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EC number: 629-080-0 | CAS number: 161308-34-5
- 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:
- 15 May 2019 - 20 May 2019
- 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:
- 2016
- 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 (incl. QA statement)
- Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- PREPARATION OF THE TEST SOLUTIONS
- Test item was spiked to sterile buffers using a test item solution in tap water purified by a Milli-Q water purification system (Millipore, USA)
- Target concentration: 1 mg/L
- Each solution was filter-sterilised through a 0.2 μm FP 30/0.2 CAS filter (Whatman, Dassel, Germany) and transferred into a sterile vessel. To exclude oxygen, nitrogen gas was purged through the solution for 5 minutes.
- For each sampling time (see below), duplicate sterile vessels under vacuum were filled with 6 mL test solution.
- Blank buffers containing a similar content of blank spiking solution were treated similarly as the test samples taken at t=0.
- The vessels were placed in a temperature controlled environment in the dark at 50.1°C +/- 0.2°C.
SAMPLING DETAILS
- Samples for analysis were taken immediately after preparation (t=0), at t= 2.4 hours and at t= 5 days.
- Samples taken at t=2.4 h and 5 days were cooled to room temperature using running tap water.
DETAILS ON PRETREATMENT PRIOR TO ANALYSIS
Analysis was performed on subsamples of 40 μL. The samples were 25-fold diluted with buffer and analyzed.
pH MEASUREMENTS
The pH of the test solutions (except for the blanks) was determined at each sampling point. - Buffers:
- - Buffer pH 4: Solution of 16.7% 0.01 M sodium acetate and 83.3% 0.01 M acetic acid in water.
- Buffer pH 7: Solution of 0.01 M potassium di-hydrogenphosphate in water adjusted to pH 7 using 1 N sodium hydroxide.
- Buffer pH 9: Solution of 0.01 M boric acid and 0.01 M potassium chloride in water adjusted to pH 9 using 1 N sodium hydroxide.
Details:
- Kind of water: tap water purified by a purification system (Milli-Q, Millipore)
- Sodium azide content all buffers: 0.0009% (w/v) - Details on test conditions:
- TEST SYSTEM
- Measures to exclude oxygen: nitrogen gas was purged through the solutions for 5 minutes (see above)
- Measures taken to avoid photolytic effects: the test vessels were kept in the dark.
CO-SOLVENT
- The volume of the co-solvent was < 1% of the sample volume. Nominal concentrations were not corrected for the spiking volume.
DETAILS TIER 1
- pH 4.0 at 50.1 ± 0.2°C
- pH 7.0 at 50.1 ± 0.2°C
- pH 9.0 at 50.1 ± 0.2°C - Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 1 mg/L
- Remarks:
- Initial conc. measured: see table in Results.
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 1 mg/L
- Remarks:
- Initial conc. measured: see table in Results.
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 1 mg/L
- Remarks:
- Initial conc. measured: see table in Results.
- Number of replicates:
- Two
- Positive controls:
- no
- Negative controls:
- no
- Preliminary study:
- At pH 4, pH 7 and pH 9 a decrease of substance concentration of < 10% was observed after 5 days.
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 was calculated (see table below).
- The mean recoveries fell within the criterion range of 90-110% for pH 4 and pH 7.
- The mean recoveries fell within the acceptable range of 70-110% for pH 9. - Transformation products:
- no
- Details on hydrolysis and appearance of transformation product(s):
- not applicable
- % Recovery:
- 99
- pH:
- 4
- Temp.:
- 50 °C
- % Recovery:
- 96
- pH:
- 7
- Temp.:
- 50 °C
- % Recovery:
- 84
- pH:
- 9
- Temp.:
- 50 °C
- Key result
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Remarks on result:
- hydrolytically stable based on preliminary test
- Details on results:
- The preliminary study indicated that the substance is hydrolytically stable at pH 4, pH 7 and pH 9 (half-life time at 25°C is > 1 year) and no further study was performed.
- Conclusions:
- The substance is hydrolytically stable at pH 4, 7 and 9 (half-life time at 25°C of > 1 year).
- Executive summary:
Hydrolysis of the substance at pH values normally found in the environment (pH 4, 7 and 9) was investigated in a GLP-compliant study according to EC C.7, OECD 111 and EPA OPPTS 835.2120. A degree of < 10% of hydrolysis was observed at pH 4, 7 and 9 after 5 days at 50°C (Tier 1). This corresponds with a half-life time at 25°C of > 1 year. The substance is concluded to be hydrolytically stable at pH 4, 7 and 9.
Reference
Table: Tier 1 results at pH 4, pH 7 and pH 9 and 50°C
pH |
Sampling time |
Analyzed concentration [mg/L] |
Degree of hydrolysis [%] |
Measured pH |
|
Individual |
Mean |
||||
4 |
0 hours |
0.991 |
|
|
4.1 |
|
0.992 |
|
|
4.1 |
|
2.4 hours |
0.992 |
0.0063 |
-0.11 |
4.1 |
|
|
0.994 |
-0.22 |
|
4.1 |
|
5 days |
0.988 |
0.41 |
0.26 |
4.1 |
|
|
0.991 |
0.11 |
|
4.1 |
|
7 |
0 hours |
0.957 |
|
|
7.0 |
|
0.957 |
|
|
7.1 |
|
2.4 hours |
0.952 |
0.52 |
1.0 |
7.1 |
|
|
0.942 |
1.5 |
|
7.1 |
|
5 days |
0.958 |
-0.15 |
-0.13 |
7.0 |
|
|
0.958 |
-0.12 |
|
7.0 |
|
9 |
0 hours |
0.843 |
|
|
9.1 |
|
0.835 |
|
|
9.1 |
|
2.4 hours |
0.843 |
-0.50 |
-0.22 |
9.1 |
|
|
0.838 |
0.056 |
|
9.1 |
|
5 days |
0.940 |
-12 |
-12 |
9.0 |
|
|
0.934 |
-11 |
|
9.0 |
Description of key information
The substance is hydrolytically stable at pH values normally found in the environment (pH 4 - 9).
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 1 yr
- at the temperature of:
- 25 °C
Additional information
Hydrolysis of the substance at pH values normally found in the environment (pH 4, 7 and 9) was investigated in a GLP-compliant study according to EC C.7, OECD 111 and EPA OPPTS 835.2120. A degree of < 10% of hydrolysis was observed at pH 4, 7 and 9 after 5 days at 50°C (Tier 1). This corresponds with a half-life time at 25°C of > 1 year. The substance is concluded to be hydrolytically stable at pH 4, 7 and 9.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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