1-Propanaminium, N,N,N-trimethyl-3-(octadecyloxy)-, chloride (1:1)

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2 - 3 August 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPPTS 830.7520 (Particle Size, Fiber Length, and Diameter Distribution)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of inspection: 30 August 2005 Date of Signature: 21 November 2005

Type of distribution:

other: cascade impactor method

Test material

Test material information

Constituent 1

Reference substance name:

trimethyl[3-(octadecyloxy)propyl]azanium chloride

EC Number:

700-414-8

Cas Number:

23328-71-4

Molecular formula:

C24H52ClNO

IUPAC Name:

trimethyl[3-(octadecyloxy)propyl]azanium chloride

Constituent 2

Reference substance name:

1-Propanaminium, N,N,N-trimethyl-3-(octadecyloxy)-, chloride

IUPAC Name:

1-Propanaminium, N,N,N-trimethyl-3-(octadecyloxy)-, chloride

Details on test material:

- Name of test material (as cited in study report): 3-Octadecyloxypropyl-N,N,N-trimethylammonium chloride
- Molecular formula (if other than submission substance): Not applicable
- Molecular weight (if other than submission substance): Not applicable
- Smiles notation (if other than submission substance): Not applicable
- InChl (if other than submission substance): Not applicable
- Structural formula attached as image file (if other than submission substance): Not applicable
- Substance type: white solid
- Physical state: solid
- Analytical purity: Not reported
- Impurities (identity and concentrations): Not reported
- Composition of test material, percentage of components: Not reported
- Isomers composition: Not reported
- Purity test date: Not reported
- Lot/batch No.: Exp. I-070518
- Expiration date of the lot/batch: Not reported
- Radiochemical purity (if radiolabelling): Not applicable
- Specific activity (if radiolabelling): Not applicable
- Locations of the label (if radiolabelling): Not applicable
- Expiration date of radiochemical substance (if radiolabelling): Not applicable
- Stability under test conditions: Not reported.
- Storage condition of test material: room temperature in the dark.
- Other: Not reported.

Results and discussion

Particle size

Percentile:

D50

Remarks on result:

other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.

Particle size distribution at different passages

Particle size distribution at different passages 1

No.:

#1

Size:

< 100 µm

Distribution:

18.6 %

Particle size distribution at different passages 2

No.:

#2

Size:

< 10 µm

Distribution:

0.404 %

Particle size distribution at different passages 3

No.:

#3

Size:

< 5.5 µm

Distribution:

0.083 %

Any other information on results incl. tables

Screening test (sieve method)

The results of the sieving procedure are shown in Table 2.

Table 2

Sieve aperture size (µm)	100
Mass of test material transferred to sieve (g)	15.77
Mass of test material passed through sieve (g)	2.94
Test material less than sieve aperture size (%)	18.6

Definitive test (cascade impactor method)

Determination 1

The results of the cascade impactor method are shown in Table 3.

Table 3 Determination 1

Cup Number	ParticleCollected (µm)	Cup Masses (g)
		Pre-sampling	Post-sampling	Difference
1	>10.0	86.1377	88.7089	2.5712
2	5.5 - 10.0	85.4510	85.4536	0.0026
3	2.4 - 5.5	85.9210	85.9215	0.0005
4	1.61 - 2.4	85.5999	85.6000	0.0001
5	0.307 - 1.61	85.7909	85.7910	0.0001
Filter	<0.307	75.1802	75.1802	0

Amount of test material found in artificial throat: 0.61 g.
Total amount of test material recovered from impactor cups, filter and artificial throat: 3.1845 g.

The cumulative amounts found for the individual particle size cut-points (µm) are shown in Table 4.

Table 4 Determination 1

Cup Number	Particle Size Cut-points (µm)	Cumulative Mass of Test Material (g)	Cumulative Amount of Test Material (%)
2	10.0	0.0033	0.104
3	5.5	0.0007	2.20 x 10^-2
4	2.4	0.0002	6.28 x 10^-3
5	1.61	0.0001	3.14 x 10^-3
Filter	0.307	0	0

Determination 2

The results of the cascade impactor method are shown in Table 5.

