Tetrasodium 2,2''-diamino-8,8''-dihydroxy-4',4'''-{4-[bis(2-hydroxyethyl)amino]-1,3,5-triazine-2,6-diyldiimino}bis(naphthalene-1-azobenzene-2',6-disulfonate)

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 19th to 21st, 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Particle size distribution, fibre length and diameter distribution, Guidance document, ECB/TM/February 1996

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of particle tested:

primary particle

Type of distribution:

volumetric distribution

Test material

Test material information

Constituent 1

Reference substance name:

Red LF 6339

IUPAC Name:

Red LF 6339

Results and discussion

Mass median aerodynamic diameter:

4 µm

Particle size

Percentile:

D50

Mean:

4 µm

St. dev.:

0.619

Any other information on results incl. tables

Particle Size Distribution:
< 0.5 µm :  2.72%
< 1.0 µm :  10.12%
< 2.0 µm :  25.06%
< 3.0 µm :  38.20%
< 4.0 µm :  49.88%
< 5.0 µm :  60.24%
< 6.0 µm :  69.16%
< 7.0 µm :  76.52%
< 8.0 µm :  82.5%
< 10.0 µm :  90.79%
< 20.0 µm :  100%
< 30.0 µm :  100%

Mass Median Diameter:
MMD = 4.0 µm

Applicant's summary and conclusion

Conclusions:

MMD = 4.0 µm

Executive summary:

The particle size distribution is evaluated according to the Guidance document, ECB/TM/February 1996.

The Mass Median Diameter was found to be 4.0 µm