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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
other information
Study period:
2002-04-18 to 2002-11-29
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Deviations:
yes
Principles of method if other than guideline:
At pH values where more than 10 % degradation was observed under the conditions of the preliminary test (5 days at 50 °C), experiments at elevated temperatures were necessary in order to extrapolate from the hydrolysis rate constants determined at elevated temperatures to the hydrolysis rate constant at 25 °C. Those experiments were conducted only at one elevated temperature instead of two elevated temperatures. This is justified since acceptable results were obtained.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
5-hydroxy-15β,16β-methylene-3β-pivaloyloxy-5β-androst-6-en-17-one
EC Number:
617-345-3
Cas Number:
82543-14-4
Molecular formula:
C25H36O4
IUPAC Name:
5-hydroxy-15β,16β-methylene-3β-pivaloyloxy-5β-androst-6-en-17-one
Radiolabelling:
no

Study design

Analytical monitoring:
yes
Duration of testopen allclose all
Duration:
142.8 h
pH:
4
Temp.:
50 °C
Initial conc. measured:
0.297 mg/L
Duration:
143 h
pH:
7
Temp.:
50 °C
Initial conc. measured:
0.329 mg/L
Duration:
600 h
pH:
9
Temp.:
50 °C
Initial conc. measured:
0.329 mg/L
Duration:
44.3 h
pH:
9
Temp.:
80 °C
Initial conc. measured:
0.247 mg/L

Results and discussion

Transformation products:
not measured

Any other information on results incl. tables

The hydrolysis of ZK 90504 is base-catalyzed. At alkaline pH values the free alcohol ZK 38700

is the hydrolysis product. Due to the very low concentration of the hydrolysis solutions and the low UV absorbance of the

product, it could not be identified in the HPLC diagrams.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Executive summary:

The rate of hydrolysis of ZK 90504 was determined at pH 4, 7 and 9.

Less than 10 % of the test substance were degraded within 5 days at 50 °C at pH 4 and 7.

Therefore ZK 90504 can be considered hydrolytically stable at pH 4 and 7 and no further

experiments were necessary.

Since more than 10 % decay was observed at pH 9 within 5 days at 50 °C, hydrolysis

experiments at elevated temperatures were necessary. Therefore an additional experiment was

conducted at 80 °C. However, extrapolation of the experimentally determined rate constants at pH 9, 50 and 80 °C, to the rate constant at 25 °C gave a half-life > 1 year at pH 9, 25 °C. Therefore, according to the criterion in EC guideline C.7 (half-life > 1 year at 25 °C) the test substance is to be considered stable at pH 4, 7 and 9, 25 °C.