Disodium {sulfonylbis[4,1-phenylenediazene-2,1-diyl(1-ethyl-6-hydroxy-4-methyl-2-oxo-1,2-dihydropyridine-5,3-diyl)]}dimethanesulfonate

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experimental Starting Date: October 26, 2010 Experimental Completion Date: November 03, 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: European Commission ECB/TM/Feb. 1996

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: European Commission EUR 20268 EN (2002), DRAFT, Part. 5.2

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of distribution:

other: Laser diffraction method

Test material

Test material information

Constituent 1

Reference substance name:

Acid Yellow RN 2903

IUPAC Name:

Acid Yellow RN 2903

Details on test material:

Identification: Acid Yellow RN 2903
Batch Number: Vers. Kilo 6, 26.05.2009
Purity: 65.7 %
Expiry Date: August 01, 2015
Storage Conditions: At room temperature at about 20 °C

Results and discussion

Particle size

Particle size 1

Percentile:

D50

Mean:

17.9 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:

other: 5%

Mean:

< 1.6 µm

St. dev.:

0.038

Particle size 3

Percentile:

other: 10%

Mean:

< 3.4 µm

St. dev.:

0.091

Particle size 4

Percentile:

other: 50%

Mean:

< 17.9 µm

St. dev.:

0.352

Particle size 5

Percentile:

other: 90%

Mean:

< 46.6 µm

St. dev.:

3.657

Any other information on results incl. tables

Acid Yellow RN 2903 is a fine dark yellow powder. Under the microscope (with a magnification of 100), small-sized orange colored crystals with some major crystals were observed.

 

A solubility test showed, that the test item is both: sparingly soluble and well dispersible in 2-propanol. The particle size distribution of Acid Yellow RN 2903 was performed with two samples of the stock dispersion each measured in duplicate.

 

The individual measurements and the results obtained using the laser diffraction method of Acid Yellow RN 2903 are summarized in Table1 and Table 2. The tables represent rounded results obtained by using the exact measurement data. An example of the particle size distribution curve is shown in the attached Figure1.

 

The results obtained during the measurements showed no relevant difference. Therefore the study is considered to be valid and no further testing is necessary.

Table 1       Particle Size Distribution of Acid Yellow RN 2903

	1^stRun Particle Size	2^ndRun Particle Size	3^rdRun Particle Size	4^thRun Particle Size	Mean Particle Size	Stand. Dev. ±
[%]	[µm]	[µm]	[µm]	[µm]	[µm]	[µm]
5	< 1.64	< 1.67	< 1.58	< 1.61	< 1.6	0.038
10	< 3.39	< 3.48	< 3.31	< 3.28	< 3.4	0.091
50	< 17.83	< 18.23	< 17.44	< 18.12	< 17.9*	0.352
90	< 48.79	< 49.97	< 41.78	< 45.71	< 46.6	3.657

 

*) The MMDof the test item indicates that 50% (by mass) of the particles are smaller than 17.9 µm.

Table 2        Particle Size Distribution of Acid Yellow RN 2903 in [%] at the relevant Particle Size

[µm]	1^stRun	2^ndRun	3^rdRun	4^thRun	Mean	Stand. Dev.
	[%]	[%]	[%]	[%]	[%]	[%]
< 0.3	*****	*****	*****	*****
< 0.5	1.50	1.50	1.50	1.50	1.50	0.00
< 1.0	3.20	3.20	3.30	3.20	3.23	0.05
< 2.0	6.00	5.80	6.20	6.20	6.05	0.19
< 3.0	8.80	8.60	9.10	9.10	8.90	0.24
< 4.0	11.90	11.60	12.20	12.30	12.00	0.32
< 5.0	15.20	14.90	15.40	15.50	15.25	0.26
< 6.0	18.60	18.30	18.80	18.70	18.60	0.22
< 7.0	21.80	21.50	22.10	21.90	21.83	0.25
< 8.0	25.00	24.60	25.30	24.90	24.95	0.29
< 9.0	28.10	27.60	28.40	27.90	28.00	0.34
< 10.0	31.00	30.50	31.30	30.70	30.88	0.35
< 20.0	54.40	53.60	55.70	53.90	54.40	0.93
< 30.0	71.50	70.60	75.00	72.10	72.30	1.90
< 40.0	83.30	82.40	88.30	84.90	84.73	2.60
< 50.0	90.80	90.00	95.50	92.70	92.25	2.44
< 60.0	95.20	94.60	98.80	96.90	96.38	1.89
< 70.0	97.70	97.30	99.90	99.00	98.48	1.20
< 80.0	99.20	98.80	100.00	100.00	99.50	0.60
< 90.0	99.90	99.70	100.00	100.00	99.90	0.14
< 100.0	100.00	100.00	100.00	100.00	100.00	0.00
< 125.0	100.00	100.00	100.00	100.00	100.00	0.00
< 150.0	100.00	100.00	100.00	100.00	100.00	0.00
< 175.0	100.00	100.00	100.00	100.00	100.00	0.00
< 200.0	100.00	100.00	100.00	100.00	100.00	0.00
< 225.0	100.00	100.00	100.00	100.00	100.00	0.00
< 250.0	100.00	100.00	100.00	100.00	100.00	0.00
< 275.0	100.00	100.00	100.00	100.00	100.00	0.00
< 300.0	*****	*****	*****	*****

 

Applicant's summary and conclusion

Conclusions:

In conclusion, using the laser diffraction method to study the particle size of Acid Yellow RN 2903 ranging between 0.3 µm and 300 µm, the mass median diameter (MMD) was determined to be 17.9 µm. The particle size distribution was found to range from approximately 0.3 µm to 100.0 µm.

Executive summary:

Using the laser diffraction method to study the particle size of Acid Yellow RN 2903 ranging between 0.3 µm and 300 µm, the mass median diameter (MMD) was determined to be

 

17.9 µm.

 

The particle size distribution was found to range from approximately 0.3 µm to 100.0 µm.