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EC number: 200-554-5 | CAS number: 63-05-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 to 21 Nov 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- yes
- Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- Incubation time: 5 days
- Buffers:
- Buffer solutions:
- 0.05 M acetate buffer solution pH 4
- 0.05 M phosphate buffer solution pH 7
- 0.05 M borate buffer pH 9
Buffer solutions for calibration of pH meter and electrode:
- standard buffer solutions pH 4 (Art. 33543), pH 7 (Art. 33546), pH 9 (Art. 33548) - Details on test conditions:
- - alliquots of test item filled into sterilized 5 ml autosampler vials, lightly closed with screw caps
- incubated at 50 +/- 0.1 °C in a thermostatic water bath for 5 days
- pH values measured at the start of incubation and at the end of hydrolysis experiment
- possible photolytic degradation was prevented by exclusion of light from the hydrolysis solutions by using a thermostatic bath made of stainless steel with metal cover
- after 5 days the samples were analyzed by HPLC - Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 10 mg/L
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 10 mg/L
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 10 mg/L
- Number of replicates:
- The initial concentration was measured in triplicate.
- Preliminary study:
- No hydrolytic degradation was observed within 5 days at pH 4, 7 and 9 at 50 ± 0.1 °C.
- Transformation products:
- no
- % Recovery:
- 100.4
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 5 d
- % Recovery:
- 101
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 5 d
- % Recovery:
- 99.9
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 5 d
- Key result
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Remarks on result:
- other: "considered to" be acc. to the EC-Test Guideline
- Details on results:
- The data show that at pH 4, 7 and 9 essentially no hydrolysis occured within 5 days at 50 +/- 0.1 °C. Therefore the test item is considered to be hydrolytically stable (t1/2 > 1 year at 25 °C) and no further testing is necessary.
- Conclusions:
- Androst-4-ene-3,17-dione can be considered to be hydrolytically stable at pH 4, 7 and 9 at 25 °C.
- Executive summary:
The rate of hydrolysis of Androst-4-ene-3,17-dione in aqueous solution buffered to pH values of 4, 7 and 9 was studied according to EU testing guideline C.7. No hydrolytic degradation was observed within 5 days at pH 4, 7 and 9 at 50 ± 0.1 °C (pretest).
Reference
Validity criteria for the hydrolysis study:
Target condition according to guideline: | Actual condition according to the study: | Validity criteria met: |
The analytical method used will depend on the nature of the substance and must be sufficiently precise and sensitive to detect a reduction of 10 % of the initial concentration. | Analysis via HPLC is sensitive enough to detect a reduction of 10% of the initial concentration. | Yes |
A sufficient number of samples (not less than four) should be chosen to cover the range 20 to 70 % of hydrolysis to test for pseudo-first order behaviour at the specified pH values. | pH 4 (50°C): 6 measurements pH 7 (50°C): 6 measurements pH 9 (50°C): 6 measurements | Yes |
The temperature, pH value, buffer composition and a table of all concentration-time data points shall be stated. | The temperature, pH value, buffer composition and a table of all concentration-time data points is stated for each test. | Yes |
Description of key information
Androst-4-ene-3,17-dione can be considered to be hydrolytically stable at pH 4, 7 and 9 at 25 °C.
Key value for chemical safety assessment
Additional information
No hydrolytic degradation was observed within 5 days at pH 4, 7 and 9 at 50 ± 0.1 °C (pretest). Therefore no further testing is required.
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