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EC number: 606-682-1 | CAS number: 2098-65-9
Hydrolysis
Administrative data
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Mar - Apr 1997
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 17-Hydroxy-1 alpha,2 alpha-methylene-4,6-pregnadiene-3,20-dione
- EC Number:
- 606-682-1
- Cas Number:
- 2098-65-9
- Molecular formula:
- C22 H28 O3
- IUPAC Name:
- 17-Hydroxy-1 alpha,2 alpha-methylene-4,6-pregnadiene-3,20-dione
- Test material form:
- solid: bulk
Constituent 1
- Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
- Buffers:
- - pH: 4
- Type and final molarity of buffer: 0.05 M
- Composition of buffer: 0.74 g = 0.009 mole sodium acetate p.a. Merck Art. 6268 (M = 82.03 g/mol) and 2.4 mL= 0.042 mole acetic acid 100 % p.a. Merck Art. 63 E (M = 60.05 g/mol, density = 1.05 g/mL) were dissolved to 1000 ml with double distilled water.
- pH: 7
- Type and final molarity of buffer: 0.05 M
- Composition of buffer: 4.34 g = 0.031 mole disodium hydrogen phosphate Merck Art. 106566 (M = 141.96 g/mol) and 2.64 g = 0.019 mole potassium dihydrogen phosphate Merck Art. 4881 (M = 136.09 g/mol) were dissolved to 1000 mL with double distilled water.
- pH: 9
- Type and final molarity of buffer: 0.05 M
- Composition of buffer: 4.78 g = 0.012 mole disodium tetraborate Merck Art. 6315 (M = 381.37 g/mol) and 46 mL = 0.0046 mole hydrochloric acid Titrisol Merck Art. 9944 (M = 36.46 g/mol) were dissolved to 1000 mL with double distilled water. - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: 5 mL autosampler vials (tightly closed) incubated in a thermostatic bacth
- Measures taken to avoid photolytic effects: darkness
TEST MEDIUM
- Volume used/treatment: 5 mL
- Preparation of test medium: Three test solutions, buffered to pH values of 4,7 and 9, each with a ZK 12 126 concentration of approx. 1 mg/L, were prepared by adding a stock solution of ZK 12126 in acetonitrile to the corresponding buffer solution which had been equilibrated at 50 °C for one hour followed by purging with nitrogen to remove dissolved oxygen. All experiments were conducted using sterilized equipment and buffer solutions.
Duration of testopen allclose all
- Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 1.016 mg/L
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 1.01 mg/L
- Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 1.019 mg/L
- Number of replicates:
- 3 replicates
- Positive controls:
- no
- Negative controls:
- no
Results and discussion
- Transformation products:
- no
Total recovery of test substance (in %)open allclose all
- % Recovery:
- 100.2
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 120 h
- % Recovery:
- 101.8
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 120 h
- % Recovery:
- 98.1
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 120 h
Dissipation DT50 of parent compoundopen allclose all
- Key result
- pH:
- 4
- Temp.:
- 25 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 7
- Temp.:
- 25 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 9
- Temp.:
- 25 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
Applicant's summary and conclusion
- Conclusions:
- No hydrolytic degradation was observed within 5 days at pH 4 and 7 at 50 ± 0.1 °C. Less than 10 % hydrolysis occured at pH 9 at pH 4 and 7 within 5 days at 50 ± 0.1 °C.
- Executive summary:
ZK 12126 is hydrolytically stable at pH 4, 7 and 9 and 25 °C (DT50 > 1 yr) .
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