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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:
07 November 2018 to 04 December 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
other: procedure designed to be compatible with European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002).
GLP compliance:
yes (incl. certificate)
Type of method:
sieving
Type of particle tested:
primary particle
Type of distribution:
mass based distribution
Specific details on test material used for the study:
Test item: Acid Orange 94 Refined
Alternative name: Disodium 5, 5’-[(1-methylethylidene)bis(4,1-phenyleneoxysulphonyl-2,1-phenyleneazo)]bis[6-aminonaphthalene-1-sulphonate]
CAS number: 70161-18-1
EC number: 274-354-1
Intended use: Industrial chemical
Appearance: Reddish brown crystals
Storage conditions: Room temperature (10 – 30C), in the dark
Lot number: 8009
Expiry/Retest date: 31 December 2019
Purity: 97%
Remarks on result:
other:
Remarks:
Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter.
No.:
#1
Size:
100 µm
Distribution:
1.29 %
Remarks on result:
other:
Remarks:
procedure designed to be compatible with European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002).

Sieve Screening Test

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

Table 18 

 Measurement    

 Result

Mass of test item transferred to sieve (W1)

 15.57 g

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

 0.20 g

 Percentage of test item less than 100 μm

 1.29%

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.

Conclusions:
The percentage of test item having an inhalable particle size of less than 100 μm was determined to be 1.29%. The test item has been considered to be essentially non-inhalable.
Executive summary:

The particle size distribution was determined by a seive method 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), in accordance with GLP.

There were too few particles of a size less than 10.0 μm to allow for an 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.

As percentage of test item having an inhalable particle size of less than 100 μm was determined to be 1.29%. The test item has been considered to be essentially non-inhalable.

Description of key information

The particle size distribution was determined by a seive method 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), in accordance with GLP.

There were too few particles of a size less than 10.0 μm to allow for an 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.

As percentage of test item having an inhalable particle size of less than 100 μm was determined to be 1.29%. The test item has been considered to be essentially non-inhalable.

Additional information