N,N-bis(2-hydroxypropyl)benzamide

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:

From July 4th to July 11th, 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: European Commission, Document ECB/TM/February 1996: "Particle size distribution, fibre lenght and diameter distribution" Guidance Document

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of particle tested:

primary particle

Type of distribution:

mass based distribution

Specific details on test material used for the study:

- Name of test material (as cited in study report): PRIMID V 40-32
- Physical state: Solid
- Analytical purity: 96%
- Lot/batch No.: HSH 0015.1
- Expiration date of the lot/batch: March 31, 2003
- Storage condition of test material: At room temperature at about 20 °C
- Stability: Stable under storage conditions

Mass median aerodynamic diameter:

30.4 µm

Geometric standard deviation:

0.529

Key result

Percentile:

D50

Mean:

< 30.4 µm

St. dev.:

0.529

Percentile:

D10

Mean:

< 17.4 µm

St. dev.:

0.784

Percentile:

D90

Mean:

< 68.3 µm

St. dev.:

9.829

No.:

#1

Size:

ca. 0.5 - ca. 275 µm

Distribution:

ca. 100 %

Substance is a white powder. Under the microscope (with a magnification of 400) colourless, four-cornered crystalline structures in different sizes were observed.

The solubility test showed that the test item is both sparingly soluble and well dispersible in petroleum benzine.

The particle size distribution was found in the range from approximately 0.5 to 275 μm.

Conclusions:

Using a laser diffraction apparatus to study the particle size of the substance in the range between 0.3 and 300 μm, the mass median diameter (MMD) was determined to be 30.4 μm. The particle size distribution was found to range approximately from 0.5 μm to 275 μm.

Executive summary:

The determination of particle size distribution was performed according to the European Commission, Document ECB/TM/February 1996: "Particle size distribution, fibre lenght and diameter distribution", using the laser diffraction method.

Substance is a white powder. Under the microscope (with a magnification of 400) colourless, four-cornered crystalline structures in different sizes were observed.

A solubility test showed that the test item is both sparingly soluble and well dispersible in petroleum benzine.

For the particle size distribution measurement, the substance was dispersed four times in pre-saturated petroleum benzine.

Using a laser diffraction apparatus in the range between 0.3 and 300 μm, the mass median diameter (MMD) was determined to be 30.4 μm. The particle size distribution was found to range approximately from 0.5 μm to 275 μm.

The results obtained during the measurements showed no relevant differences. Therefore the study is considered to be valid and no further testing is necessary.

Description of key information

In a study according to the Guidance Document ECB/TM/1996, the mass median diameter (MMD) was determined to be 30.4 μm.

Additional information

The particle size distribution was found to range approximately from 0.5 μm to 275 μm.