Table 5 Determination 2

Cup Number	ParticleCollected (µm)	Cup Masses (g)
		Pre-sampling	Post-sampling	Difference
1	>10.0	86.1380	88.8016	2.6636
2	5.5 - 10.0	85.4513	85.4694	0.0181
3	2.4 - 5.5	85.9212	85.9236	0.0024
4	1.61 - 2.4	85.6003	85.6008	0.0005
5	0.307 - 1.61	85.7910	85.7919	0.0009
Filter	<0.307	75.1796	75.1799	0.0003

Amount of test material found in artificial throat: 0.43 g.
Total amount of test material recovered from impactor cups, filter and artificial throat: 3.1158 g.

The cumulative amounts found for the individual particle size cut-points (µm) are shown Table 6.

Table 6 Determination 2

Cup Number	Particle Size Cut-points (µm)	Cumulative Mass of Test Material (g)	Cumulative Amount of Test Material (%)
2	10.0	0.0222	0.712
3	5.5	0.0041	0.132
4	2.4	0.0017	5.46 x 10^-2
5	1.61	0.0012	3.85 x 10^-2
Filter	0.307	0.0003	9.63 x 10^-3

Determination 3

The results of the cascade impactor method are shown in Table 7.

Table 7 Determination 3

Cup Number	ParticleCollected (µm)	Cup Masses (g)
		Pre-sampling	Post-sampling	Difference
1	>10.0	86.1403	89.0288	2.8885
2	5.5 - 10.0	85.4519	85.4615	0.0096
3	2.4 - 5.5	85.9217	85.9229	0.0012
4	1.61 - 2.4	85.5999	85.5999	0
5	0.307 - 1.61	85.7909	85.7921	0.0012
Filter	<0.307	75.181	75.1816	0.0006

Amount of test material found in artificial throat: 0.29 g.
Total amount of test material recovered from impactor cups, filter and artificial throat: 3.1911 g.

The cumulative amounts found for the individual particle size cut-points (µm) are shown in Table 8.

Table 8 Determination 3

Cup Number	Particle Size Cut-points (µm)	Cumulative Mass of Test Material (g)	Cumulative Amount of Test Material (%)
2	10.0	0.0126	0.395
3	5.5	0.0030	9.40 x 10^-2
4	2.4	0.0018	5.64 x 10^-2
5	1.61	0.0018	5.64 x 10^-2
Filter	0.307	0.0006	1.88 x 10^-2

The overall cumulative amounts of test material with a particle size less than 10.0 µm (%) from Determinations 1 to 3 are shown in Table 9.

Table 9

Determination	Cumulative Amount of Test Material Less Than 10.0 µm (%)	Mean Cumulative Amount of Test Material Less Than 10.0 µm (%)
1	0.104	0.404
2	0.712
3	0.395

The overall cumulative amounts of test material with a particle size less than 5.5 µm (%) from Determinations 1 to 3 are shown in Table 10.

Table 10

Determination	Cumulative Amount of Test Material Less Than 5.5 µm (%)	Mean Cumulative Amount of Test Material Less Than 5.5 µm (%)
1	2.20 x 10^-2	8.27 x 10^-2
2	0.132
3	9.40 x 10^-2

Discussion

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

Representative sampling was ensured by rolling the sample container for approximately 10 minutes and sampling from the top, middle and bottom prior to definitive testing.

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.

Applicant's summary and conclusion

Conclusions:

Particle size data acquired for the test material are;
Particle size data acquired for the test material are shown (Sieve method); 18.6%;
Proportion of test material having a thoracic particle size less than 10.0 µm (cascade impactor); 0.404%;and
Proportion of test material having a respirable particle size less than 5.5 µm (cascade impactor); 8.27 x 1.00E-02%.

Executive summary:

Particle size data have been acquired using a procedure designed to comply with the European Commission technical guidance document 'Particle Size Distribution, Fibre Length and Diameter Distribution' (June 1996), which satisfies the requirements of OECD Guideline 110. The results are as follows:

Measurement	Method	Result
Proportion of test material having an inhalable particle size less than 100 µm	Sieve	18.6%
Proportion of test material having a thoracic particle size less than 10.0 µm	Cascade Impactor	0.404%
Proportion of test material having a respirable particle size less than 5.5 µm	Cascade Impactor	8.27 x 10^-2%