2-((E)-(4-((4-(1,3-dioxo-1,3-dihydro-2H-hetereocarbapolycyclo-2-yl)alkyl)(ethyl)amino)-2-methyl)diazenyl)-5-nitro-1,3-dicarbonitrile, polyphenyl

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

200-09-18

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: EUROPEAN COMMISSION, Directorate General XII-JRC, Science Research and Development-Joint Research Centre. “Particle Size Distribution, Fibre Length and Diameter Distribution” Guidance Document, ECB/TM/February 1996

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EUROPEAN COMMISSION, Directorate General JRC, Joint Research Centre. “Particle Size Distribution, Fibre Length and Diameter Distribution” Draft Guidance Document, EUR 20268 EN (2002), Part 5.2 “Laser scattering / diffraction”.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of distribution:

other: laser diffraction

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of the test material (as cited in the study report: FAT 40842/A TE
- Substance type: coloring dye
- Physical state: solid, dark bluish green powder
- Analytical purity: 96%
- Lot/batch No.: Blau DRI 2098 Op 1/07
- Expiration date of the lot/batch: June 30, 2014
- Storage condition of test material: at room temperature at about 20 ºC

Results and discussion

Particle size

Particle size 1

Percentile:

D50

Mean:

9.3 µm

Remarks on result:

other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.

Particle size 2

Percentile:

D10

Mean:

< 2.69 µm

St. dev.:

0.186

Particle size 3

Percentile:

D50

Mean:

< 9.11 µm

St. dev.:

0.788

Particle size 4

Percentile:

D90

Mean:

< 23.87 µm

St. dev.:

2.07

Any other information on results incl. tables

Visual Examination

Visual examinations were performed macroscopically and microscopically under magnification of 100, using a light microscope LEITZ, DIALUX 20, to judge the color and the structure of the test item. For the examination under the microscope, the test item was dispersed in 2-propanol placed on a slide and covered with a second slide. FAT 40842/A TE is a greenish, fine powder and rod-shaped structures were observed.

Main Test

The dispersing apparatus was rinsed and filled with water. A few mL of the stock dispersion were added slowly until the absorption of the laser was reduced by about 10%. The particle size distribution in the suspension was quantified by laser diffraction. The test was performed with two samples of the stock dispersion and each measured in duplicate.

Data Handling

A particle size distribution curve was prepared in the range between 0.3 μm and 300 μm. The mass median diameter (MMD) of FAT 40842/A TE, which is the particle size [μm] not exceeded by 50% (by mass) of the particles, was calculated. In other words 50% of the total sample mass is presented in particles having a diameter smaller than the value determined.

Particle Size Distribution of FAT 40842/A TE

 

	1stRun	2ndRun	3rdRun	4thRun	Mean	Stand. Dev.
	Particle Size	Particle Size	Particle Size	Particle Size	Particle Size
%	[μm]	[μm]	[μm]	[μm]	[μm]	± [μm]
5	< 1.88	< 2.16	< 1.87	< 2.00	< 2.0	0.134
10	< 2.69	< 3.06	< 2.65	< 2.81	< 2.8	0.186
50	< 9.11	< 10.43	<8.56	<9.22	<9.3*	0.788
90	< 23.87	< 27.19	< 22.22	< 24.30	< 24.4	2.070

*) The MMD of the test item indicates that 50% (by mass) of the particles are smaller than

9.3μm.

Applicant's summary and conclusion

Conclusions:

In conclusion, using the laser diffraction method to study the particle size of FAT 40842/A TE ranging between 0.3 μm and 300 μm, the mass median diameter (MMD) was determined to be 9.3 μm.
The particle size distribution was found to range from approximately 0.3 μm to 50 μm.

Executive summary:

The determination of the particle size distribution of FAT 40842/A TE was performed according to the European Commission, Document ECB/TM/February 1996: ”Particle Size Distribution, Fibre Length and Diameter Distribution” Guidance Document and the EUROPEAN COMMISSION, Directorate General JRC, Joint Research Centre. “Particle Size Distribution, Fibre Length and Diameter Distribution” Draft Guidance Document, EUR 20268 EN (2002), Part 5.2 “Laser scattering / diffraction” using the laser diffraction method.

FAT 40842/A TE is a greenish, fine powder. Under the microscope (with a magnification of 100) rod-shaped structures were observed.

A solubility test showed, that the test item is both: sparingly soluble and well dispersible in water. The particle size distribution of FAT 40842/A TE was performed with two test item samples dispersed in water each measured in duplicate.

Using the laser diffraction method to study the particle size of FAT 40842/A TE ranging between 0.3 μm and 50 μm, the mass median diameter (MMD) was determined to be 9.3 μm. The particle size distribution was found to range from approximately 0.3 μm to 50 μm.