N-[3-(dimethylamino)propyl]stearamide monoacetate

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:

2015-02-05 to 2015-06-02

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

OECD Method 110

Qualifier:

according to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)

GLP compliance:

yes (incl. QA statement)

Remarks:

The UK Good Laboratory Practice Regulations (Statutory Instrument 1999 No. 3106, as amended by Statutory Instrument 2004 No. 994). EC Commission Directive 2004/10/EC of 11 February 2004. OECD Principles of Good Laboratory Practice, ENV/MC/CHEM(98)17.

Type of method:

Laser scattering/diffraction

Remarks:

Pre-sieving was used to remove particles above 2 mm

Type of particle tested:

primary particle

Type of distribution:

counted distribution

Key result

Percentile:

D10

Mean:

330 µm

Remarks on result:

other: Standard deviation not obtained

Key result

Percentile:

D50

Mean:

830 µm

Remarks on result:

other: Standard deviation not obtained

Key result

Percentile:

D90

Mean:

1 460 µm

Remarks on result:

other: Standard deviation not obtained

The following parameters are calculated automatically by the instrument software:
d10, or d(0.1), is the diameter where 90% of the distribution is above and 10% is below.
d50, or d(0.5) is the diameter where 50% of the distribution is above and 50% is below, also known as the Mass Median Diameter (MMD).
d90, or d(0.9) is the diameter where 10% of the distribution is above and 90% is below.

 

N.B. Approximately 50% by weight of the test substance had a particle size greater than 2 mm (pre-sieving).

Conclusions:

Approximately 50% by weight of the test substance had a particle size greater than 2 mm (pre-sieving).
Of the sieved fraction, substance was determined to have d10, d50 and d90 values of 330, 830 and 1460 μm respectively, with a negligible quantity of material smaller than 100 μm.

Executive summary:

A study was performed to determine the particle size distribution of the substance. The study was designed in accordance with accepted principles in order to meet the requirements of REACH Regulation (EU) No 1907/2006 of the European Parliament and of the Council.

The method followed is amongst those described in the OECD Guidelines for the Testing of Chemicals (Method 110).

The substance was pre-sieved to remove material of particle size greater than 2 mm. This equated to approximately 50% by weight of the test substance.

Of the sieved fraction, the substance was determined to have d(0.1), d(0.5) and d(0.9) values of 330, 830 and 1460 μm respectively, with a negligible quantity of material smaller than 100 μm.

Description of key information

Approximately 50% by weight of the test substance had a particle size greater than 2 mm (pre-sieving).
Of the sieved fraction, substance was determined to have d10, d50 and d90 values of 330, 830 and 1460 μm respectively, with a negligible quantity of material smaller than 100 μm.