Tetrasodium 8-[[4-[(4-amino-3-sulphonatophenyl)azo]-6-sulphonatonaphthyl]azo]-5-[[6-(benzoylamino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-2-sulphonate

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

Study period:

1.12.2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: Guidance Document on the Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances, EUR 20268 EN (2002).

Deviations:

no

Qualifier:

according to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Version / remarks:

First edition 2009-10-01

Principles of method if other than guideline:

The laser diffraction based on the Mie-scattering theory was selected for determination.A representative sample, dispersed at an adequate concentration in a suitable liquid, is passed through the beam of a monochromatic light source (laser). A multi-element detector measures the light scattered by the particles at various angles and numerical values relating to the scattering pattern are then recorded for subsequent analysis. These numerical scattering values are then transformed, using an appropriate optical model and mathematical procedure (Mie theory), to yield the proportion of total volume to a discrete number of size classes forming a volumetric particle size distribution

GLP compliance:

no

Type of method:

Laser scattering/diffraction

Type of particle tested:

primary particle

Type of distribution:

volumetric distribution

Mass median aerodynamic diameter:

30.6 µm

Geometric standard deviation:

0.2

Percentile:

D90

Mean:

54.5 µm

St. dev.:

0.7

Percentile:

D10

Mean:

13.8 µm

St. dev.:

0.2

Table No.1:Results of determination of particle size distribution

Determination	Median (mm)	Diameter on Cumulative 90% (mm)	Diameter on Cumulative 10% (mm)	Span (-)
1	30.8	55.7	14.0	1.4
2	30.6	53.9	14.1	1.3
3	30.8	54.4	14.0	1.3
4	30.4	55.1	13.6	1.4
5	30.6	54.5	13.8	1.3
Average	30.6	54.7	13.9	1.3
Standard deviation	0.2	0.7	0.2	0.0
Extended uncertainty	0.4	1.4	0.4	-

The value nearest to average was use as the final result of the test. That was the 5^rd measurement.

Standard uncertainty is equal to one standard deviation.

Extended uncertainty was calculated by using coefficient 2.

Conclusions:

see Executive Summary

Executive summary:

The particle size distribution of the test substance, Direct Blue 85 was determined. The laser diffraction method was used.

The procedures used in the study were in accordance with:

Guidance Document on the Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances, EUR 20268 EN (2002).

Standard ISO 13320: 2009 Particle size analysis – Laser diffraction methods, First edition 2009-10-01.

Particle size distribution of test substance, Direct Blue 85, is characterized by the following table:

Determination	Median (um)	Diameter on Cumulative 90% (um)	Diameter on Cumulative 10% (um)	Span (-)
Final result	30.6	54.5	13.8	1.3
Extended uncertainty	0.4	1.4	0.4	-

Extended uncertainty was calculated by using a coverage factor of 2.

Description of key information

The laser diffraction method was used in accordance with:

Guidance Document on the Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances, EUR 20268 EN (2002).

Standard ISO 13320: 2009 Particle size analysis – Laser diffraction methods, First edition 2009-10-01.

Additional information

Determination	Median (um)	Diameter on Cumulative 90% (um)	Diameter on Cumulative 10% (um)	Span (-)
Final result	30.6	54.5	13.8	1.3
Extended uncertainty	0.4	1.4	0.4	-