Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
hydrolysis
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Results and discussion

Dissipation DT50 of parent compoundopen allclose all
pH:
4
Temp.:
25 °C
DT50:
> 1 yr
Remarks on result:
other: estimation
pH:
7
Temp.:
25 °C
DT50:
> 1 yr
Remarks on result:
other: estimation
pH:
9
Temp.:
25 °C
DT50:
ca. 27 d
Remarks on result:
other: estimation

Any other information on results incl. tables

Test substance (ZK 5180)

17 beta-Acetoxy-5alpha-androstan-3-one

Analogous compound (ZK 5777)

 

17 beta-Acetoxy-5 alpha-androst-1-en-3-one

Kinetic data for hydrolysis of ZK 5777at 25°C (Schering report MR27)

pH

rate constant k [h–1]

(or statement)

half-life, t1/2

 

4

7

9

stable

stable

1.070 · 10-3

> 1 year

> 1 year

27 days

 

“Stable” signifies that less than 10 % of the test substance were degraded at the respective pH value during 5 days at 50 °C, corresponding to a half-life > 1 year at 25 °C.

Applicant's summary and conclusion

Executive summary:

The only hydrolyzable functional group in androstanolon-acetat is the ester function in position17. The hydrolytic behaviour is expected to be similar to that of the structurally closely related compound delta 1- androstenolen-acetat , which differs in an additional double bond in ring A of the steroid moiety, only.

The rate of hydrolysis of this compound was determined according to EC guideline C.7 at pH 4, 7 and 9. The compound was found to be hydrolytically stable at pH 4 and pH 7 at 25 °C. The half-lives at pH 9, 25 °C was 27 days.

Comparable results are to be expected for androstanolon-acetat.