5,5'-diisopropyl-2,2'-dimethylbiphenyl-4,4'-diyl dihypoiodite

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:

25 June 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Qualifier:

according to guideline

Guideline:

other: Chilworth Technology Limited Standard Operating Procedures (CTL SOP No. 417)

Deviations:

no

Qualifier:

according to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187 “Particle Size Analysis by Laser Diffraction”, Handbook K

Version / remarks:

2007

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Remarks:

and optical microscope analysis

Type of particle tested:

primary particle

Type of distribution:

volumetric distribution

Mass median aerodynamic diameter:

166 µm

Geometric standard deviation:

0.03

Percentile:

D10

Mean:

3.95 µm

St. dev.:

0.072

Percentile:

D50

Mean:

129 µm

St. dev.:

2.26

Percentile:

D90

Mean:

373 µm

St. dev.:

8.9

Optical Microscope Analysis

- Standard visual observation: Sample observed to be a fine to medium, yellowish powder with clusters.

- Observation using 3.2 objective lens: The particles appeared to be irregular shaped crystals. The smallest individual particle size was approximately 3 μm and the largest individual size was approximately 96 μm.

- Observation using 40 objective lens: The sample was observed to be made up of agglomerated, crystalline particles.

Solubility and Dispersability Test

Solvent used	Soluble	Comments
Water	No	Floats on surface
2 -propanol	Yes	Soluble
Methanol	No	Well dispersed

The sample was well dispersed in two of the three solvents tested. For the full solubility and dispersability test methanol and water were selected.

In the full solubility test the sample proved to be insoluble and well dispersed in both methanol and water. Both solvents were therefore trialled as the dispersant.

Laser Diffraction

The coefficient of variation for d50 was less than 3 %; d10 and d90 are less than 5 %. Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.

Conclusions:

Under the conditions of the study the MMAD was determined to be 166 µm while the D10, D50 and D90 were determined to be 3.95, 129 and 373 µm, respectively. 16.57 % of the particles were < 10 µm.

Executive summary:

A particle size analysis of the substance was conducted under GLP conditions and in accordance with the Standard Operating Procedures of the test laboratory and in accordance with ISO 13320:2009 “Particle Size Analysis – Laser Diffraction Methods”, 2009 and CIPAC MT 187 “Particle Size Analysis by Laser Diffraction”, Handbook K, 2007.

Under the conditions of the study the MMAD was determined to be 166 µm while the D10, D50 and D90 were determined to be 3.95, 129 and 373 µm, respectively. 16.57 % of the particles were < 10 µm.

Description of key information

Under the conditions of the study the MMAD was determined to be 166 µm while the D10, D50 and D90 were determined to be 3.95, 129 and 373 µm, respectively. 16.57 % of the particles were < 10 µm.

Additional information

A particle size analysis of the substance was conducted under GLP conditions and in accordance with the Standard Operating Procedures of the test laboratory and in accordance with ISO 13320:2009 “Particle Size Analysis – Laser Diffraction Methods”, 2009 and CIPAC MT 187 “Particle Size Analysis by Laser Diffraction”, Handbook K, 2007. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

Under the conditions of the study the MMAD was determined to be 166 µm while the D10, D50 and D90 were determined to be 3.95, 129 and 373 µm, respectively. 16.57 % of the particles were < 10 µm.