Registration Dossier

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: 17 October 2017. Experimental completion date: 17 January 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:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions) - Method B: Fibre Length and Diameter Distributions
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
determination of fibre length and diameter distributions

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Identification: 1-(methylamino)-4-[(3-methylphenyl)amino] anthraquinone
Physical state/Appearance: dark red powder
Batch: 702W01
Purity: 99.4%
Expiry Date: 08 February 2020
Storage Conditions: room temperature in the dark
Intended use/Application: industrial chemical

Results and discussion

Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 100 µm
Distribution:
79.6 %
No.:
#2
Size:
< 10 µm
Distribution:
1.29 %
No.:
#3
Size:
< 5.5 µm
Distribution:
0.33 %

Any other information on results incl. tables

  Results

  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)

10.07 g

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

8.02 g

Percentage of test item less than 100 µm

79.6%

 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

0.26

0.14

0.44

Sample Cup 1

>10.0

2.6548

2.1417

2.4638

Sample Cup 2

5.5 to 10.0

0.0306

0.235

0.0244

Sample Cup 3

2.4 to 5.5

0.0053

0.0032

0.0043

Sample Cup 4

1.61 to 2.4

0.0030

0.0015

0.0002

Sample Cup 5

0.307 to 1.61

0.0013

0.0019

0.0009

Final Filter

<0.307

0.0018

0.0020

0.0018

Total mass of collected test item

2.9568

2.3138

2.9354

Mass of test item added

2.9625

2.3203

2.9431

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

0.0420

0.0321

0.0316

1.42

1.39

1.08

<5.5

0.0114

0.0086

0.0072

0.39

0.37

0.25

<2.4

0.0061

0.0054

0.0029

0.21

0.23

0.10

<1.61

0.0031

0.0039

0.0027

0.11

0.17

0.09

<0.307

0.0018

0.0020

0.0018

0.06

0.09

0.06

Mean cumulative percentage with a particle size less than 10.0 µm :         1.29
Mean cumulative percentage with a particle size less than 5.5 µm   :         0.33


 

  Discussion

Sampling for the cascade impactor determinations was performed by rolling the test item container for approximately15minutes, andthen samplingfrom the top, middle and bottom.

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

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 item is shown in the following:

Percentage of test item with an inhalable particle size <100 µm (Sieve) = 79.6%
Percentage of test item with a thoracic particle size <10.0 µm (Cascade Impactor) = 1.29%
Percentage of test item with a respirable particle size <5.5 µm (Cascade Impactor) = 0.33%