1-hydroxy-4-(p-toluidino)anthraquinone

Particle size distribution (Granulometry)

Link to relevant study record(s)

Reference

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions) - Method B: Fibre Length and Diameter Distributions

GLP compliance:

yes (incl. QA statement)

Type of method:

sieving

Type of distribution:

mass based distribution

Mass median aerodynamic diameter:

13.58 µm

Percentile:

D50

Mean:

13.58 µm

Remarks on result:

other: spherical volume

No.:

#1

Size:

>= 4 - < 10 µm

Distribution:

0.11 %

Remarks on result:

other: spherical volume

No.:

#2

Size:

>= 10 - < 100 µm

Distribution:

2.49 %

Remarks on result:

other: spherical volume

Result: Sieve Fraction (<100μm)

- weighted sample: 0.9173 g

- weight fraction <100 μm: 0.0238 g

- mass fraction <100 μm: 2.59 %

The mass fraction <100 µm was 2.59 %, and was investigated by scanning electron microscopy. The mean diameter (median) was 10.95 µm with 6.85 µm standard deviation. The median aspect ratio (median) was 1.55 with 0.37 as standard deviation.

The median diameter (mass fraction) of the particle size is given for the fraction <100 µm. The value 13.58 µm was calculated for spherical particles as MMAD (Mass Median Aerodynamic Diameter).

Particle Size	Spherical Volume [%]	Cubical Volume [%]
< 4 µm (respirable)	0.04	0.05
4 - 10 µm (thoracic)	4.06	5.04
10 - 100 µm (inhalable)	95.9	94.91
> 100 µm	0.0	0.0
Median (diameter µm)	13.58	13.47

Conclusions:

The MMAD (Mass Median Aerodynamic Diameter) < 100 µm of Solvent Violet 13 has a value of 13.58 µm as spherical particles.

Executive summary:

According to OECD guideline 110, method B, the particle size distribution of Solvent Violet 13 was determined by scanning electron microscopy method for the sieved fraction (<100 µm, 2.59 % of total sample) and presented on the basis of calculated mass fractions.

The MMAD (Mass Median Aerodynamic Diameter) <100 µm was 13.58 µm with the main fraction of 2.59 % spherical volume distributing in the range of 10 - 100 µm and hence the tested particles with sieved size smaller than 100 µm are mainly dominated by inhalable fraction as defined in EU 481.

Description of key information

According to OECD guideline 110, method B, the particle size distribution of Solvent Violet 13 was determined by scanning electron microscopy method for the sieved fraction (<100 µm, 2.59 % of total sample) and presented on the basis of calculated mass fractions.

The MMAD (Mass Median Aerodynamic Diameter) <100 µm was 13.58 µm with the main fraction of 2.59 % spherical volume distributing in the range of 10 - 100 µm and hence the tested particles with sieved size smaller than 100 µm are mainly dominated by inhalable fraction as defined in EU 481.