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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:
23 April 2012 - 29 June 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
other: ‘Particle Size Distribution, Fibre Length and Diameter Distribution', June 1996 European Commission technical guidance document
GLP compliance:
yes (incl. QA statement)
Type of method:
sieving
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution
No.:
#1
Size:
< 100 µm
Distribution:
2.9 %
No.:
#1
Size:
> 100 µm
Distribution:
98.1 %

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

Measurement

Result

Mass of test item transferred to sieve

12.68 g

Mass of test item passed through sieve

0.37 g

Proportion of test item <100 µm

2.9 %

 

Conclusions:
The proportion of test item having an inhalable particle size of less than 100 µm was determined to be 2.9 %. Therefore, the test item was considered to be essentially non-inhalable.
Executive summary:

The particle size distribution of the test material was evaluated in accordance with OECD Guideline 110 under GLP conditions.

The proportion of a sample that was able to pass through a 100 µm sieve was measured; the proportion of test item having an inhalable particle size of less than 100 µm was determined to be 2.9 %.

Therefore, the test item was considered to be essentially non-inhalable.

Description of key information

The proportion of a sample that was able to pass through a 100 µm sieve was measured; the proportion of test material having an inhalable particle size of less than 100 µm was determined to be 2.9 %.

Therefore, the test material was considered to be essentially non-inhalable.

Additional information

The particle size distribution of the test material was evaluated in accordance with OECD Guideline 110 under GLP conditions. It was assigned a reliability score of 1 in accordance with the principles for assessing data quality as outlined by Klimisch et al (1997).

The proportion of a sample that was able to pass through a 100 µm sieve was measured; the proportion of test material having an inhalable particle size of less than 100 µm was determined to be 2.9 %.

Therefore, the test material was considered to be essentially non-inhalable.