Registration Dossier
Registration Dossier
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EC number: 262-810-2 | CAS number: 61477-95-0
Water solubility
Administrative data
Link to relevant study record(s)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 December 2018- 21 December 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7840 (Water Solubility)
- Version / remarks:
- Water Solubility: Column Elution Method; Shake Flask Method. March 1998.
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- flask method
- Specific details on test material used for the study:
- Name: Monalazone Disodium
Lot No. Purity Manufactured Date Expiry Date
72617S >99% excluding water 7/26/2017 2/1/2019 - Key result
- Water solubility:
- 404 g/L
- Conc. based on:
- test mat. (dissolved fraction)
- Temp.:
- 20 °C
- pH:
- 4
- Key result
- Water solubility:
- 397 g/L
- Conc. based on:
- test mat. (dissolved fraction)
- Temp.:
- 20 °C
- pH:
- 7
- Key result
- Water solubility:
- 400 g/L
- Conc. based on:
- test mat. (dissolved fraction)
- Temp.:
- 20 °C
- pH:
- 9
- Conclusions:
- The mean water solubility of the test item, Monalazone disodium, in double distilled water 410.38± 1.54 and the mean solubility in aqueous buffer solutions of pH 4.0, 7.0 and 9.0 was 404.217 ± 16.82, 397.240 ± 20.07 and 399.78 ± 7.75 g/L, respectively at 20 ± 0.5°C.
- Executive summary:
The objective of the study was to determine the solubility of the test item in double distilled water and in buffer solutions of pH 4.0 ± 0.1, pH 7.0 ± 0.1 and pH 9.0 ± 0.1.
The overall mean solubility of Monalazone disodium in double distilled water was determined to be 410.387± 4.052 at 20 ± 0.5°C. The overall mean solubility of the test item, Monalazone disodium, in pH 4.0 buffer was determined to be 413.853 ± 12.674 g/L at 20 ± 0.5°C. The overall mean solubility of the test item, Monalazone disodium, in pH 7.0 buffer was determined to be 377.840 ± 0.776 g/L at 20 ± 0.5°C. The overall mean solubility of the test item, Monalazone disodium, in pH 9.0 buffer was determined to be 390.941 ± 5.611 g/L at 20 ± 0.5°C.
Reference
Description of key information
Water solubility (Monalazone Disodium; OECD 105): 410 g/L
Key value for chemical safety assessment
- Water solubility:
- 410 g/L
- at the temperature of:
- 20 °C
Additional information
The overall mean solubility of Monalazone disodium in double distilled water was determined to be 410.387± 4.052 at 20 ± 0.5°C.The overall mean solubility of the test item, Monalazone disodium, in pH 4.0 buffer was determined to be 413.853 ± 12.674 g/L at 20 ± 0.5°C.The overall mean solubility of the test item, Monalazone disodium, in pH 7.0 buffer was determined to be 377.840 ± 0.776 g/L at 20 ± 0.5°C.The overall mean solubility of the test item, Monalazone disodium, in pH 9.0 buffer was determined to be 390.941 ± 5.611 g/L at 20 ± 0.5°C.
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