5-(Acetyl-(3-(acetyl-(3,5-bis(2,3-dihydroxypropylcarbamoyl)-2,4,6-triiodophenyl)amino)-2- hydroxypropyl)amino)-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide; 5,5'-((2-Hydroxytrimethylene)bis(acetylimino))bis(N,N'-bis(2,3-dihydroxypropyl)-2,4,6- triiodoisophthalamide);

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

25.09.2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study meets the requirements of the OECD Principles of Good Laboratory Practice, Paris, 1992.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Materials and methods

Test guideline

Guideline:

other: CTL SOP 224

Principles of method if other than guideline:

To determine the particle size by mechanical sieving.Apparatus: Endecotts Octagon sieve shaker and 8" diamater sieves to BS 410.

GLP compliance:

yes

Type of distribution:

other: Cumulative distribution (% by weight)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Results and discussion

Particle size

Percentile:

D50

Mean:

> 300 µm

Remarks on result:

other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.

Particle size distribution at different passages

Particle size distribution at different passages 1

No.:

#1

Size:

< 53 µm

Distribution:

0 %

Particle size distribution at different passages 2

No.:

#2

Size:

< 63 µm

Distribution:

0 %

Particle size distribution at different passages 3

No.:

#3

Size:

< 75 µm

Distribution:

0 %

Particle size distribution at different passages 4

No.:

#4

Size:

< 90 µm

Distribution:

4.6 %

Particle size distribution at different passages 5

No.:

#5

Size:

< 106 µm

Distribution:

8 %

Particle size distribution at different passages 6

No.:

#6

Size:

< 150 µm

Distribution:

17.2 %

Particle size distribution at different passages 7

No.:

#7

Size:

< 300 µm

Distribution:

48.6 %

Any other information on results incl. tables

Agglomeration observed in most sieves, therefore the sample is believed to be finner than the test indicates (due to observed blinding/agglomeration effects).