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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:
Experimental Starting Date: 17 May 2012, Experimental Completion Date: 03 July 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Qualifier:
according to guideline
Guideline:
other: The method used is based on a procedure designed to be compatible with European Commission Technical Guidance Document 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 distribution:
mass based distribution
Percentile:
D50
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
No.:
#1
Size:
< 100 µm
Distribution:
0.165 %

   

Results

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

 

Table 3.33

 

Measurement

Result

Mass of test item transferred to sieve

12.09 g

Mass of test item passed through sieve

0.02 g

Proportion of test item <100 µm

0.165 %

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.

 

The cascade impactor method was not performed as it was considered that too small an amount of test item passed through the 100 µm sieve.

Conclusions:
The proportion of test item having an inhalable particle size of less than 100 µm was determined to be 0.165 %. The test item has been considered to be essentially non-inhalable.
Executive summary:

Method

The method used is based on a procedure designed to be compatible with European Commission Technical Guidance Document EUR 20268 Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances (2002).

       

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.

Conclusion

The proportion of test item having an inhalable particle size of less than 100 µm was determined to be 0.165 %. The test item has been considered to be essentially non-inhalable.

Description of key information

The proportion of test item having an inhalable particle size of less than 100 µm was determined to be 0.165 %.  The test item has been considered to be essentially non-inhalable.

Additional information

Particle Size Distribution

The method used is based on a procedure designed to be compatible with European Commission Technical Guidance Document EUR 20268 Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances (2002).

 

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

 

Measurement

Result

Mass of test item transferred to sieve

12.09 g

Mass of test item passed through sieve

0.02 g

Proportion of test item <100 µm

0.165 %

The inhalable fraction is defined as the mass fraction of particles which can be inhaled by nose or mouth (nominal cut off value used 100 µm) the thoracic fraction is defined as the mass fraction of particles that passes the larynx (nominal cut off value used <10.0 µm) and the respirable fraction is defined as the mass fraction of particles that reaches the alveoli (nominal cut off value used <5.5 µm).

The proportion of test item having an inhalable particle size of less than 100 µm was determined to be 0.165 %. The test item has been considered to be essentially non-inhalable.