2-[bis(2-hydroxyethyl)amino]-2-(hydroxymethyl)-1,3-propanediol hydrochloride

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:

2020-06-16 to 2020-07-09

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 A: Particle Size Distribution (effective hydrodynamic radius)

Version / remarks:

1981

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 830.7520 (Particle Size, Fiber Length, and Diameter Distribution)

Version / remarks:

1996

Deviations:

no

Qualifier:

according to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Version / remarks:

2009

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of particle tested:

other: ground test item

Type of distribution:

volumetric distribution

Key result

Percentile:

D50

Mean:

463.7 µm

St. dev.:

24

Percentile:

D10

Mean:

37.6 µm

St. dev.:

4.1

Percentile:

D90

Mean:

1 031.7 µm

St. dev.:

10

Test series 1:

D₁₀:      41.7 µm                                                        Standard deviation: 1.2 µm

D₅₀:      487.6 µm       (Median diameter)                Standard deviation: 11.0 µm

D₉₀:      1041.7 µm                                                  Standard deviation: 14.3 µm

 

Test series 2:

D₁₀:      33.5 µm                                                        Standard deviation: 1.2 µm

D₅₀:      439.7 µm       (Median diameter)                Standard deviation: 3.4 µm

D₉₀:      1021.6 µm                                                  Standard deviation: 11.9 µm

 

Average:

D₁₀:      37.6 µm                                                        Standard deviation: 4.1 µm

D₅₀:      463.7 µm       (Median diameter)                Standard deviation: 24.0 µm

D₉₀:      1031.7 µm                                                  Standard deviation: 10.0 µm

Conclusions:

The ground test item was determined to have a median particle size D50 = 463.7 µm, using laser diffraction measurement according to OECD Test Guideline 110.

Executive summary:

The particle size distribution of the test item was determined using laser diffraction measurement according to OECD Test Guideline 110. As the test item generally agglomerates and was mostly present as a solid block inside its container, the necessary amount was broken off the block and carefully ground using a mortar and pestle. Since much force had to be used during the process, the stated particle sizes should be used witch caution as the particle sizes due to grounding are smaller than for the non-treated substance. Two series with ground test item were conducted to determine an average value. For the ground test item the average median particle size was determined to be D₅₀ = 463.7 µm. The average D₁₀  was determined as 37.6 µm and the D₉₀ was 1031.7 µm.

Description of key information

The ground test item was determined to have a median particle size D50 = 463.7 µm, using laser diffraction measurement according to OECD Test Guideline 110 (reference 4.5 -1).

Additional information

The particle size distribution of the test item was determined using laser diffraction measurement according to OECD Test Guideline 110. As the test item generally agglomerates and was mostly present as a solid block inside its container, the necessary amount was broken off the block and carefully ground using a mortar and pestle. Since much force had to be used during the process, the stated particle sizes should be used witch caution as the particle sizes due to grounding are smaller than for the non-treated substance. Two series with ground test item were conducted to determine an average value. For the ground test item the average median particle size was determined to be D₅₀ = 463.7 µm. The average D₁₀ was determined as 37.6 µm and the D₉₀was 1031.7 µm.