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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: 26 October 2017 Experimental completion date: 07 March 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
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 (2002).
GLP compliance:
yes (incl. QA statement)
Type of method:
other: sieve screening followed by cascade impactor
Type of particle tested:
other: powder
Type of distribution:
mass based distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylene bis[1,3-dihydro-1,3-dioxoisobenzofuran-5-carboxylate]
EC Number:
217-062-1
EC Name:
Ethylene bis[1,3-dihydro-1,3-dioxoisobenzofuran-5-carboxylate]
Cas Number:
1732-96-3
Molecular formula:
C20H10O10
IUPAC Name:
2-(1,3-dioxo-1,3-dihydro-2-benzofuran-5-carbonyloxy)ethyl 1,3-dioxo-1,3-dihydro-2-benzofuran-5-carboxylate
impurity 1
Chemical structure
Reference substance name:
Benzene-1,2,4-tricarboxylic acid 1,2-anhydride
EC Number:
209-008-0
EC Name:
Benzene-1,2,4-tricarboxylic acid 1,2-anhydride
Cas Number:
552-30-7
Molecular formula:
C9H4O5
IUPAC Name:
Benzene-1,2,4-tricarboxylic acid 1,2-anhydride
impurity 2
Chemical structure
Reference substance name:
not assignable
IUPAC Name:
not assignable
Specific details on test material used for the study:
Identification: RIKACID TMEG-500
CAS No.: 1732-96-3
Chemical name: Ethylene bis[1,3-dihydro-1,3-dioxoisobenzofuran-5-carboxylate]
Appearance/physical state: cream colored powder
Batch: 5259
Purity: 81.1%
Expiry date: 24 April 2018
Storage conditions: room temperature, in the dark

Results and discussion

Remarks on result:
not determinable
Remarks:
Too few particles were of a size less than 10.0 µm to allow accurate assessment of the mass median aerodynamic diameter.
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 100 µm
Distribution:
34.1 %
Remarks on result:
other: Sieve Screening Test
No.:
#2
Size:
< 10 µm
Distribution:
<= 4.2 %
Remarks on result:
other: Cascade impactor
No.:
#3
Size:
< 5.5 µm
Distribution:
<= 0.8 %
Remarks on result:
other: Cascade impactor

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

17.21 g

Mass of test item passed through sieve

5.86 g

Percentage of test item less than 100 µm

34.1%

 

 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

0.16

0.12

0.07

Cup 1

>10.0

2.8413

2.7293

2.6823

Cup 2

5.5 to 10.0

0.0479

0.1015

0.0965

Cup 3

2.4 to 5.5

0.0020

0.0116

0.0157

Cup 4

1.61 to 2.4

0.0000

0.0028

0.0049

Cup 5

0.307 to 1.61

0.0000

0.0012

0.0022

Final filter

<0.307

0.0003

0.0003

0.0012

Total mass of collected test item

3.0515

2.9667

2.8728

Mass of test item added

3.0941

3.0355

2.9757

 

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 (%)

Det 1

Det 2

Det 3

Det 1

Det 2

Det 3

<10.0

0.0502

0.1174

0.1205

1.6

4.0

4.2

<5.5

0.0023

0.0159

0.0240

0.1

0.5

0.8

<2.4

0.0003

0.0043

0.0083

<0.1

0.1

0.3

<1.61

0.0003

0.0015

0.0034

<0.1

0.1

0.1

<0.307

0.0003

0.0003

0.0012

<0.1

<0.1

<0.1

Overallcumulative percentage with a particle size less than 10.0 µm:   ≤4.2%     

Overallcumulative percentage with a particle size less than 5.5 µm:     ≤0.8%

Discussion

Prior to sampling for the cascade impactor determinations,the test item containerwas rotated forapproximatelytenminutes,before taking aliquotsfrom the top, middle and bottomfor evaluation.

The overall results from the cascade impactor were taken as limit values due to the variation between the sampling positions; thisgavea worst case scenario. Too few particles were of a size less than 10.0 µm to allow accurate assessment of the mass median aerodynamic diameter.

During cascade impactor analysis,determination 1,extremely minor apparent weight losses were recorded for sample cupsnumber 3 and 4 between pre-sample introduction and post-sample introduction weighings. However the magnitude of these deviations in the essentially empty sample cup weights were considered negligible, the largest being only1.4 mg. Critically, with only a total of 1.6% of the test item having been identified as having a particle size <10 µm during determination 1, the weight anomalies identified would have absolutely no influence on the overall limit value of≤4.2% for particles <10 µm reported for the test item.

The inhalable fraction is defined as the mass fraction of particles which may be inhaled by nose or mouth, the thoracic fraction is defined as the mass fraction of particles thatmaypass the larynx and the respirable fraction is defined as the mass fraction of particles that may reach the alveoli.


Applicant's summary and conclusion

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

Percentage of test item with an inhalable particle size <100 µm - Sieve - 34.1%
Percentage of test item with a thoracic particle size <10.0 µm - Cascade impactor - ≤ 4.2%
Percentage of test item with a respirable particle size <5.5 µm - Cascade impactor - ≤ 0.8%
Executive summary:

Particle Size Distribution.Particle size data was acquired, 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). The results are as follows:

 

Measurement

Method

Result

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

Sieve

34.1%

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

Cascade Impactor

≤4.2%

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

Cascade Impactor

≤0.8%