Registration Dossier
Registration Dossier
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EC number: 465-100-2 | CAS number: -
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- OECD Guideline No. 105 for the testing of chemicals,
adopted 27 July 1995
- GLP compliance:
- yes
- Type of method:
- flask method
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- Batch number: 022401
Constituent 1
- Specific details on test material used for the study:
- Purity: >93 % (free base plus hydrochloride).
Free base: 79.8 %
Results and discussion
Water solubilityopen allclose all
- Water solubility:
- ca. 124.9 g/L
- Conc. based on:
- test mat.
- Incubation duration:
- ca. 3 d
- Temp.:
- 30 °C
- pH:
- > 5.4 - <= 5.5
- Key result
- Water solubility:
- 111 000 mg/L
- Conc. based on:
- test mat.
- Incubation duration:
- ca. 3 d
- Temp.:
- 20 °C
- pH:
- > 5.4 - <= 5.5
- Details on results:
- As the temperature coefficient of the solubility of the test substance was <3 % (i.e. 2.3 %)
per °C, the solubility was not determined at other temperatures, in agreement with the
guideline.
Applicant's summary and conclusion
- Conclusions:
- The water solubility of "STI571 F8" was determined to:
Mean: 111.0 g/L, standard deviation: 5.9, three replicates, temperature 20.0 °C
Mean: 124.9 g/L, standard deviation: 1.1, three replicates, temperature 30.0 °C
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