Registration Dossier

Physical & Chemical properties

Solubility in organic solvents / fat solubility

Administrative data

Endpoint:
solubility in organic solvents / fat solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-09-03 to 2009-10-08
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study, but no guideline followed

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: flakes
Details on test material:
- Name of test material (as cited in study report): LL Lactide
- Batch no: 0902000694
- Purity 100 %
- Expiration date of the lot/batch: 2010-02-10
- Stability under storage conditions: stable
- test substance storage: at room temperature in the dark
- sample density: 1.33 g/cm3

Results and discussion

Solubility in organic solvents / fat solubilityopen allclose all
Medium:
other: sunflower oil
Solubility:
other: insoluble
Remarks on result:
other: insoluble, well dispersed
Medium:
other: silicone oil
Solubility:
other: insoluble
Remarks on result:
other: insoluble, well dispersed
Medium:
other: kerosene
Solubility:
other: insoluble
Remarks on result:
other: insoluble, but poor dispersion stability
Medium:
toluene
Solubility:
other: soluble

Applicant's summary and conclusion

Conclusions:
In conclusion, it can be stated that LL-lactide is insoluble in kerosene, silicone oil and vegetable oils, but soluble in toluene.
Executive summary:

The solubility of the test item in organic solvents was assesed in a GLP non-guideline study. A small quantity of the test item sample was added to 25 mL of different solvents and the mixtures were vortexed for 10 seconds. LL lactide is insoluble in kerosene, silicone oil and vegetable oil, but soluble in toluene.