Reaction mass of calcium dihydroxide and calcium peroxide

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:

06/07/2018 - 04/09/2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Version / remarks:

2009

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187

Version / remarks:

2007

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of particle tested:

primary particle

Type of distribution:

volumetric distribution

Mass median aerodynamic diameter:

7.97 µm

Geometric standard deviation:

4.198

Key result

Percentile:

D10

Mean:

< 1.05 µm

St. dev.:

0.001

Key result

Percentile:

D50

Mean:

< 4.52 µm

St. dev.:

0.015

Key result

Percentile:

D90

Mean:

< 39.4 µm

St. dev.:

0.221

No.:

#1

Size:

< 10 µm

Distribution:

62.72 %

Summary of results

Particle Size Analysis using small volume (wet) module (SVM)	Average (µm)
Volume weighted mean	13.5
Mode	2.56
d10 (10 % of material is <)	1.05
d50 (50 % of material is <) (median)	4.52
d90 (90 % of material is <)	39.1
MMAD (mass median aerodynamic diameter)	7.97
Volume of sample < 10.00 µm	62.72 %

 

Full test results

Run No.	1	2	3	4	5	Average*	STDVP	% STDVP
VWM	13.6	13.4	13.5	13.5	13.4	13.5	N/A	N/A
Mode	2.56	2.56	2.56	2.56	2.55	2.56	N/A	N/A
d10	1.05	1.05	1.05	1.05	1.05	1.05	0.00107	0.102
d50	4.53	4.50	4.53	4.53	4.50	4.52	0.0146	0.322
d90	39.5	39.0	39.1	39.0	38.9	39.1	0.221	0.565
MMAD	7.99	7.94	7.98	7.98	7.94	7.97	0.023	0.3
GSD	4.214	4.195	4.198	4.195	4.190	4.198	0.008	0.2

*calculated from the entirety of the data captured in each run and not a simple arithmetic mean.

GSD: geometric standard deviation of the lognormal particle size distribution; STDVP: standard deviation of the population; % STDVP: percentage standard deviation of the population.

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

Conclusions:

The key particle size distribution values for the test item are: D10 = 1.05 μm, D50 = 4.52 μm, D90 = 39.1 μm. 62.72% by volume of the sample was found to be < 10.00 µm. The MMAD of the sample is 7.97 µm.

Executive summary:

The particle size distribution of the test item was determined according to CIPAC MT 187 / ISO 13320 - Particle size analysis by laser diffraction (GLP study). The test item was observed to determine whether sieving of the material is required. Then, a method development for the particle size analysis on the material was undertaken to obtain the correct parameters for the formal analysis: microscopic observation to identify the most appropriate optical properties and solubility and dispersibility tests to determine the correct dispersant, dispersion pressures, and sample compatibility. Based on the results, 2-propanol was used as a dispersant and the tests were run in a small volume (wet) module (SVM). The test item was analyzed using a Laser Diffraction Analyser (the Malvern Mastersizer 3000). 5 runs were completed to ensure repeatability of results. The particle size distribution percentiles for the test item are: D10 = 1.05 μm, D50 = 4.52 μm, D90 = 39.1 μm. 62.72% by volume of the sample was found to be < 10.00 µm. The MMAD of the sample is 7.97 µm.

Description of key information

Key study. Method according to CIPAC MT 187 / ISO 13320, GLP study. The key particle size distribution percentiles for the test item are: D10 = 1.05 μm, D50 = 4.52 μm, D90 = 39.1 μm. 62.72% by volume of the sample was found to be < 10.00 µm. The MMAD of the sample is 7.97 µm.

Additional information

Key study. Determination of the particle size distribution of the test item according to CIPAC MT 187 / ISO 13320, GLP study. Based on the parameters obtained in a preliminary method development, the particle size distribution of the test item was analysed with a Laser Diffraction Analyser, using the small volume (wet) module with 2-propanol as a dispersant. The key particle size distribution values for the test item are: D10 = 1.05 μm, D50 = 4.52 μm, D90 = 39.1 μm. 62.72% by volume of the sample was found to be < 10.00 µm. The MMAD of the sample is 7.97 µm.