Disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)

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).

Deviations:

no

GLP compliance:

no

Type of method:

cascade impaction

Type of distribution:

mass based distribution

Specific details on test material used for the study:

Identification: FAT 20011/E TE
Physical State/Appearance: Dark blue solid
CAS Name: Chromate(2-), (4-hydroxy-3-((2-hydroxy-4-nitrophenyl)azo)-1-naphthalenesulfonato(3-))(1-((2-hydroxy-4-nitrophenyl)azo)-2-naphthalenolato(2-))-, disodium
Commercial Name: Acid blue 317
EC No: 271-351-7
CAS No: 68541-71-9
Batch: 1309023 (China)
Purity: 61.2%
Expiry: 30 September 2018
Storage Conditions: Room temperature in the dark.

Percentile:

D50

Remarks on result:

other: Too few particles were of a size less than 10 µm to allow accurate assessment of the mass median aerodynamic diameter.

No.:

#1

Size:

< 100 µm

Distribution:

33.5 %

Remarks on result:

other: Sieve method

No.:

#2

Size:

< 10 µm

Distribution:

2.6 %

Remarks on result:

other: Cascade impactor

No.:

#3

Size:

< 5.5 µm

Distribution:

0.29 %

Remarks on result:

other: Cascade impactor

Sieve Screening Test Result:

Measurement	Result
Mass of test item transferred to sieve	18.00 g
Mass of test item passed through sieve	6.03 g
Percentage of test item less than 100 µm	33.5%

Cascade Impactor:

The results of the cascade impactor procedure are shown in the following table:

Collection Stage	Particle Size Range Collected (µm)	Collected Mass (g)
		Determination 1	Determination 2	Determination 3
Artificial throat	n/a	0.12	0.12	0.09
Cup 1	>10.0	2.7775	2.7101	2.8030
Cup 2	5.5 to 10.0	0.0702	0.0728	0.0610
Cup 3	2.4 to 5.5	0.0075	0.0081	0.0000
Cup 4	1.61 to 2.4	0.0003	0.0007	0.0006
Cup 5	0.307 to 1.61	0.0000	0.0000	0.0000
Final Filter	< 0.307	0.0023	0.0035	0.0030
Total mass of collected test item		2.9778	2.9152	2.9576
Mass of test item added		3.0841	3.0181	3.0512

The cumulative amounts of test item collected in the three determinations for the individual particle size cut-points are shown in the following table:

Particle Size Cut Points (µm)	Cumulative Mass (g)			Cumulative Percentage (%)
	Determination 1	Determination 2	Determination 3	Determination 1	Determination 2	Determination 3
<10.0	0.0803	0.0851	0.0646	2.70	2.92	2.18
<5.5	0.0101	0.0123	0.0036	0.34	0.42	0.12
<2.4	0.0026	0.0042	0.0036	0.09	0.14	0.12
<1.61	0.0023	0.0035	0.0030	0.08	0.12	0.10
<0.307	0.0023	0.0035	0.0030	0.08	0.12	0.10

Conclusions:

Percentage of test item with an inhalable particle size <100 µm (Sieve method): 33.5 %
Percentage of test item with a thoracic particle size <10.0 µm (Cascade Impactor): 2.60 %
Percentage of test item with a respirable particle size <5.5 µm (Cascade Impactor): 0.29 %

Executive summary:

The particle size distribution and hydrolysis as a function of pH of FAT 20011/E TE have been determined using a procedure designed to be compatible with the European Commission Technical ‘Guidance Document EUR 20268 Determination of Particle Size Distribution, Fiber Length and Diameter Distribution of Chemical Substances’ (2002).

 

Screening test was conducted using Sieving apparatus (100 µm stainless steel mesh). For main test, Cascade impactor was used (size; nominally 0.3 to 10 µm).

 

Based on findings of the study, the particular size distribution is determined as below:

Percentage of test item with an inhalable particle size <100 µm (Sieve method): 33.5 %

Percentage of test item with a thoracic particle size <10.0 µm (Cascade Impactor): 2.60 %

Percentage of test item with a respirable particle size <5.5 µm (Cascade Impactor): 0.29 %

Description of key information

The particle size distribution of the test item has been determined using a procedure designed to be compatible with the European Commission Technical ‘Guidance Document EUR 20268 Determination of Particle Size Distribution, Fiber Length and Diameter Distribution of Chemical Substances’ (2002). A screening test was conducted using Sieving apparatus (100 µm stainless steel mesh). For main test, Cascade impactor was used (size; nominally 0.3 to 10 µm).

 

Based on findings of the study, the particular size distribution is determined as below:

Percentage of test item with an inhalable particle size <100 µm (Sieve method): 33.5 %

Percentage of test item with a thoracic particle size <10.0 µm (Cascade Impactor): 2.60 %

Percentage of test item with a respirable particle size <5.5 µm (Cascade Impactor): 0.29 %