Registration Dossier

Administrative data

Endpoint:
partition coefficient
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.8 (Partition Coefficient)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
Deviations:
no
GLP compliance:
no
Type of method:
HPLC method
Partition coefficient type:
octanol-water

Test material

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



Study design

Analytical method:
high-performance liquid chromatography

Results and discussion

Partition coefficient
Type:
log Pow
Partition coefficient:
2.65
Temp.:
25 °C
pH:
7
Remarks on result:
other: 95 % confidence limits 2.44 - 2.85

Applicant's summary and conclusion

Conclusions:
The partition coefficient (log Pow) of 1 alpha-Methyl-4-androstene-3,17-dione is 2.65 at 25°C and pH 7.
Executive summary:

The n-octanol/water partition coefficient (log Pow) of 1 alpha-Methyl-4-androstene-3,17-dione was determined according to EU Testing Guideline A.8 (HPLC method based on OECD guideline no. 117) to be 2.65 (95 % confidence limits 2.44 -2.85) which indicates considerable lipophilicity. The method is based on the correlation of the reversed phase retention data of the test compound with those of reference compounds with known log Pow values.