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Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24.08.2009 - 03.11.2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to guideline under GLP
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Principles of method if other than guideline:
Not relevant
GLP compliance:
yes (incl. certificate)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): R-Pantolactone
- Physical state: solid
- Analytical purity: 99.6%
- Stability under test conditions: yes
- Storage condition of test material: RT

Results and discussion

Water solubility
Water solubility:
540.2 g/L
Temp.:
21.8 °C
pH:
3.9

Any other information on results incl. tables

No further remarks

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): soluble (1000-10000 mg/L)
During this study the water solubility of R-Pantolactone at room temperature was determined
using a simplified flask method and was found to be > 540.2 g/L at 21.8 OC and a pH of 3.9
Executive summary:

The determination of the water solubility of R-Pantolactone was performed according to the OECD Guideline No. 105 "Water Solubility" (1995) using a simplified flask method.

After mixing a total of about 5.2 g of test item in 5 mL of water (which corresponds to a visual

determined solubility of > 1.0 kdL) the test item was completely dissolved. It was not possible

to prepare a saturated solution before obtaining a 1:l mixture, therefore, the water solubility of

R-Pantolactone might be higher as determined in this test. The determination of the

concentration in the above mentioned test item / water mixture was confirmed by HPLC.

Details of the preliminary test are given in Table 1.