Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentations

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
GLP compliance:
no
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Purity: 99.3 %





Results and discussion

Water solubilityopen allclose all
Water solubility:
33.162 mg/L
Temp.:
20 °C
pH:
5.71
Remarks on result:
other: time: 7 days
Water solubility:
33.023 mg/L
Temp.:
20 °C
pH:
5.71
Remarks on result:
other: time: 7 days
Details on results:
Averaging the results of the two samples gives a mean solubility of 33.1 mg/l in water at 20° C and pH 5.71.

Any other information on results incl. tables

The investigation fo the insoluble residue by HPLC showed no increase of decomposition products. According X-ray powder diffration during equilibration a phase transition woth respect to the solid state from took place.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
1 alpha-Methyl-4-androstene-3,17-dione can be considered as slightly soluble with a mean solubility of 33.1 mg/l in water at 20 °C and pH 5.71.
Executive summary:

The water solubility of 1 alpha-Methyl-4-androstene-3,17-dione was determined using the flask method. The solubility with 95% confidence interval was obtained after equilibration at 20°C and separation from the insoluble residue. Averaging the results of two samples gave a mean solubility of 33.1 mg/l in water at 20° C. The pH value of the aqueous solution was determined to be 5.71.