3-(benzothiazol-2-yl)-7-(diethylamino)-2-oxo-2H-1-benzopyran-4-carbonitrile

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions) - Method B: Fibre Length and Diameter Distributions

Principles of method if other than guideline:

In considersation of the relevance of granulometry on toxicological assessment, only the size distribution of the sieved fraction <100 µm were studied in detail.

GLP compliance:

yes (incl. QA statement)

Type of method:

sieving

Type of distribution:

mass based distribution

Mass median aerodynamic diameter:

15.41 µm

Percentile:

D50

Mean:

15.41 µm

Remarks on result:

other: spherical volume

No.:

#1

Size:

< 4 µm

Distribution:

0.21 %

Remarks on result:

other: spherical volume

No.:

#2

Size:

>= 4 - < 10 µm

Distribution:

14.58 %

Remarks on result:

other: spherical volume

No.:

#3

Size:

>= 10 - <= 100 µm

Distribution:

85.22 %

Remarks on result:

other: spherical volume

Sieve Fraction:

- weighted sample: 0.4472 g

- weight fraction <100 μm: 0.003 g

- sieve mass fraction <100 μm: 0.67 %

The mass fraction <100 µm was 0.67 %, and was investigated by scanning electron microscopy. The mean diameter (median) was 8.3 µm with 4.39 µm standard deviation. The median aspect ratio (median) was 1.78 with 0.61 as standard deviation.

The median diameter (mass fraction) of the particle size is given for the fraction <100 µm. The value 15.41 µm was calculated for spherical and the value 7.77 µm was calculated for cubical particles.

Particle Size	Spherical Volume	Cubical Volume
< 4 µm (respirable)	0.21 %	7.20 %
4 - 10 µm (thoracic)	14.58 %	60.50 %
10 - 100 µm (inhalable)	85.22 %	32.29 %
> 100 µm	0 %	0 %
Median (diameter)	15.41 µm	7.77 µm

Conclusions:

For Macrolex Fluoreszenzrot G the MMAD (Mass Median Aerodynamic Diameter) < 100 µm has a value of 15.41 µm as spherical particles.

Executive summary:

According to OECD Guideline No. 110 Method B the particle size distribution of Macrolex Fluoreszenzrot G was determined by scanning electron microscopy after the samples was fractionated by a 100 μm sieve (0.67 % of total sample) and presented on the basis of calculated mass fractions.

The mean diameter (median) was 8.3 µm with 4.39 µm standard deviation. The median aspect ratio was 1.78 µm with a standard deviation of 0.61 µm. The median diameter (mass fraction ) of the particle size is given for the fraction < 100 µm. For spherical particles a MMAD (Mass Median Aerodynamic Diameter) of 15.41 µm was determined. Thus, the tested particles with sieved size smaller than 100 µm are mainly dominated by inhalable fraction.

Description of key information

According to OECD Guidelen No. 110 Method B the particle size distribution of Macrolex Fluoreszenzrot G was determined by scanning electron microscopy after the samples was fractionated by a 100 μm sieve (0.67 % of total sample) and presented on the basis of calculated mass fractions.

For spherical particles a MMAD (Mass Median Aerodynamic Diameter) of 15.41 µm was determined. The main fraction of 85.22 % spherical volume particles distributing in the range of 10 - 100 µm. Thus, the tested particles with sieved size smaller than 100 µm are mainly dominated by inhalable fraction.