Registration Dossier
Registration Dossier
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EC number: 249-070-6 | CAS number: 28535-81-1
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been carried out accordin to OECD testing guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC method MT 187
- GLP compliance:
- no
- Type of distribution:
- volumetric distribution
Test material
- Reference substance name:
- Ursodeoxycholic acid
- EC Number:
- 204-879-3
- EC Name:
- Ursodeoxycholic acid
- Cas Number:
- 128-13-2
- IUPAC Name:
- 3,7-dihydroxycholan-24-oic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Results and discussion
Particle sizeopen allclose all
- Percentile:
- D50
- Mean:
- 14.4 µm
- Remarks on result:
- other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
- Percentile:
- D10
- Mean:
- 1.31 µm
- Percentile:
- D50
- Mean:
- 14.5 µm
- Percentile:
- D90
- Mean:
- 57.3 µm
Particle size distribution at different passagesopen allclose all
- Size:
- < 50 µm
- Distribution:
- <= 86.7 %
- Size:
- > 75 µm
- Distribution:
- <= 4.9 %
Applicant's summary and conclusion
- Conclusions:
- From the experimental data obtained according to CIPAC method MT 187 and OECD guideline No. 110, it can be concluded that 86.7% of the Ursodeoxycholic acid sample presents a particle size lower than 50 μm and 4.9% of test item was found above 75 μm.
- Executive summary:
From the experimental data obtained according to CIPAC method MT 187 and OECD guideline No. 110, it can be concluded that 86.7% of the Ursodeoxycholic acid sample presents a particle size lower than 50μm and 4.9% of test item was found above 75μm.
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