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EC number: 254-074-6 | CAS number: 38668-46-1
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 June 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- 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
- Reference substance name:
- 6-[2-(2-methyl-1H-imidazol-1-yl)ethyl]-1,3,5-triazine-2,4-diamine
- EC Number:
- 254-074-6
- EC Name:
- 6-[2-(2-methyl-1H-imidazol-1-yl)ethyl]-1,3,5-triazine-2,4-diamine
- Cas Number:
- 38668-46-1
- Molecular formula:
- C9H13N7
- IUPAC Name:
- 6-[2-(2-methyl-1H-imidazol-1-yl)ethyl]-1,3,5-triazine-2,4-diamine
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Please note that samples named 2MZ-A and 2MZA-PW are the same substance; 2MZA-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. 15.3 µm
- St. dev.:
- 0.053
- Key result
- Percentile:
- D50
- Mean:
- ca. 46.8 µm
- St. dev.:
- 0.14
- Key result
- Percentile:
- D90
- Mean:
- ca. 107 µm
- St. dev.:
- 0.426
Any other information on results incl. tables
Full test results
|
RUN 1 |
RUN 2 |
RUN 3 |
RUN 4 |
RUN 5 |
Average** |
Volume weighted mean |
55.2 |
55.0 |
54.9 |
55.0 |
55.3 |
55.1 |
Median |
46.7 |
46.8 |
46.6 |
46.8 |
47.0 |
46.8 |
Mode |
53.3 |
53.9 |
53.5 |
54.0 |
53.9 |
53.7 |
MMAD* |
54.240 |
54.353 |
54.156 |
54.413 |
54.580 |
54.4 |
d10 (10 % of material is <) |
15.2 |
15.3 |
15.3 |
15.3 |
15.4 |
15.3 |
d50 (50 % of material is <) |
46.7 |
46.8 |
46.6 |
46.8 |
47.0 |
46.8 |
d90 (90 % of material is <) |
108 |
107 |
107 |
107 |
107 |
107 |
All results are in μm
* Mass median aerodynamic diameter
** Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.
5.40 % 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 <) |
15.2 |
15.3 |
15.3 |
15.3 |
15.4 |
0.0527 |
0.344 |
d50 (50 % of material is <) |
46.7 |
46.8 |
46.6 |
46.8 |
47.0 |
0.140 |
0.300 |
d90 (90 % of material is <) |
108 |
107 |
107 |
107 |
107 |
0.426 |
0.398 |
GSD |
2.456 |
2.458 |
2.460 |
2.457 |
2.451 |
0.003 |
0.1 |
MMAD |
54.240 |
54.353 |
54.156 |
54.413 |
54.580 |
0.146 |
0.3 |
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%; 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.
Applicant's summary and conclusion
- Conclusions:
- MMAD (Mass Median Aerodynamic Diameter) of the test substance was 54.4.
- 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 2-Propanol 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
55.1
Median (d.50)
46.8
Mode
53.7
MMAD(Mass Median Aerodynamic Diameter)
54.4
10% of material is<
15.3
50% of material is<
46.8
90% of material is<
107
by volume of sample was seen to be < 10.00 μm
5.40 %
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