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Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 July 2018 to 03 July 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Department of Health, United Kingdom.
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
2-phenylimidazole
EC Number:
211-581-7
EC Name:
2-phenylimidazole
Cas Number:
670-96-2
Molecular formula:
C9H8N2
IUPAC Name:
2-phenylimidazole
Test material form:
solid: flakes
Specific details on test material used for the study:
Please note that samples named 2PZ and 2PZ-PW are the same substance; 2PZ-PW is the crushed version of the substance.
The Applicant assumed that the crushed version of the substance would be more hazardous on some endpoints and therefore, that sample was used for some of the physicochemical studies.

Results and discussion

Particle sizeopen allclose all
Key result
Percentile:
D10
Mean:
ca. 9.01 µm
St. dev.:
0.063
Key result
Percentile:
D50
Mean:
ca. 24.2 µm
St. dev.:
0.248
Key result
Percentile:
D90
Mean:
ca. 95.2 µm
St. dev.:
5.44

Any other information on results incl. tables

Full test results

 

RUN 1

RUN 2

RUN 3

RUN 4

RUN 5

Average*

Volume weighted mean

42.9

43.7

40.9

39.3

43.4

42.0

Median

24.5

24.4

24.2

24.0

23.9

24.2

Mode

23.3

23.1

23.1

22.9

22.7

23.0

d10 (10 % of material is <)

9.08

9.06

9.00

8.98

8.93

9.01

d50 (50 % of material is <)

24.5

24.4

24.2

24.0

23.9

24.2

d90 (90 % of material is <)

103

97.9

92.8

88.1

96.3

95.2

All results are in μm

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

11.94 % by volume of sample was seen to be < 10.00 μm.

Standard Deviation results

Run No.

1

2

3

4

5

STDVP

%STDVP

d10 (10 % of material is <)

9.08

9.06

9.00

8.98

8.93

0.0634

0.704

d50 (50 % of material is <)

24.5

24.4

24.2

24.0

23.9

0.248

1.02

d90 (90 % of material is <)

103

97.9

92.8

88.1

96.3

5.44

5.69

GSD

2.877

2.899

2.829

2.786

2.912

0.047

1.6

GSD = Geometric standard deviation of the lognormal particle size distribution (calculated from d50/d15.78)

STDVP = standard deviation of the population

% STDVP = percentage standard deviation of the population

Coefficient of variation for d50 is less than 3% and for d10 is 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.

For d90 the coefficient of variation is greater than 5%. However, this could not be improved since the particles where found to agglomerate and application of ultrasonication was found to break up smaller particles. This must therefore be taken into consideration when interpreting the results which is represented by the secondary peak observed in the particle distribution trend.

Applicant's summary and conclusion

Executive summary:

The particle size distribution of the test item was measured in a GLP study performed using method ISO 13320 (Particle size analysis - Laser diffraction methods), using silicone oil as the dispersant. The particle size analysis produced the following results:

Summary of results

Particle Size Analysis using small volume (wet) module

(SVM).

Average (μm)

Volume weighted mean

42.0

Median (d.50)

24.2

Mode

23.0

10 % of material is <

9.01

50 % of material is <

24.2

90 % of material is <

95.2

by volume of sample was seen to be < 10.00 μm

11.94 %