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Physical & Chemical properties

Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14/11/2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
other: European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002)
GLP compliance:
yes (incl. QA statement)
Other quality assurance:
other: ISO 3310-1: 2000
Type of method:
sieving
Remarks:
100 µm stainless steel mesh (ISO 3310-1: 2000)
Type of particle tested:
other:
Type of distribution:
mass based distribution
Specific details on test material used for the study:
Batch/Lot: 0007956847
Key result
Remarks on result:
other: 0.73% has a size of < 100 µm.
No.:
#1
Size:
< 100 µm
Distribution:
0.73 %

Table 4 Results of the sieving procedure are shown in the following table:

Measurement

Result

Mass of test item transferred to sieve (W1)

12.34 g

Mass of test item passed through sieve (W3– W2)

0.09 g

Percentage of test item less than 100 µm

0.73 %
Conclusions:
The percentage of Ethyl Maltol having an inhalable particle size of less than 100 µm was determined to be 0.73%. The test item has been considered to be essentially non-inhalable.
Executive summary:

The percentage of Ethyl Maltol having an inhalable particle size of less than 100 µm was determined to be 0.73% according to a procedure designed to be compatible with European Commission 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 Ethyl Maltol having an inhalable particle size of less than 100 µm was determined to be 0.73% according to a proceduredesigned to be compatible with European Commission 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.

Additional information