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Diss Factsheets

Physical & Chemical properties

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

Constituent 1
Chemical structure
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 passagesopen allclose all
No.:
#1
Size:
< 100 µm
Distribution:
ca. 24.8 %
No.:
#2
Size:
< 10 µm
Distribution:
ca. 6.96 %
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%