Registration Dossier
Registration Dossier
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EC number: 234-293-3 | CAS number: 11071-15-1
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30/09/2011
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
- Principles of method if other than guideline:
- The samples were examined by laser diffraction in order to determine the Mass median aerodynamic diameter (MMAD); this is also known as the geometric mean aerodynamic diameter.
The analysis was carried out using the Coulter LS230 Laser Diffraction Particle Size Analyser fitted with the Dry Powder Module. The analysis was carried out 5 times. 3 of the 5 runs were then averaged to produce the results in the table below.
Optical Model: The calculation of particle size requires optical values of the material for increased accuracy; for this work we used a refractive index of 1.645 (determined by immersing the material in refractive index matching oils) and an imaginary component of 0.0. - Type of method:
- Laser scattering/diffraction
- Type of distribution:
- mass based distribution
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 28300-74-5
- Molecular formula:
- C8H4K2O12Sb2 ∙ 3H2O
- Details on test material:
- Batch no. 11/44 Intertek ref 11-0702
Batch no. 11/63 Intertek ref 11-0702
Constituent 1
- Specific details on test material used for the study:
- The test has been carried out on the substance itself (Antimony Potassium Tartrate).
Results and discussion
- Mass median aerodynamic diameter:
- >= 46 - <= 52.1 µm
- Geometric standard deviation:
- >= 0.9 - <= 254.54
Particle size
- Key result
- Percentile:
- D50
- Mean:
- >= 46 - <= 52.1 µm
- St. dev.:
- 254.54
Applicant's summary and conclusion
- Conclusions:
- The laser diffraction tests performed to conduct particle size distribution studies on two batchess originating from different producers of the substance Antimony Potassium Tartrate, indicate a mass median aerodynamic diameter of 46.0 - 52.1 micrometers. A maximum of 5.14% of the particles have a diameter below 10 micrometers, corresponding to the respirable fraction.
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