Dodeca (lithium, sodium)-2-({4-[4-(4-{bis[alkyl-(sulfonatoalkoxy)-4-({-sulfonato-[(substituted-phenyl)diazenyl]phenyl} diazenyl)anilino]-triazin-yl}-6-[alkyl-(sulfonatoalkoxy)-4-(sulfonato--[(substituted-phenyl)diazenyl]phenyl)diazenyl)anilino]piperazin-yl)-triazin-ylamino]-alkyl-5-(sulfonatoalkoxy)phenyl}diazenyl)-5-[(sulfonatophenyl)diazenyl]benzensulfonate

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 January 2011 - 22 February 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study has been performed according to ISO and CIPAC guidelines and in compliance with GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: ISO 13320:2009

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187

Deviations:

not specified

Test guideline 3

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Type of distribution:

volumetric distribution

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): E-BW102
- Description: Reddish brown powder
- Batch: MB-1
- Test substance storage: At room temperature protected from light
- Stability under storage conditions: Stable
- Expiry date: 23 December 2015

Results and discussion

Particle size

Particle size 1

Percentile:

D50

Mean:

59.807 µm

Remarks on result:

other: average of 5 runs, result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean (% STDV=2.51) (migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)

Particle size 2

Percentile:

D50

Mean:

47.884 µm

St. dev.:

1.2

Remarks on result:

other: average of 5 runs (see also remark MMAD)

Particle size distribution at different passages

Particle size distribution at different passages 1

No.:

#1

Size:

< 6.689 µm

Distribution:

10 %

Remarks on result:

other: by volume of sample

Particle size distribution at different passages 2

No.:

#2

Size:

< 10 µm

Distribution:

15.83 %

Remarks on result:

other: by volume of sample

Particle size distribution at different passages 3

No.:

#3

Size:

< 47.884 µm

Distribution:

50 %

Remarks on result:

other: by volume of sample

Particle size distribution at different passages 4

No.:

#4

Size:

< 170.119 µm

Distribution:

90 %

Remarks on result:

other: by volume of sample

Any other information on results incl. tables

Visual and microscopic evaluation of the sample:

1. standard visual observation

- sample observed to contain fine, medium and gritty particules with clusters

2. microscope analysis (100x magnification)

- the particles appeared to be irregular shaped crystals

- the smallest individual particle size was approx. 3.2 µm and the largest individual size was approx. 409.6 µm

3. microscope analysis (400x magnification)

- sample was observed to be made up of agglomerated crystalline particles

Applicant's summary and conclusion

Conclusions:

The MMAD of the test substance was determined to be 59.807 µm using Laser Diffraction Particle Size Analysis with a 'wet', small volume dispersion system. The median (D50) was determined as 47.884 µm. 15.83 % by volume of sample was seen to be < 10.00 µm.