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EC number: 219-868-9 | CAS number: 2556-10-7
- 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:
- 02 February 2017 - 12 July 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 835.2120 (Hydrolysis of Parent and Degradates as a Function of pH at 25°C)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes
- Radiolabelling:
- no
- Analytical monitoring:
- yes
- Remarks:
- LC-UV
- Details on sampling:
- PREPARATION OF THE SAMPLES
- Tier 1 (pH 4, 7 and 9) and tier 2 (pH 4 and 7) tests were performed.
- Test item was spiked to each sterile and oxygen-free buffer using a spiking solution in acetonitrile. Target concentration: 10 mg/L
- For each sampling time, duplicate vessels under nitrogen were filled with test solution.
- The vessels were placed in a temperature controlled environment.
- Blank buffers containing a similar content of co-solvent were treated similarly as the test samples.
SAMPLING DETAILS
- Samples for analysis were taken immediately after preparation (t=0).
- Samples for analysis (except for the blanks) were taken after 5 days (Tier 1) or at several sampling points after t=0 (Tier 2).
- Samples taken from solutions with a temperature > 20°C were cooled to room temperature using running tap water.
pH MEASUREMENTS
The pH of the test solutions (except for the blanks) was determined at least at the beginning and at the end of each test. - Buffers:
- - Buffer pH 4: aqueous solution of 16.7% 0.1 M sodium acetate and 83.3% 0.1 M acetic acid. Sodium azide content: 0.0009% (w/v).
- Buffer pH 7: aqueous solution of 0.1 M potassium di-hydrogenphosphate adjusted to pH 7 using 10 N sodium hydroxide. Sodium azide content: 0.0009% (w/v).
- Buffer pH 9: aqueous solution of 0.1 M boric acid and 0.1 M potassium chloride adjusted to pH 9 using 10 N sodium hydroxide. Sodium azide content: 0.0009% (w/v). - Details on test conditions:
- TEST SYSTEM
- Sterilisation method: Each buffer was filter-sterilised through a 0.2 µm FP 30/0.2 CA-S filter (Whatman) and transferred into a sterile vessel.
- Measures to exclude oxygen: nitrogen gas was purged through the sterile buffers for 5 minutes.
- Measures taken to avoid photolytic effects: the test vessels were kept in the dark.
- The samples not analysed on the sampling day were stored in the freezer for max. 13 days (stability has been demonstrated over this period). On the day of analysis, the frozen samples were defrosted at room temperature, treated and analysed.
TEST MEDIUM
- Kind of water used for the buffers: tap water purified by a purification system (Milli-Q, Millipore)
- Identity and concentration of co-solvent: acetonitrile. The volume of the co-solvent was < 1% of the sample volume. The nominal concentrations were not corrected for this.
ACTUAL TEMPERATURES
Tier 1
pH 4, 7 and 9: 49.3°C ± 0.7°C
Tier 2
pH 4: 19.8°C ± 0.1°C, 30.1°C ± 0.1°C and 50.1°C ± 0.1°C
pH 7: 19.7°C ± 0.5°C, 49.6°C ± 0.5°C and 59.9°C ± 0.1°C - Duration:
- 24.23 h
- pH:
- 4
- Temp.:
- 20 °C
- Initial conc. measured:
- 9.83 mg/L
- Remarks:
- mean (n=2) conc.
- Duration:
- 4.33 h
- pH:
- 4
- Temp.:
- 30 °C
- Initial conc. measured:
- 9.93 mg/L
- Remarks:
- mean (n=2) conc.
- Duration:
- 2.42 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 10.6 mg/L
- Remarks:
- mean (n=2) conc.
- Duration:
- 720.98 h
- pH:
- 7
- Temp.:
- 20 °C
- Initial conc. measured:
- 10.6 mg/L
- Remarks:
- mean (n=2) conc.
- Duration:
- 332.33 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 10.45 mg/L
- Remarks:
- mean (n=2) conc.
- Duration:
- 167.63 h
- pH:
- 7
- Temp.:
- 60 °C
- Initial conc. measured:
- 10.8 mg/L
- Remarks:
- mean (n=2) conc.
- Number of replicates:
- Two
- Positive controls:
- no
- Negative controls:
- no
- Preliminary study:
- At pH 4 and pH 7, a degree of hydrolysis of > 10% (100% and 64%, respectively) was observed after 5 days at 50°C. According to the guideline, the higher tier test was required.
At pH 9, hydrolysis of < 10% (6.2%) was observed after 5 days at 50°C (half-life time at 25°C is > 1 year). No further tests were required. - Test performance:
- RECOVERIES
- Recovery is the concentration analysed at t=0 relative to the nominal concentration.
- The mean (n=2) recovery at each pH and temperature was calculated (see table below).
- The mean recoveries fell within the criterion range of 90-110% (98-106% at pH 4 test and 105-108% at pH 7 test).
