Registration Dossier
Registration Dossier
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EC number: 202-739-6 | CAS number: 99-20-7
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:
- 03. Apr. - 15. Nov. 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- Laser scattering/diffraction
- Type of particle tested:
- primary particle
- Type of distribution:
- volumetric distribution
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 160805
- Expiration date of the lot/batch: 05 August 2018
- Purity test date: not stated
RADIOLABELLING INFORMATION (if applicable)
not applicable
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient temperature, keep away from humidity
- Stability under test conditions: assumed stable
- Solubility and stability of the test substance in the solvent/vehicle: not applicable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
none - Key result
- Percentile:
- D10
- Mean:
- 72 µm
- St. dev.:
- 1.27
- Remarks on result:
- other:
- Key result
- Percentile:
- D50
- Mean:
- 310.9 µm
- St. dev.:
- 7.21
- Key result
- Percentile:
- D90
- Mean:
- 656.2 µm
- St. dev.:
- 6.5
- Conclusions:
- The test item TREHALOSE, ANHYDROUS has a median particle size of D50= 311 μm,
which was determined by laser diffraction measurement
Reference
Description of key information
guideline study,
The median particle size is determined to be D50= 311 μm
Additional information
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