Trisodium 1-amino-4-[[3-[[4-chloro-6-[(sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

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:

2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’, 2002.

GLP compliance:

yes

Type of method:

cascade impaction

Type of distribution:

volumetric distribution

Specific details on test material used for the study:

Identification: FAT 41001/H TE
Physical State/Appearance: Dark blue Solid
Chemical Name: Trisodium 1-amino-4-[[3-[[4-chloro-6-[(sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-
dioxoanthracene-2-sulphonate
Commercial Name: Reactive Blue 049
EC No: 276-481-8
CAS No: 72214-18-7
Batch: BOP 01-12 (Lot: BS-1106872)
Purity: 77.3 %
Expiry: 31 January 2017
Storage Conditions: Frozen in the dark

Percentile:

D50

Remarks on result:

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

No.:

#1

Size:

< 100 µm

Distribution:

98.5 %

No.:

#2

Size:

< 10 µm

Distribution:

0.08 %

Remarks on result:

other: Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter.

No.:

#3

Size:

< 5.5 µm

Distribution:

0.06 %

Sieve Screening Test

The results of the sieving procedure are shown in the following table:

 

Measurement	Result
Mass of test item transferred to sieve	10.03g
Mass of test item passed through sieve	9.88 g
Percentage of test item less than 100 µm	98.5 %

Cascade impactor:

Mean cumulative percentage with a particle size less than 10.0 μm : 0.08%

Mean cumulative percentage with a particle size less than 5.5 μm : 0.06%

Conclusions:

The percentage of FAT 41001/H having an inhalable particle size of less than 100 µm was determined to be 98.5%. The test item has been considered to be essentially inhalable.

Executive summary:

Particle Size Distribution and Hydrolysis as a function of pH of FAT 41001/H TE was determined according European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’, 2002. Based on the findings of the study; the proportion of FAT 41001/H having an inhalable particle size of less than 100 µm was determined by a sieve method to be 98.5 %. The proportion of FAT 41001/H having an thoracic particle size of less than 10 µm was determined by Cascade impactor method to be 0.08 % and the proportion of FAT 41001/H having an respirable particle size of less than 5.5 µm was determined by a Cascade impactor method to be 0.06 %. The test item has been considered to be essentially inhalable.

Description of key information

Based on the findings of the study; the proportion of FAT 41001/H having an inhalable particle size of less than 100 µm was determined by a sieve method to be 98.5%. The proportion of FAT 41001/H having a thoracic particle size of less than 10 µm was determined by Cascade impactor method to be 0.08 % and the proportion of FAT 41001/H having an respirable particle size of less than 5.5 µm was determined by a Cascade impactor method to be 0.06 %. The test item has been considered to be essentially inhalable.