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EC number: 949-790-7 | CAS number: -
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 April 2019 to 30 May 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- continuous drop method
- Type of particle tested:
- agglomerate
- Type of distribution:
- volumetric distribution
Test material
- Reference substance name:
- Reaction mass of 5,7-dimethoxy-3-(4-(sec-C10-C13-alkyl)-benzoyl)-2H-chromen-2-one
- EC Number:
- 949-790-7
- Molecular formula:
- Not applicable - UVCB
- IUPAC Name:
- Reaction mass of 5,7-dimethoxy-3-(4-(sec-C10-C13-alkyl)-benzoyl)-2H-chromen-2-one
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Test item: Esacure 3644
Appearance: Light yellow solid
Test item storage: At room temperature protected from light
Expiry date: 06 July 2019
Relative density: 1.14 (determined by Charles River Laboratories)
Results and discussion
Particle sizeopen allclose all
- Key result
- Percentile:
- D10
- Mean:
- 19.3 µm
- St. dev.:
- 0.105
- Key result
- Percentile:
- D50
- Mean:
- 75.2 µm
- St. dev.:
- 0.64
- Key result
- Percentile:
- D90
- Mean:
- 222 µm
- St. dev.:
- 6.57
- Key result
- Percentile:
- other: MMAD (mass median aerodynamic diameter)
- Mean:
- 80.3 µm
- St. dev.:
- 0.611
- Key result
- Percentile:
- other: Volume of sample < 10.00 µm
- Mean:
- 0.65 other: %
- Remarks on result:
- other: 0.65 % by volume of sample was seen to be < 10.00 µm
Any other information on results incl. tables
Solubility Test for Particle Size Analysis
Preliminary Solubility And Dispersability For Particle Size Analysis
The test item was well dispersed in both solvents tested. For the full solubility and dispersability test both solvents were selected.
Solubility And Dispersability Test For Particle Size Analysis
Dispersant used: 2-Propanol & Silicone Oil
The test item proved to be insoluble and well dispersed in both solvents. Both solvents were therefore trialled as the dispersant.
During the method development phase of the analysis trials were conducted using the small volume (wet) module only. The trials were conducted using 2-propanol and silicone oil as the dispersant. The results of these trials indicated that the most appropriate test and material parameters to obtain the optimum measurements were:
Module : Small volume module
Dispersant : Silicone oil
Dispersion speed : 1800 rpm
Refractive index (sample) : 0.000 n
Absorption : 0.000 AU
Analysis Model : General Purpose
Using the identified parameters, the particle size was analysed over the range 0.01 µm to 3500 µm. The results of the formal analysis are presented in Table 10:1. In addition, a graph of volume (%) versus Particle Diameter (µm), and full particle size distribution, is provided in Graph 10.A (Average of 5 runs).
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.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, 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.
- Executive summary:
Particle Size Distribution test was performed under GLP conditions on the test substance. In conclusion, 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.
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