Neodymium(3+) acetate

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:

30 June 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: European Commission Technical Guidance Document EUR 20268 'Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’

Version / remarks:

2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

sieving

Type of particle tested:

primary particle

Type of distribution:

mass based distribution

Key result

Remarks on result:

other: The percentage of test material having an inhalable particle size of less than 100 μm was determined to be 7.8 %.

Table 1: Table to show the results of the sieving procedure

Measurement	Result
Mass of test material transferred to sieve (W1)	14.25 g
Mass of test material passed through sieve (W3 – W2)	1.11 g
Percentage of test material less than 100 μm	7.79 %

Conclusions:

Under the conditions of the study the percentage of test material having an inhalable particle size of less than 100 μm was determined to be 7.8%. The test material has been considered to be essentially non-inhalable.

Executive summary:

The particle size distribution of the test material was determined in accordance with the standardised guideline EUR 20268 under GLP conditions using the sieving method.

An aliquot (14.25 g) of test material 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. Following the shaking period, the mass of the receiver pan and collected test material was recorded and the percentage of test material with a particle size less than 100 μm calculated. As the percentage of the test item that passed through the 100 μm sieve was less than 10%, further testing was not required.

Under the conditions of the study the percentage of test material having an inhalable particle size of less than 100 μm was determined to be 7.8%. The test material has been considered to be essentially non-inhalable.

Description of key information

Fox, 2017

Under the conditions of the study the percentage of test material having an inhalable particle size of less than 100 μm was determined to be 7.8%. The test material has been considered to be essentially non-inhalable.

Additional information

The particle size distribution of the test material was determined in accordance with the standardised guideline EUR 20268 under GLP conditions using the sieving method. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

An aliquot (14.25 g) of test material 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. Following the shaking period, the mass of the receiver pan and collected test material was recorded and the percentage of test material with a particle size less than 100 μm calculated. As the percentage of the test item that passed through the 100 μm sieve was less than 10 %, further testing was not required.

Under the conditions of the study the percentage of test material having an inhalable particle size of less than 100 μm was determined to be 7.8 %. The test material has been considered to be essentially non-inhalable.