Registration Dossier
Registration Dossier
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EC number: 701-059-1 | CAS number: 345217-03-0
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 March 2012- 11 July 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and EC guidelines and according to the principles of GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- (1995)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7840 (Water Solubility)
- Version / remarks:
- (1998)
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- column elution method
Test material
- Reference substance name:
- 2,5-anhydro-4-{[4-(4-{4-[({1-[(2S,3S)- 2-(benzyloxy)pentan-3-yl]hydrazino}carbonyl)amino]phenyl}piperazin1-yl)phenoxy]methyl}-1,3,4-trideoxy-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)-
- EC Number:
- 701-059-1
- Cas Number:
- 345217-03-0
- Molecular formula:
- C43H50F2N8O4
- IUPAC Name:
- 2,5-anhydro-4-{[4-(4-{4-[({1-[(2S,3S)- 2-(benzyloxy)pentan-3-yl]hydrazino}carbonyl)amino]phenyl}piperazin1-yl)phenoxy]methyl}-1,3,4-trideoxy-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)-
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): PAZ-D
- Physical state: white powder
- Hygroscopic
Constituent 1
Results and discussion
Water solubilityopen allclose all
- Water solubility:
- 0.045 mg/L
- Temp.:
- 20 °C
- pH:
- 8.4
- Remarks on result:
- other: Flowrate 24 ml/h. Mean of 10 samples. CV=10%.
- Water solubility:
- 0.045 mg/L
- Temp.:
- 20 °C
- pH:
- 8.2
- Remarks on result:
- other: Flowrate 12 ml/h. Mean of 10 samples. CV=6.8%.
- Details on results:
- The coefficient of variation (n= 10) was ≤ 30% at both flow rates. It demonstrated that the system was equilibrated at all flow rates.
The maximum difference on the mean values at both flow rates was ≤ 30% (0.54% was calculated). The water solubility of the substance is given as the mean value of these measurements: 0.0453 mg/L.
Any other information on results incl. tables
No test substance was detected in the samples from the blank column.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
The column elution method was performed, resulting in a water solubility of 0.0453 mg/L. The study was performed in accordance with EC A.6, OECD 105 and EPA OPPTS 830.7840 guidelines and according to the principles of GLP.
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