13-β-ethyl-3-methoxygona-2,5(10)-dien-17-one

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:

27.25 µm

Percentile:

D50

Mean:

27.25 µm

Remarks on result:

other: spherical volume

No.:

#1

Size:

3 - 5 µm

Distribution:

1.17 %

Remarks on result:

other: of the sieve fraction < 100 µm

No.:

#2

Size:

5 - 100 µm

Distribution:

98.83 %

Remarks on result:

other: of the sieve fraction < 100 µm

Result: Sieve Fraction (<100µm):

- weighted sample: 0.8697 g

- weight fraction <100µm: 0.6388 g

- mass fraction <100µm: 73.45 %

The mass fraction <100µm was 73.45 %, and was investigated by scanning electron microscopy. The mean diameter (median) was 26.14µm with 11.24µm standard deviation. The median aspect ratio (median) was 1.59 with 0.44 as standard deviation.

The median diameter (mass fraction) of the particle size is given for the fraction <100µm. The value 27.25µm was calculated for spherical and the value 26.98µm was calculated for cubical particles.

Particle Size  Spherical Volume [%]  Cubical Volume [%]  <4 µm (respirable)  0.00  0.00  4-10 µm (thoracic)  0.05  0.07  10-100 µm (inhalable)  99.95  99.93  >100 µm  0.00 0.00   Median (diameter µm)  27.25  26.98

Conclusions:

The MMAD (Mass Median Aerodynamic Diameter < 100 µm) has a value fof 27.25 µm as spherical particles.

Executive summary:

According to OECD guideline 110 the particle size distribution of D-ET-DIENON was determined by scanning electron microscopy method for the sieved fraction (< 100 µm, 73.45 % of total sample) and presented on the basis of calculated mass fractions. The median diameter was

27.25 µm with the main fraction of 73.41 % distributing in the range of 4-100 µm and hence the tested particles with sieved size smaller than 100 µm are mainly dominated by inhalable fraction as defined in EU 481.

Description of key information

The MMAD (Mass Median Aerodynamic Diameter < 100 µm) of the substance has a value fof 27.25 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, 73.45 % of total sample) and presented on the basis of calculated mass fractions. The median diameter was 27.25 µm with the main fraction of 73.45 % distributing in the range of 4 -100 µm.