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EC number: 211-995-8 | CAS number: 734-32-7
- 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:
- 2016
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Deviations:
- no
- 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:
- - pH of the blank buffer solution: checked at the beginning of the test
- pH of the hydrolysis solution: measured at each test point
- Temperature during the experiment: checked at each test point
- The repeatability of the peak areas of the investigated components was checked by analyzing an independent control solution of the test item
- Suitability of the HPLC system during the hydrolysis study: verified on every day of application
- Calibration: verified at each day of analysis at the level of 90.22 mg/L by using a control calibration solution - Buffers:
- BUFFERS:
- Buffer pH 4: Citric acid/NaOH/NaCl (Fluka, Order no.: 33643)
- Buffer pH 7: KH2PO4/Na2HPO4 (Fluka, Order no.: 33646)
- Buffer pH 9: Na2B4O7/HCl (Fluka, Order no.: 33648) - Details on test conditions:
- TEST DESIGN:
- 230.8 mg of the test item was weighed in a 25 mL measuring flask which was then filled to the mark with acetonitrile, resulting in a final concentration of approx. 9.21 g/L
- For each pH separate hydrolysis test solutions were prepared by dilution of 1 mL of the test item stock solution with 100 mL of the corresponding buffer systems
- Solubility and test concentration: aqueous solution (including 1 % acetonitrile) with a concentration of approx. 95 mg/L (WSL: 191 mg/L)
- Test item concentration: 92.14 mg/L
- Preparation was carried out under nitrogen as flushing gas
- The vials were closed and incubated at 50 °C in a water bath under dark
- At each test point the hydrolysis solution was directly led to the chromatographic measurement
- pH determination: pH-meter equipped with a calibrated single-rod glass electrode - Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50
- Initial conc. measured:
- 92.213 mg/L
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50
- Initial conc. measured:
- 91.579 mg/L
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50
- Initial conc. measured:
- 92.409 mg/L
- Number of replicates:
- None
- Transformation products:
- no
- % Recovery:
- 97.8
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 5 d
- % Recovery:
- 98.3
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 5 d
- % Recovery:
- 95.6
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 5 d
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: estimated (see "Details for result")
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: estimated (see "Details for result")
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: estimated (see "Details for result")
- Details on results:
- The overall degradation of the test item observed at 50 °C after 5 days at pH 4, 7 and 9 was less than 10 %. The test item is therefore considered to be stable at 50 °C. Therefore the substance can be considered hydrolytically stable, i.e. ty, > 1 year at 25 °C. Because no degradation was observed, no sterility test was performed in this case. No further tests at other temperatures are required for pH 4, 7 and 9.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The substance can be considered to be hydrolytically stable at pH 4, 7 and 9 at 25 °C.
- Executive summary:
The test was performed according to OECD Guidelines for Testing of Chemicals, Section 1 "Physical-Chemical Properties, OECD TG 111, Council Regulation (EC) No 440/2008, Guideline Part C" Methods for the Determination of Ecotoxicity, C.7. "Abiotic Degradation: Hydrolysis as a Function of pH" The hydrolysis behaviour of the test item was investigated at 50 °C at pH 4, pH 7 and pH 9 over a period of five days according to OECD TG 111. The stability was monitored by HPLC analysis using UV-detection. After 5 days no abiotic degradation of the test item was observed. The substance was found to be stable at 50 °C at all three pH-values. Therefore it can be assumed that the test item is also stable at 25 °C and no half-life times and hydrolysis rates were calculated.
Reference
Description of key information
The substance is hydrolytically stable at pH 4, pH 7 and pH 9 (25°C).
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 1 yr
- at the temperature of:
- 25 °C
Additional information
"Should read: > 1 year at 25 °C"
No hydrolytic degradation was observed within 5 days at pH 4, 7 and 9 at 50 °C. Therefore no further testing was required and the substance can be considered to be hydrolytically stable at pH 4, 7 and 9 and 25 °C.
This notion is also experimentally supported by the results of a hydrolysis study with estr-4 -ene-3,17 -dione which is structurally similar. Estr-4-ene-3,17-dione was found to be hydrolytically stable in the pH region 4 - 9 and 25 °C.
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