3,10-diamino-6,13-dichloro-2-((6-(((4-(1,1-dimethylethyl)phenyl)sulfonyl)amino)-2-naphthalenyl)sulfonyl)-4,11-triphenodioxazinedisulfonic acid, lithium potassium sodium salt

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:

August 20, 2001 - March 27, 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: EUROPEAN COMMISSION, Directorate General Xl¡-JRC, Science Research and Development-Joint Research Centre. "Particle Size Distribution, Fibre Length and Diameter Distribution" Guidance Document, ECB/TM/February 1 996.

Qualifier:

equivalent or similar to guideline

Guideline:

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

Version / remarks:

The laser scattering / diffraction method has been applied. As specified in OECD TG 110, there is no standard procedure for method B (fibre length and diameter distributions). The sample preparation for method B suggested in OECD TG 110 is different from the one followed in the current study but this is not a major deviation. Quality criteria for repeatability (measurement in duplicate) and sensitivity (diameter between 0.2 and 300 µm) are met.

Principles of method if other than guideline:

The laser scattering / diffraction method has been applied. As specified in OECD TG 110, there is no standard procedure for method B (fibre length and diameter distributions). The sample preparation for method B suggested in OECD TG 110 is different from the one followed in the current study but this is not a major deviation. Quality criteria for repeatability (measurement in duplicate) and sensitivity (diameter between 0.2 and 300 µm) are met.

GLP compliance:

yes

Type of method:

Laser scattering/diffraction

Type of particle tested:

other: not specified

Type of distribution:

other: mass median diameter

Mass median aerodynamic diameter:

< 30.1 µm

Geometric standard deviation:

ca. 0.75

Key result

Percentile:

D10

Mean:

< 9.5 µm

St. dev.:

0.081

Key result

Percentile:

D50

Mean:

< 30.1 µm

St. dev.:

0.75

Key result

Percentile:

D90

Mean:

< 69.4 µm

St. dev.:

4.393

The individual measurements and the results obtained using the laser diffraction of BLUE GS 5664.80 are summarised in Table 1 and Table 2. The tables represent rounded results obtained by using the exact measurement data.

 

Table 1: Particle size distribution of BLUE GS 5664.80

%	1. Run Particle Size µm	2. Run Particle Size µm	3. Run Particle Size µm	4. Run Particle Size µm	Mean Particle Size µm	Stand. Dev. [±]
5	<9.56	<9.65	<9.51	<9.46	<9.5	0.081
10	<12.67	<12.78	<12.62	<12.54	<12.7	0.100
50	<31.06	<30.23	<29.63	<29.37	<30.1	0.750
90	<75.17	<69.53	<68.24	<64.58	<69.4	4.393

* The MMD of the test item indicates that 50 % of the particles are smaller than 30.1 µm.

 

Table 2: Particle size distribution of BLUE GS 5664.80 (% at the relevant particle size)

 

%	1. Run %	2. Run %	3. Run %	4. Run %	Mean %	Stand. Dev. [±]
<0.3	-	-	-	-
<0.5	0.00	0.00	0.00	0.00	0.00	0.00
<1.0	0.01	0.01	0.01	0.01	0.01	0.00
<2.0	0.13	0.15	0.15	0.14	0.14	0.01
<3.0	0.32	0.35	0.37	0.38	0.36	0.03
<4.0	0.57	0.60	0.66	0.68	0.63	0.05
<5.0	0.94	0.96	1.05	1.08	1.01	0.07
<6.0	1.47	1.47	1.59	1.62	1.54	0.08
<7.0	2.20	2.18	2.31	2.35	2.26	0.08
<8.0	3.13	3.07	3.23	3.27	3.18	0.09
<9.0	4.26	4.17	4.34	4.40	4.29	0.10
<10.0	5.60	5.47	5.66	5.74	5.62	0.11
<20.0	25.96	26.17	26.90	27.25	26.57	0.61
<30.0	47.91	49.51	50.81	51.37	49.90	1.54
<40.0	64.23	66.81	68.15	69.07	67.07	2.11
<50.0	75.24	78.07	79.13	80.44	78.22	2.21
<60.0	82.77	85.43	86.16	87.73	85.52	2.07
<70.0	87.87	90.17	90.61	92.28	90.23	1.82
<80.0	91.50	93.41	93.65	95.26	93.46	1.54
<90.0	94.06	95.61	65.71	97.19	95.64	1.28
<100.0	95.86	97.10	97.12	98.41	97.12	1.04
<125.0	98.39	99.05	98.99	99.81	99.06	0.58
<150.0	99.49	99.81	99.74	100.0	99.76	0.21
<175.0	99.92	100.0	99.98	100.0	99.98	0.04
<200.0	100.0	100.0	100.0	100.0	100.0	0.0
<225.0	100.0	100.0	100.0	100.0	100.0	0.0
<250.0	100.0	100.0	100.0	100.0	100.0	0.0
<275.0	100.0	100.0	100.0	100.0	100.0	0.0
<300.0	-	-	-	-

Conclusions:

Using a laser diffraction apparatus to study the particle size of BLUE GS 5664.80 in the range between 0.3 µm and 300 µm the mass median diameter (MMD) was determined to be 30.1 µm. The particle size distribution was found to range from approximately 1.0 µm to 175 µm.

Executive summary:

The determination of the particle size distribution of BLUE GS 5664.80 was performed according to the European Commission, Document ECB/TM/February 1996: "Particle Size Distribution, Fibre Length and Diameter Distribution" Guidance Document using the laser diffraction method.

BLUE GS 5664.80 is a dark-blue to black powder. Under the microscope (with a magnification of 400) dark-blue to black, round, crystalline structures were observed.

A solubility test showed, that the test item is both sparingly soluble and well dispersible in petroleum benzine containing Sympatens SH0/400. For the particle size distribution measurement BLUE GS 5664.80 was dispersed two times and each dispersion was measured in duplicate.

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

ln conclusion using a laser diffraction apparatus to study the particle size of BLUE GS 5664.80 in the range between 0.3 µm and 300 µm the mass median diameter (MMD) was determined to be 30.1 µm. The particle size distribution was found to range from approximately 1.0 µm to 175 µm.

Description of key information

Using a laser diffraction apparatus to study the particle size of BLUE GS 5664.80 in the range between 0.3 µm and 300 µm the mass median diameter (MMD) was determined to be 30.1 µrm. The particle size distribution was found to range from approximately 1.0 µm to 175 µm.