2-ethoxy-4-(hydroxymethyl)phenol

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experimental starting date: 31 July 2016 Experimental completion date: 12 October 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

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’ (2002).

Deviations:

no

GLP compliance:

yes

Type of method:

cascade impaction

Type of particle tested:

primary particle

Type of distribution:

mass based distribution

Test material

Test material information

Constituent 1

Reference substance name:

2-ethoxy-4-(hydroxymethyl)phenol

EC Number:

674-192-5

Cas Number:

4912-58-7

Molecular formula:

C9H12O3

IUPAC Name:

2-ethoxy-4-(hydroxymethyl)phenol

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Information as provided by the Sponsor. The Certificate of Analysis provided by the Sponsor is presented as.

Identification: EVA
Common name: ETHYLVANILLYL ALCOHOL, White Vanilla
CAS Number: 4912-58-7
CAS Name: Benzenemethanol, 3-ethoxy-4-hydroxy-
Chemical Name: 2- Ethoxy-4-(hydroxymethyl)phenol
Appearance/Physical state: Pale yellow powder
Batch: 4K0001
Purity: 100%
Expiry date: 31 December 2017
Storage conditions: Room temperature in the dark

Results and discussion

Remarks on result:

not determinable

Particle size distribution at different passages

Particle size distribution at different passages 1

No.:

#1

Size:

< 100 µm

Distribution:

ca. 24.8 %

Particle size distribution at different passages 2

No.:

#2

Size:

< 10 µm

Distribution:

ca. 6.96 %

Particle size distribution at different passages 3

No.:

#3

Size:

< 5.5 µm

Distribution:

ca. 1.68 %

Any other information on results incl. tables

Sieve Screening Test

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

Measurement	Result
Mass of test item transferred to sieve	12.64 g
Mass of test item passed through sieve	3.14 g
Percentage of test item less than 100 µm	24.8 %

Cascade Impactor

The results of the cascade impactor procedure are shown in the following table:

Collection stage	Particle size range collected (µm)	Collected mass (g)
		Determination 1	Determination 2	Determination 3
Artificial throat	n/a	0.02	0.06	0.02
Cup 1	>10.0	2.6832	2.5013	2.6474
Cup 2	5.5 to 10.0	0.1259	0.1741	0.1495
Cup 3	2.4 to 5.5	0.0181	0.0315	0.0239
Cup 4	1.61 to 2.4	0.0045	0.0080	0.0067
Cup 5	0.307 to 1.61	0.0033	0.0044	0.0042
Final filter	<0.307	0.0102	0.0156	0.0121
Total mass of collected test item		2.8652	2.7949	2.8638
Mass of test item added		3.0044	2.9993	3.0404

The cumulative amounts of test item collected in the three determinations for the individual particle size cut-points are shown in the following table:

Particle size cut point (µm)	Cumulative mass (g)			Cumulative percentage (%)
	Determination 1	Determination 2	Determination 3	Determination 1	Determination 2	Determination 3
<10.0	0.1620	0.2336	0.1964	5.65	8.36	6.86
<5.5	0.0361	0.0595	0.0469	1.26	2.13	1.64
<2.4	0.0180	0.0280	0.0230	0.63	1.00	0.80
<1.61	0.0135	0.0200	0.163	0.47	0.72	0.57
<0.307	0.0102	0.0156	0.0121	0.36	0.56	0.42

Mean cumulative percentage with a particle size less than 10.0 μm : 6.96

Mean cumulative percentage with a particle size less than 5.5 μm : 1.68

Applicant's summary and conclusion

Conclusions:

Particle size data acquired for the test item is shown as follows:

Measurement Method Result
Percentage of test item with an inhalable particle size <100 μm Sieve 24.8%
Percentage of test item with a thoracic particle size <10.0 μm Cascade impactor 6.96%
Percentage of test item with a respirable particle size <5.5 μm Cascade impactor 1.68%

Executive summary:

The determination was carried out using a procedure designed to be compatible with that given in European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002).

Particle size data acquired for the test item is shown in the following table:

Measurement	Method	Result
Percentage of test item with an inhalable particle size <100 µm	Sieve	24.8%
Percentage of test item with a thoracic particle size <10.0 µm	Cascade Impactor	6.96%
Percentage of test item with a respirable particle size <5.5 µm	Cascade Impactor	1.68%