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Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experiment start date - 06 November 2020; Experiment end date - 22 January 2021.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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
Specific details on test material used for the study:
Identification: 4-Hydroxycoumarin
CAS Number: 1076-38-6
Appearance/Physical State: Beige powder
Batch Number: HCN20002
Purity: > 99%
Expiry Date: 26 September 2022
Storage Conditions: Room temperature, in the dark
No.:
#1
Size:
< 100 µm
Distribution:
95.1 %
Remarks on result:
other: Sieving method
No.:
#2
Size:
< 10 µm
Distribution:
<= 0.674 %
Remarks on result:
other: Cascade impactor
No.:
#3
Size:
< 5.5 µm
Distribution:
<= 0.187 %
Remarks on result:
other: Cascade impactor

Sieve Screening Test

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

 

Measurement

Result

Mass of test item transferred to sieve (W1)

11.90 g

Mass of test item passed through sieve (W3– W2)

11.32 g

Percentage of test item less than 100 µm

95.1%

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

0.25

0.28

0.16

Sample Cup 1

>10.0

2.6235

2.6773

2.8583

Sample Cup 2

5.5 to 10.0

0.0141

0.0101

0.0006

Sample Cup 3

2.4 to 5.5

0.0031

0.0008

0.0009

Sample Cup 4

1.61 to 2.4

0.0016

0.0002

0.0006

Sample Cup 5

0.307 to 1.61

0.0004

0.0003

0.0009

Final Filter

<0.307

0.0003

0.0000

0.0000

Total mass of collected test item

2.8930

2.9687

3.0213

Mass of test item added

2.9412

2.9836

3.0058

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 Points (µm)

Cumulative Mass (g)

Cumulative Percentage (%)

Determination 1

Determination 2

Determination 3

Determination 1

Determination 2

Determination 3

<10.0

0.0195

0.0114

0.0030

0.674

0.384

0.099

<5.5

0.0054

0.0013

0.0024

0.187

0.044

0.079

<2.4

0.0023

0.0005

0.0015

0.080

0.017

0.050

<1.61

0.0007

0.0003

0.0009

0.024

0.010

0.030

<0.307

0.0003

0.0000

0.0000

0.010

0.000

0.000

Overall cumulative percentage with a particle size less than 10.0 µm: ≤ 0.674

Overall cumulative percentage with a particle size less than 5.5 µm: ≤ 0.187

Conclusions:
Proportion of test item having an inhalable particle size <100 µm (Sieve method): 95.1%
Proportion of test item having a thoracic particle size <10.0 µm (Cascade Impactor): ≤ 0.674%
Proportion of test item having a respirable particle size <5.5 µm (Cascade Impactor): ≤ 0.187%
Executive summary:

The particle size distribution of the test subtance was evaluated in a study conducted according to European Commission Guidance Document EUR 20268 'Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances' (2002).

Seiving method and Cascade impaction method was used for this purpose.

The results are as follows:

Measurement

Method

Result

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

Sieve

95.1%

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

Cascade Impactor

≤ 0.674%

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

Cascade Impactor

≤ 0.187%

Description of key information

The particle size distribution of the test subtance was evaluated in a study conducted according to European Commission Guidance Document EUR 20268 'Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances' (2002).

Seiving method and Cascade impaction method was used for this purpose.

The results are as follows:

Measurement

Method

Result

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

Sieve

95.1%

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

Cascade Impactor

≤ 0.674%

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

Cascade Impactor

≤ 0.187%

Additional information