N-(2-hydroxyethyl)dodecanamide

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:

17 August 2017 - TBC

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study was conducted in accordance with international guidelines and in accordance with GLP. All guideline validity criteria were met.

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

Version / remarks:

2002

GLP compliance:

yes (incl. QA statement)

Type of method:

sieving

Type of particle tested:

primary particle

Type of distribution:

mass based distribution

Remarks on result:

not determinable because of methodological limitations

Remarks:

In accordance with the European Commission’s Joint Research Centre’s Guidance Document on the Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances (EUR 20268) (Section 4.2) sieving is not suitable to determine the distribution of particle of respirable size. This method cannot determine the MMAD.

Key result

Percentile:

other: The percentage of test item having an inhalable particle size of less than 100 µm was determined to be 1.28%.

Mean:

>= 100 µm

Remarks on result:

other: Standard deviation: not determined.

No.:

#1

Size:

<= 100 µm

Distribution:

<= 1.28 %

Evaluation of Data:

The percentage of test item (P, % w/w) that passed through the sieve was calculated using Equation1:

 

Equation 1:

P = ((W₃– W₂)/W₁) x 100

 

Where:

W₁= mass of test item transferred to the sieve (g)

W₂= mass of the empty receiver pan (g)

W₃= mass of the receiver pan and collected test item (g)

 

 

Results (Screening Test):

The results of the sieving procedure are shown in Table 1.

 

Table 1:          Screening Test Results

Measurement	Result
Mass of test item transferred to sieve	15.85 g
Mass of test item passed through sieve	0.14 g
Percentage of test item less than 100 µm	1.28%

 

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.

Conclusions:

The percentage of test item having an inhalable particle size of less than 100 µm was determined to be 1.28%. The test item has been considered to be essentially non-inhalable.

Executive summary:

EUR 20268 – The granulometry of the test item was determined using the sieving method.  The procedure employed was designed to be compatible with the European Commission’s Joint Research Centre’s Guidance Document on the Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances (EUR 20268) (2002).

An aliquot (10.96 g) of test item 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 the sieve shaker for a period of approximately 30 minutes.  The sieve shaker table, on which the sieve rests, had an inclination of 4.5°, a nominal rotation speed of 2.5 rpm and vibrated at approximately 300 oscillations/min with an approximately 4 mm amplitude.  Following the shaking period, the mass of the receiver pan and collected test item was recorded and the percentage of test item with a particle size less than 100 µm calculated.

The percentage of test item having an inhalable particle size of less than 100 µm was determined to be 1.28%.  The test item has been considered to be essentially non-inhalable

Description of key information

Particle Size Distribution: Particle size of less < 100 µm = 1.28%; EUR 20268; R. Butler (2018)

Additional information

EUR 20268 – The granulometry of the test item was determined using the sieving method.  The procedure employed was designed to be compatible with the European Commission’s Joint Research Centre’s Guidance Document on the Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances (EUR 20268) (2002).

An aliquot (10.96 g) of test item 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 the sieve shaker for a period of approximately 30 minutes.  The sieve shaker table, on which the sieve rests, had an inclination of 4.5°, a nominal rotation speed of 2.5 rpm and vibrated at approximately 300 oscillations/min with an approximately 4 mm amplitude.  Following the shaking period, the mass of the receiver pan and collected test item was recorded and the percentage of test item with a particle size less than 100 µm calculated.

The percentage of test item having an inhalable particle size of less than 100 µm was determined to be 1.28%.  The test item has been considered to be essentially non-inhalable