Registration Dossier
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EC number: 942-982-1 | CAS number: -
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Principles of method if other than guideline:
- Particle size analysis was conducted using a Cilas 1064 from Quantachrome and specific surface area (BET) was conducted using a NOVA 1000 from Quantachrome.
- GLP compliance:
- no
- Other quality assurance:
- other: analytical lab is certified under ISO 9001:2008
- Type of method:
- Laser scattering/diffraction
- Type of particle tested:
- primary particle
- Type of distribution:
- counted distribution
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: An amount of 0.5 g powder was mixed with a mixture of 0.5 mL deionised water and Perovit before particle size analysis.
FORM AS APPLIED IN THE TEST: wet dispersion - Percentile:
- D10
- Mean:
- 0.34 µm
- Remarks on result:
- other: Standard deviation not reported.
- Key result
- Percentile:
- D50
- Mean:
- 1.26 µm
- Remarks on result:
- other: Standard deviation not reported.
- Percentile:
- D90
- Mean:
- 3.8 µm
- Remarks on result:
- other: Standard deviation not reported.
- Conclusions:
- The average 10th, 50th and 90th percentile particle sizes for uvertihe were 0.34, 1.26 and 3.80 μm, respectively. The specific surface area was determined as 5.7 m2/g.
- Executive summary:
The particle size distribution of uverithe was determined by laser diffraction analysis following wet dispersion. The specific surface area was determined according to the BET multipoint method using the adsorption isotherm. This is a non-GLP experimental study and there are minor restrictions in reporting but it follows standard methods for assessing particle size distribution and specific surface area and is acceptable as the key study for this endpoint.
The average 10th, 50th and 90th percentile particle sizes for uverithe were 0.34, 1.26 and 3.80 μm, respectively. The specific surface area was determined as 5.7 m2/g.
Reference
Specific surface area (BET) was determined to be 5.7 m2/g.
Description of key information
The average 10th, 50th and 90th percentile particle sizes for uverithe were 0.34, 1.26 and 3.80 μm, respectively. The specific surface area was determined as 5.7 m2/g.
Additional information
The particle size distribution of uverithe was determined by laser diffraction analysis following wet dispersion. The specific surface area was determined according to the BET multipoint method using the adsorption isotherm (Schefter 2016). This is a non-GLP experimental study and there are minor restrictions in reporting but it follows standard methods for assessing particle size distribution and specific surface area and is acceptable as the key study for this endpoint.
The average 10th, 50th and 90th percentile particle sizes for uverithe were 0.34, 1.26 and 3.80 μm, respectively. The specific surface area was determined as 5.7 m2/g.
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