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EC number: 201-288-2 | CAS number: 80-53-5
Particle size distribution (Granulometry)
Administrative data
Link to relevant study record(s)
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 May 2021 - 06 July 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Well documented study performed according to the guideline ISO 13320 and NF ISO 14887, under GLP and without deviation
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- other: NF ISO 14887 (Sample preparation – Dispersing procedures for powders in liquids)
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2021-03-17
- Type of method:
- Laser scattering/diffraction
- Type of distribution:
- volumetric distribution
- Mass median aerodynamic diameter:
- > 105.7 - < 546.5 µm
- No.:
- #1
- Size:
- < 2 µm
- Distribution:
- ca. 0 %
- No.:
- #2
- Size:
- > 2 - < 200 µm
- Distribution:
- ca. 63.96 %
- No.:
- #3
- Size:
- > 200 µm
- Distribution:
- ca. 36.04 %
- Conclusions:
- The particle size distribution of the test item P-MENTHANE-1,8-DIOL has been determined and the following results were obtained:
- 0.00 % of particles own a diameter under 2 μm.
- 63.96 % of particles own a diameter between 2 μm and 200 μm.
- 36.04 % of particles own a diameter over 200 μm. - Executive summary:
A study was performed to determine the Particle Size Distribution of the test item P-MENTHANE-1,8-DIOL. The method followed was designed to be compliant with the Guideline ISO 13320. (2020). Particle size analysis – Laser Diffraction methods.
In this method, the particle size distribution (PSD) is determined using a laser diffraction granulometer.
The laser diffraction technique for the determination of PSD is based on the phenomenon that particles scatter light in all directions with an intensity pattern that is dependent of particle size. This light pattern is recorded with captors placed in the laser diffraction granulometer.Using an optical microscope (x 100 magnification), the substance was visually confirmed as being a crystalline powder, not a fibre.
Four measurements were performed using dry way.
The following results were obtained from the mean of measurements 2, 3 and 4:
This particle size distribution has the following properties:
Per cent of particles with diameter ≤ 2 μm: 0 %
Per cent of particles with 2 μm ≤ diameter ≤ 200μm: 63.96 %
Per cent of particles with diameter ≥ 200 μm: 36.04 %
The following table summarizes the cumulative distribution between 2 μm and 200 μm:Diameter (μm) 2.0
10.1 22.8 34.3 44.9 59.0 77.3 101.5 152.5 200.0 Cumulative percentage of particles (%) 0.00 0.00 1.57 5.32 10.98 19.92 31.36 42.99 56.75 63.96 Moreover the particle size distribution deconvolution in two peaks gives the following data:
Peak
1 2 Median diameter value (μm) 105.7 546.5
Approximate area (%) 67.6 33.5 The particle size distribution of the test item P-MENTHANE-1,8-DIOL has been determined and the following results were obtained:
0.00 % of particles own a diameter under 2 μm.
63.96 % of particles own a diameter between 2 μm and 200 μm.
36.04 % of particles own a diameter over 200 μm.
Reference
Results:
Measurements 2, 3 and 4 were averaged and the following particle size distribution is observed.
Measurements:
This particle size distribution has the following properties:
- Per cent of particles with diameter ≤ 2 μm : 0 %
- Per cent of particles with 2 μm ≤ diameter ≤ 200μm : 63.96 %
- Per cent of particles with diameter ≥ 200 μm : 36.04 %
The following table summarizes the cumulative distribution between 2 μm and 200 μm:
| Diameter (μm) | 2.0 | 10.1 | 22.8 | 34.3 | 44.9 | 59.0 | 77.3 | 101.5 | 152.5 | 200.0 |
| Cumulative percentage of particles (%) | 0.00 | 0.00 | 1.57 | 5.32 | 10.98 | 19.92 | 31.36 | 42.99 | 56.75 | 63.96 |
Moreover the particle size distribution deconvolution in two peaks gives the following data:
Peak | 1 | 2 |
| Median diameter value (μm) | 105.7 | 546.5 |
| Approximate area (%) | 67.6 | 33.5 |
Description of key information
The particle size distribution of the test item P-MENTHANE-1,8-DIOL has been determined and the following results were obtained:
0.00 % of particles own a diameter under 2 μm.
63.96 % of particles own a diameter between 2 μm and 200 μm.
36.04 % of particles own a diameter over 200 μm.
Additional information
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