Registration Dossier
Registration Dossier
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EC number: 700-073-5 | CAS number: 1215036-04-6
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: In compliance with GLP guideline
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- column elution method
Test material
- Reference substance name:
- Isosorbide Diesters
- EC Number:
- 700-073-5
- Cas Number:
- 1215036-04-6
- Molecular formula:
- As it is an UVCB, we can not provide the exact molecular formula.
- IUPAC Name:
- Isosorbide Diesters
Constituent 1
Results and discussion
Water solubility
- Water solubility:
- <= 5 mg/L
- Temp.:
- 20 °C
- pH:
- 7
- Details on results:
- No isosorbide diesters could be observed in the collected fractions. The concentration of the diesters was defined to be lower than the limit of quantification (5 mg/L).Only the monoesters could be quantified. At both flow rates tested, the solubility is nearly the same for the monoesters (mean value: 39 mg/L).
The solubility of the monoesters is about eight times higher than the solubility of the diesters
The concentration of the monoester fraction is about eight times lower than the concentration of the diester fraction in the test item (see annex 2).
The hydrosolubility of the test item is therefore taken as the value accepted for the diester fraction.
The hydrosolubility of the test item is equal or lower than 5 mg/L.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
The hydrosolubility of diester d’isosorbide is equal or lower than 5 mg/L.
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