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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:
2009-09-04 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): DD Lactide
- Batch no: 0809002497
- Purity 100 %
- Expiration date of the lot/batch: 2009-009-23
- Stability under storage conditions: stable
- test substance storage: at room temperature in the dark
- sample density: 1.31 g/cm3

Results and discussion

Solubility in organic solvents / fat solubilityopen allclose all
Medium:
other: sunflower oil
Solubility:
other: insoluble
Remarks on result:
other: particle disintegration observed under microscope
Medium:
other: silicone oil
Solubility:
other: insoluble
Remarks on result:
other: insoluble, good dispersion
Medium:
other: kerosene
Solubility:
other: insoluble
Remarks on result:
other: insoluble, but poor dispersion
Medium:
toluene
Solubility:
other: soluble

Applicant's summary and conclusion

Conclusions:
DD-lactide was found to be insoluble in kerosene, silicone oil and sunflower 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. DD-lactide is insoluble in kerosene, silicone oil and vegetable oils, but soluble in toluene.