Registration Dossier

Physical & Chemical properties

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:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
no
Qualifier:
according to
Guideline:
other: CIPAC method MT 187
GLP compliance:
no
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

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.