trisodium 3-[(E)-2-(4-{[4-chloro-6-({2-[(4-{[4-(ethenesulfonyl)phenyl]amino}-6-fluoro-1,3,5-triazin-2-yl)amino]propyl}amino)-1,3,5-triazin-2-yl]amino}-5-sulfonaphthalen-1-yl)diazen-1-yl]naphthalene-1,5-disulfonate

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:

10 August 2006 to 11 September 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: EC, 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:

not specified

Qualifier:

according to guideline

Guideline:

other: EC, 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 "Particle Size Distribution, Fibre Length and Diameter Distribution" Draft Guidance Document, EUR 20268 EN(2002), Part 5.2 "Laser scattering/diffraction"

GLP compliance:

yes (incl. QA statement)

Remarks:

RCC Ltd., CH-4452 Itingen, Switzerland

Type of method:

Laser scattering/diffraction

Type of distribution:

other: laser scattering/diffraction

Specific details on test material used for the study:

Identity: FAT 40826/A
Batch: TZ 5604 BOP 01/06
Purity: Content of organic part (Na-salt): approx. 78 %
Oligomers: 13 %
Main component: approx. 48 %
Appearance: Solid, orange powder
Expiration date: February 01, 2011
Storage: At room temperature at about 20 °C in a desiccator.

Mass median aerodynamic diameter:

5.1 µm

Percentile:

D50

Mean:

5.1 µm

Remarks on result:

other: No source field for Standard deviation.

Percentile:

D10

Mean:

< 1.4 µm

St. dev.:

0.013

Percentile:

D50

Mean:

< 5.1 µm

St. dev.:

0.122

Percentile:

D90

Mean:

< 11 µm

St. dev.:

0.259

Conclusions:

The mass median (aerodynamic) diameter of FAT 40826/A is 5.1 µm. The particle size distribution was found to range from approximately 0.3 µm to 18 µm.

Executive summary:

In a GLP-compliant study, using the laser scattering/diffraction method, the mass median diameter of FAT 40826/A 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 40826/A is a fine orange powder. Under the microscope (with a magnification of 400) orange globules of different sizes 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 FAT 40826/A was performed with two samples of the stock dispersion each 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. In conclusion, using the laser diffraction method to study the particle size of FAT 40826/A ranging between 0.3 µm and 300 µm, the mass median diameter (MMD) was determined to be 5.1 µm. The particle size distribution was found to range from approximately 0.3 µm to 18.0 µm. This value is also taken forward to represent the Mass Median Aerodynamic Diameter (MMAD).

Description of key information

The mass median diameter of the test substance is 5.1 µm. The particle size distribution was found to range from approximately 0.3 µm to 18 µm.

Additional information

In a GLP-compliant study, using the laser scattering/diffraction method, the mass median diameter of FAT 40826/A 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 40826/A is a fine orange powder. Under the microscope (with a magnification of 400) orange globules of different sizes 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 FAT 40826/A was performed with two samples of the stock dispersion each 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. In conclusion, using the laser diffraction method to study the particle size of FAT 40826/A ranging between 0.3 µm and 300 µm, the mass median diameter (MMD) was determined to be 5.1 µm. The particle size distribution was found to range from approximately 0.3 µm to 18.0 µm. This value is also taken forward to represent the mass median aerodynamic diameter (MMAD).