Registration Dossier

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:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
GLP compliance:
yes (incl. certificate)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent

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.