- The concentrations analysed in the test samples were not corrected for recovery. - Transformation products:
- not specified
- % Recovery:
- 98
- pH:
- 4
- Temp.:
- 20 °C
- Remarks on result:
- other: Tier 2
- % Recovery:
- 99
- pH:
- 4
- Temp.:
- 30 °C
- Remarks on result:
- other: Tier 2
- % Recovery:
- 106
- pH:
- 4
- Temp.:
- 50 °C
- Remarks on result:
- other: Tier 2
- % Recovery:
- 106
- pH:
- 7
- Temp.:
- 20 °C
- Remarks on result:
- other: Tier 2
- % Recovery:
- 105
- pH:
- 7
- Temp.:
- 50 °C
- Remarks on result:
- other: Tier 2
- % Recovery:
- 108
- pH:
- 7
- Temp.:
- 60 °C
- Remarks on result:
- other: Tier 2
- % Recovery:
- 99
- pH:
- 4
- Temp.:
- 50 °C
- Remarks on result:
- other: Tier 1
- % Recovery:
- 100
- pH:
- 7
- Temp.:
- 50 °C
- Remarks on result:
- other: Tier 1
- % Recovery:
- 103
- pH:
- 9
- Temp.:
- 50 °C
- Remarks on result:
- other: Tier 1
- pH:
- 4
- Temp.:
- 20 °C
- Hydrolysis rate constant:
- 0.186 h-1
- DT50:
- 3.7 h
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 4
- Temp.:
- 30 °C
- Hydrolysis rate constant:
- 0.649 h-1
- DT50:
- 1.1 h
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 4
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- 5.86 h-1
- DT50:
- 0.12 h
- Type:
- (pseudo-)first order (= half-life)
- Key result
- pH:
- 4
- Temp.:
- 25 °C
- Hydrolysis rate constant:
- 0.35 h-1
- DT50:
- 2 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: calculated from the Arrhenius equation
- pH:
- 7
- Temp.:
- 20 °C
- Hydrolysis rate constant:
- 0 h-1
- DT50:
- 99 d
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 7
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- 0.008 h-1
- DT50:
- 89 h
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 7
- Temp.:
- 60 °C
- Hydrolysis rate constant:
- 0.021 h-1
- DT50:
- 33 h
- Type:
- (pseudo-)first order (= half-life)
- Key result
- pH:
- 7
- Temp.:
- 25 °C
- Hydrolysis rate constant:
- 0.001 h-1
- DT50:
- 55 d
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: calculated from the Arrhenius equation
- Key result
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Remarks on result:
- hydrolytically stable based on preliminary test
- Validity criteria fulfilled:
- yes
- Remarks:
- The mean recoveries fell within the criterion range of 90-110% (98-106% at pH 4 test and 105-108% at pH 7 test).
- Conclusions:
- The half-life time of the substance at 25°C at pH 4, pH 7 and pH 9 was determined to be 2.0 hours, 55 days and > 1 year, respectively.
- Executive summary:
The rate of hydrolysis of the substance at pH values normally found in the environment (pH 4-9) was determined in a GLP-compliant study according to OECD 111.
A degree of hydrolysis of < 10% was observed at pH 9 after 5 days at 50°C (tier 1). This corresponds with a half-life time at 25°C of > 1 year and the substance can be considered hydrolytically stable at pH 9.
Hydrolysis of > 10% was determined at pH 4 and pH 7 after 5 days and 50°C. Hydrolysis rates at 20, 30 and 50°C (pH 4) and at 20, 50 and 60°C (pH 7) were determined in a tier 2 study. The substance was shown to degrade by a pseudo-first order behaviour. Half-life times at 25°C were determined from the Arrhenius equation: 2.0 hours at pH 4 and 55 days at pH 7. This leads to the conclusion that Hyacinth body has a half-life of 55 days at an environmental pH of 7.
Reference
Table: Preliminary test (Tier 1) results
pH code |
Sampling time |
Analyzed concentration |
Degree of hydrolysis [%] |
pH |
|
Individual |
Mean |
||||
pH 4 |
0 hours |
9.89 |
|
|
4.0 |
|
|
9.92 |
|
|
4.0 |
|
5 days |
not detected |
100 |
100 |
4.0 |
|
|
not detected |
100 |
|
4.0 |
pH 7 |
0 hours |
10.0 |
|
|
7.0 |
|
|
10.0 |
|
|
7.0 |
|
5 days |
3.47 |
65 |
64 |
7.1 |
|
|
3.72 |
63 |
|
7.1 |
pH 9 |
0 hours |
10.3 |
|
|
9.0 |
|
|
10.3 |
|
|
9.0 |
|
5 days |
9.59 |
7.0 |
6.2 |
9.0 |
|
|
9.75 |
5.4 |
|
9.0 |
Description of key information
Hydrolysis: (OECD TG 111): DT50 is 55 days at pH 7. The substance is hydrolytically stable at pH 9 (half-life time at 25°C of > 1 year), hydrolytically unstable at pH 7 (half-life time at 25°C of 55 days) and hydrolytically unstable at pH 4 (half-life time at 25°C of 2.0 hours).
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 55 d
- at the temperature of:
- 25 °C
Additional information
The rate of hydrolysis of the substance at pH values normally found in the environment (pH 4-9) was determined in a GLP-compliant study according to OECD 111.
A degree of hydrolysis of < 10% was observed at pH 9 after 5 days at 50°C (tier 1). This corresponds with a half-life time at 25°C of > 1 year and the substance can be considered hydrolytically stable at pH 9.
Hydrolysis of > 10% was determined at pH 4 and pH 7 after 5 days and 50°C. Hydrolysis rates at 20, 30 and 50°C (pH 4) and at 20, 50 and 60°C (pH 7) were determined in a tier 2 study. The substance was shown to degrade by a pseudo-first order behaviour. Half-life times at 25°C were determined from the Arrhenius equation: 2.0 hours at pH 4 and 55 days at pH 7. This leads to the conclusion that Hyacinth body has a half-life of 55 days at an environmental pH of 7.
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