Imidazo[5,1-f][1,2,4]triazin-4(1H)-one, 2-[2-ethoxy-5-[(4-ethyl-1-piperazinyl)sulfonyl]phenyl]-5-methyl-7-propyl-

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:

2013

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)

Version / remarks:

(method B)

Deviations:

no

GLP compliance:

no

Type of method:

other: Sieving followed by electron microscopy.

Type of distribution:

counted distribution

Mass median aerodynamic diameter:

66.5 µm

Percentile:

D50

Remarks on result:

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

The sample was first sieved by a 100 µm sieve.

weighted sample: 1.3414 g

weight fraction < 100 µm: 0.2856 g

mass fraction < 100 µm: 21.29 %

Result: Particle Size Distribution of the sieve fraction nominal < 100 µm

10.16 %: 2 - 3 µm

29.30 %: 3 - 5 µm

60.54 %: 5 - 100 µm

statistical data:

Counts	1191
	Mean diameter [¿m]	Aspect Ratio
Minimum	2.36	1.00
Maximum	99.92	11.67
Arithmetic mean	13.42	1.79
Median	6.19	1.67
Standard deviation	16.71	0.63

Result: Mass Fraction (calculated) of the sieve fraction nominal < 100 µm:

Particle size	spherical volume [%]	cubical volume [%]
< 4 µm (respirable)	0.04	0.07
4 - 10 µm (thoracic)	0.44	0.65
10 - 100 µm (inhalable)	99.52	99.28
> 100 µm	0.00	0.00
Median (diameter µm)	66.50	62.32

Median diameter corresponds to MMAD (Mass Median Aerodynamic Diameter).

Conclusion:

Accounting based on the total sample weight
	Particle Size [¿m]	Spherical Volume [%]
Mass Fraction	>100	78.71
Sieve Fraction	>100	0.00
Total (>100¿m)		78.71
Sieve Fraction	10-100 (inhalable)	21.19
Sieve Fraction	4-10 (thoracic)	0.09
Sieve Fraction	<4 (respirable)	0.01

Conclusions:

The MMAD (Mass Median Aerodynamic Diameter < 100 µm) has a value of 66.5 µm as spherical particles.

Executive summary:

According to OECD guideline 110, the particle size distribution of the substance was determined by scanning electron microscopy method for the sieved fraction (< 100 µm, 21.29 % of total sample) and presented on the basis of calculated mass fractions. The median diameter was 66.5 µm with the main fraction of 99.52 % distribution in the rang of 10 - 100 µm; and hence the tested substance particles with sieved size smaller than 100 µm are mainly dominated by inhalable fraction as defined in EN 481.

Description of key information

The MMAD (Mass Median Aerodynamic Diameter < 100¿m) has a value of 66.5 ¿m as spherical particles.