2-aminobenzamido)butyl)pentane-1,5-diyl)bis(2-aminobenzamide)

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:

Experimental Phase: 14 June 2020 to 05 September 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: EUR 20268 'Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances' (2002)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

sieving

Type of particle tested:

primary particle

Key result

Percentile:

other: Percentage of test item less than 100 µm

Mean:

ca. 1.07 other: %

St. dev.:

0

The results of the sieving procedure are shown in the following table:

Measurement	Result
Mass of test item transferred to sieve (W1)	15.00g
Mass of test item passed through sieve (W3 – W2)	0.16g
Percentage of test item less than 100 µm	1.07%

Conclusions:

The percentage of test item having an inhalable particle size of less than 100 µm was determined to be 1.07%. The test item was therefore considered to be essentially noninhalable.

Executive summary:

Introduction

 

The particle size of the test item was determined using a method designed to meet the requirements of the following guideline:

• European Commission Guidance Document EUR 20268 'Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances' (2002).  

Method

Sieving Apparatus

Instrument: Inclyno Sieve Shaker, Model No 1  

Sieve: 100 μm stainless steel mesh (ISO 3310-1: 2000)

Sieve Screening Test

An aliquot (15.00 g) of test item was added to a 100 µm sieve fitted onto a receiver pan of known mass. A lid was then secured onto the sieve and the assembled apparatus placed on a sieve shaker for a period of approximately 30 minutes. The sieve shaker table, on which the sieve rests, 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 item was recorded and the percentage of test item with a particle size less than 100 µm calculated.

Results

The results of the sieving procedure are shown in the following table:

Measurement	Result
Mass of test item transferred to sieve (W1)	15.00g
Mass of test item passed through sieve (W3– W2)	0.16g
Percentage of test item less than 100 µm	1.07%

 

Conclusion

The percentage of test item having an inhalable particle size of less than 100 µm was determined to be 1.07%. The test item was therefore considered to be essentially noninhalable.

 

Description of key information

Particle size data summary.

Additional information

The percentage of test item having an inhalable particle size of less than 100 µm was determined to be 1.07%. The test item was therefore considered to be essentially noninhalable.