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Diss Factsheets

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- and Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method

Test material

Results and discussion

Water solubility
Water solubility:
ca. 255 mg/L
Temp.:
20 °C
pH:
ca. 6.9

Any other information on results incl. tables

FINAL RESULTS

The water solubility CS of the test item was determined at 20°C according to the "flask method"

described in the European Commission Council regulation (EC) No 440/2008. Annex. Part A. A.6.,

OECD-Guideline 105 and the EPA Product Properties Test Guideline OPPTS 830.7840.

The concentrations of the test item were determined by HPLC analysis.

The reversed-phase HPLC method used was found to be valid.

The results of the solubility measurements are shown below:

Solubility in                     Final pH        CS Solubility at 20°C       RSD

Double distilled water       6.9 1)                     255 * 10 -3 g/L        1.1 %

1) Mean pH – value resulting from three experiments

The sample purity of 98.5 % w/w has been taken into account.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): moderately soluble (100-1000 mg/L)