Registration Dossier
Registration Dossier
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EC number: 207-096-5 | CAS number: 434-03-7
Hydrolysis
Administrative data
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ethisterone
- EC Number:
- 207-096-5
- EC Name:
- Ethisterone
- Cas Number:
- 434-03-7
- Molecular formula:
- C21H28O2
- IUPAC Name:
- (1R,3aS,3bR,9aR,9bS,11aS)-1-ethynyl-1-hydroxy-9a,11a-dimethyl-1H,2H,3H,3aH,3bH,4H,5H,7H,8H,9H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-7-one
Constituent 1
- Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
Duration of testopen allclose all
- Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 0.107 mg/L
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 0.113 mg/L
- Duration:
- 120 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 0.109 mg/L
Results and discussion
Any other information on results incl. tables
Table1: Sampling times, pH values of the hydrolysis solutions at 50 °C and the measured concentrations of ZK 4957 in the hydrolysis solutions.
test solution |
time |
pH value |
concentration (mean) |
standard deviation of mean concen-tration [mg/L] |
concentration (mean) in % of initial concentration |
|
pH 4 |
0.0 72.0 120.0 |
3.82 3.99 4.00 |
0.107 0.104 0.103 |
0.002 0.002 0.003 |
100.0 97.2 96.3 |
|
pH 7 |
0.0 72.0 120.0 |
6.96 6.96 6.96 |
0.113 0.111 0.109 |
0.003 0.002 0.002 |
100.0 98.2 96.5 |
|
pH 9 |
0.0 72.0 120.0 |
8.95 9.00 9.00 |
0.109 0.107 0.108 |
0.003 0.002 0.002 |
100.0 98.2 99.1 |
Applicant's summary and conclusion
- Conclusions:
- The test compound is considered to be hydrolytically stable at pH 4, 7 and 9 and 25 °C.
- Executive summary:
The rate of hydrolysis of ZK 4957 was determined according to EC guideline C.7 at pH 4, 7 and 9.
At pH 4, 7 and 9 less than 10 % of the initial concentration were degraded within 5 days at 50 +/- 0.1 °C.
According to the EC guideline, ZK 4957 is therefore considered hydrolytically stable at pH 4, 7 and 9 and 25 °C.
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