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Diss Factsheets

Physical & Chemical properties

Particle size distribution (Granulometry)

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015
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’, 2002.
Deviations:
no
GLP compliance:
yes
Type of method:
sieving
Type of distribution:
volumetric distribution
Remarks on result:
not measured/tested
Percentile:
D50
Remarks on result:
not measured/tested
No.:
#1
Size:
< 100 µm
Distribution:
6.83 %
Remarks on result:
other:
Remarks:
percentage of material passing a 100 µm sieve was calulated based masses

Sieve Screening Test

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

 

Measurement

Result

Mass of test item transferred to sieve

13.04 g

Mass of test item passed through sieve

0.89 g

Percentage of test item less than 100 µm

6.83 %

Conclusions:
The percentage of FAT 36152/N having an inhalable particle size of less than 100 µm was determined to be 6.83 %. The test item has been considered to be essentially non-inhalable.
Executive summary:

The proportion of FAT 36152/N having an inhalable particle size of less than 100 µm was determined by a sieve method to be 6.83 %, using a procedure designed to be compatible with the European Commission Technical Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances’ (2002). The test item has been considered to be essentially non-inhalable.

Description of key information

The percentage of FAT 36152/N having an inhalable particle size of less than 100 µm was determined to be 6.83 %. The test item has been considered to be essentially non-inhalable.

Additional information

A study was performed to determine the particle size of FAT 36152/N using a procedure designed to be compatible with the European Commission Technical Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances (2002). The proportion of FAT 36152/N having an inhalable particle size of less than 100 µm was determined by a sieve method to be 6.83 %. The test item has been considered to be essentially non-inhalable.