19-Norpregn-5(10)-ene-21-nitrile, 17-hydroxy-3-oxo-, (17.alpha.)-

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

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:

no

Type of method:

determination of fibre length and diameter distributions

Type of distribution:

counted distribution

Mass median aerodynamic diameter:

55.93 µm

Percentile:

D50

Mean:

55.93 µm

Remarks on result:

other: spherical volume(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)

No.:

#1

Size:

3 - 5 µm

Distribution:

0 %

No.:

#2

Size:

5 - 100 µm

Distribution:

96.78 %

No.:

#3

Size:

> 100 µm

Distribution:

3.22 %

Result: Sieve Fraction (<100µm):

- weighted sample: 1.0391 g

- weight fraction <100µm: 0.1479 g

- mass fraction <100µm: 14.23 %

The mass fraction <100 µm was 14.23 %, and was investigated by scanning electron microscopy. The mean diameter (median) was 41.56 µm with 23.83 µm standard deviation. The median aspect ratio (median) was 1.55 with 0.45 as standard deviation.

The median diameter (mass fraction) of the particle size is given for the fraction <100 µm. The value 55.93 µm was calculated for spherical and the value 50.62 µm was calculated for cubical particles.

Particle Size  Spherical Volume [%]  Cubical Volume [%]  <4 µm (respirable)  0.00 0.00  4-10 µm (thoracic)  0.00 0.00  10-100 µm (inhalable)  74.05  76.53  >100 µm 25.95 23.47  Median (diameter µm) 55.93 50.62

Conclusions:

The MMAD (Mass Median Aerodynamic Diameter < 100µm) has a value of 55.93 µm as spherical particles.

Executive summary:

According to OECD guideline 110 the particle size distribution of 5-Dehydrocyanomethylketon was determined by scanning electron microscopy method for the sieved fraction (<100µm was 14.23 % of the total sample) and presented on the basis of calculated mass fractions.

The mean diameter (median) was 41.56 µm with 23.83 µm standard deviation. The median aspect ratio (median) was 1.55 with 0.45 as standard deviation. The median diameter (mass fraction) of the particle size is given for the fraction <100µm. The value 55.93 µm was calculated for spherical particles and hence the tested particles with sieved size smaller than 100 µm are mainly dominated by inhalable fraction as defined in EU 481.

Description of key information

The MMAD (Mass Median Aerodynamic Diameter < 100 µm) has a value of 55.93 µm as spherical particles.

Additional information

According to OECD guideline 110 the particle size distribution was determined by scanning electron microscopy method for the sieved fraction (< 100 µm, 14.23 % of total sample) and presented on the basis of calculated mass fractions. The median diameter was 55.93 µm with the main fraction of 10.54 % spherical volume distributing in the range of 10 -100 µm and hence the tested particles with sieved size smaller than 100 µm are mainly dominated by inhalable fraction as defined in EU 481.