Quaternary ammonium compounds, C14-18 (even numbered) and C18 unsaturated-alkyl-hydroxyethyl-dimethyl, chlorides

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 November 2016 - 16 August 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

The determination was performed using a procedure designed to be compatible with the European Commission Technical Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002). No deviation affected the quality of the study. The substance is considered to be adequately characterised. Therefore full validation applies.

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

GLP compliance:

yes (incl. QA statement)

Remarks:

UK GLP compliance programme (inspected on 05 July 2016 / signed on 28 Octobre 2016)

Type of method:

cascade impaction

Remarks:

pre-test with Sieving method.

Type of particle tested:

other: free-flowing, soft, fine powder, which forms hard clumps (not easily broken down) of various sizes.

Type of distribution:

mass based distribution

No.:

#1

Size:

< 100 µm

Distribution:

ca. 10 %

Remarks on result:

other: Proportion of test item having an inhalable particle size <100 μm

Remarks:

Sieving

No.:

#2

Size:

< 10 µm

Distribution:

ca. 1.06 %

Remarks on result:

other: Proportion of test item having a thoracic particle size <10.0 μm

Remarks:

Cascade Impactor

No.:

#3

Size:

< 5.5 µm

Distribution:

ca. 0.044 %

Remarks on result:

other: Proportion of test item having a respirable particle size <5.5 μm

Remarks:

Cascade Impactor

Results

Sieving Screening Test

The results of the sieving procedure are:

Mass of test item transferred to sieve 11.85 g

Mass of test item passed through sieve 1.19 g

Proportion of test item <100 μm 10.0%

Cascade Impactor Method

The results of the cascade impactor determinations are shown in the tables on the experimetal report.

(Negligible negative mass differences have not been considered for the calculations and are presented as 0.00 in tables).

Determination 1:

Mass of test item found in artificial throat: 0.17 g.

Total mass of test item recovered from artificial throat, sample cups and filter: 3.0118 g.

Detemination 2:

Mass of test item found in artificial throat: 0.25 g.

Total mass of test item recovered from artificial throat, sample cups and filter: 3.0710 g.

Determination 3:

Mass of test item found in artificial throat: 0.58 g.

Total mass of test item recovered from artificial throat, sample cups and filter: 2.9929 g.

The cumulative amounts of test item found in the three determinations for the individual particle size cut-points are shown in tables in the experimental report.

The overall cumulative percentage (%) of test item with a particle size less than 10.0 μm and 5.5 μm are shown in the following table:

Particle Size	Cumulative Percentage (%)
	Determination 1	Determination 2	Determination 3	Mean
<10.0 μm	0.528	0.840	1.81	1.06
<5.5 μm	7 x 10-3	7.5 x 10-2	5.0 x 10-2	4.4 x 10-2

 

Discussion

Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter.

Sampling for the cascade impactor determinations was performed by rolling the test item container for approximately 10 minutes and then sampling from the top (determination 1), middle (determination 2) and bottom (determination 3).

Conclusions:

Proportion of test item having an inhalable particle size <100 μm =10.0%Proportion of test item having a thoracic particle size <10.0 μm=1.06%Proportion of test item having a respirable particle size <5.5 μm= 0.044%

Executive summary:

The particle size distribution is evaluated based on internationally accepted guidelines. 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. These individual fractions are estimated as follows:

Measurement	Method	Result
Proportion of test item having an inhalable particle size <100μm	Sieving	10.0%
Proportion of test item having a thoracic particle size <10.0μm	Cascade Impactor	1.06%
Proportion of test item having a respirable particle size <5.5μm	Cascade Impactor	4.4 x 10-2%

Description of key information

Proportion of test item having an inhalable particle size <100 μm =10.0%

Proportion of test item having a thoracic particle size <10.0 μm=1.06%

Proportion of test item having a respirable particle size <5.5 μm= 0.044%

Additional information

The particle size distribution is evaluated based on internationally accepted guidelines. 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. These individual fractions are estimated as follows:

Measurement	Method	Result
Proportion of test item having an inhalable particle size <100μm	Sieving	10.0%
Proportion of test item having a thoracic particle size <10.0μm	Cascade Impactor	1.06%
Proportion of test item having a respirable particle size <5.5μm	Cascade Impactor	4.4 x 10-2%