Registration Dossier
Registration Dossier
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EC number: 224-832-0 | CAS number: 4511-42-6
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
Test material
- Reference substance name:
- (3S-cis)-3,6-dimethyl-1,4-dioxane-2,5-dione
- EC Number:
- 224-832-0
- EC Name:
- (3S-cis)-3,6-dimethyl-1,4-dioxane-2,5-dione
- Cas Number:
- 4511-42-6
- Molecular formula:
- C6H8O4
- IUPAC Name:
- 3,6-dimethyl-1,4-dioxane-2,5-dione
Constituent 1
Results and discussion
Water solubility
- Water solubility:
- 16.7 g/L
- Temp.:
- 20.1 °C
- pH:
- 2
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): very soluble (> 10000 mg/L)
Lactide is soluble in water, but the solubility is limited, if by nothing else, by its hydrolytic instability. - Executive summary:
Two methods are available for the determination of the water solubility of a test substance:
1. Column elution method The method is based on the elution of the test substance with water from a column which is charged with an inert support material, such as bare silica particles, coated with an excess of the test substance. It can be applied to test substances with a water solubility of less than 10 mg/L.
2. Flask method The mass concentration of the test substance in aqueous solutions saturated with the test substance will be determined after stirring or shaking at a specific temperature for a specific period of time. The method can be used for test substances with a water solubility of >= 10 mg/L. A preliminary test was carried out as a range-finding test prior to performance of the column elution method or flask method. Because degradation was expected to occur rapidly, it was decided to perform a preliminary test to see what maximum LL-Lactide concentration would be reached. To prevent degradation during sample pre-treatment as much as possible, it was decided to remove undissolved test substance by filtration since this takes less time than centrifugation.
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