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EC number: 233-937-0 | CAS number: 10450-60-9
- 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:
- 06 April 2018 to 28 November 2018
- 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)
- 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
- Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- For each sampling time, duplicate sterile vessels under vacuum were filled with 6 mL test solution and placed in the dark in a temperature controlled environment at 50.0°C ± 0.1°C.
- Buffers:
- BUFFER SOLUTIONS
Acetate buffer pH 4, 0.01 M: Solution of 16.7 % 0.01 M sodium acetate in water and 83.3 % 0.01 M acetic acid in water. Buffer contained 0.0009 % (w/v) sodium azide.
Phosphate buffer pH 7, 0.01 M: Solution of 0.01 M potassium di-hydrogen-phosphate in water adjusted to pH 7 using 1N sodium hydroxide. Buffer contained 0.0009 % (w/v) sodium azide.
Borate buffer pH 9, 0.01 M: Solution of 0.01 M boric acid in water and 0.01 M potassium chloride in water adjusted to pH 9 using 1 N sodium hydroxide. Buffer contained 0.0009 % (w/v) sodium azide.
Hydrochloride acid/potassium chloride buffer pH 1.3, 0.1 M: Approximately 3.728 gram of potassium chloride and 5.6 mL of hydrochloric acid was added to 1 000 mL of water. - Details on test conditions:
- PRELIMINARY TEST - TIER 1
- The test material was spiked to the buffer solutions at a target concentration of 40 mg/L using a spiking solution in water. Each solution was filter-sterilised through a 0.2 µm FP 30/0.2 CA-S 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, duplicate sterile vessels under vacuum were filled with 6 mL test solution and placed in the dark in a temperature controlled environment at 50.0 °C ± 0.1 °C.
- The spiking volume was ≤ 1 % of the sample volume. Nominal concentrations were not corrected for the spiking volume.
- The concentration of the test material in the test samples was determined immediately after preparation (t=0) and after 5 days. The samples taken at t=5 days were cooled to room temperature using running tap water. Samples were transferred to a glass container and analysed.
- Blank buffer solutions containing a similar content of blank spiking solution were treated similarly as the test samples and analysed at t=0.
- The pH of each of the test solutions (except for the blanks) was determined at each sampling time. - Duration:
- 5 d
- pH:
- 4
- Temp.:
- 25 °C
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 25 °C
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 25 °C
- Number of replicates:
- Two
- Positive controls:
- no
- Negative controls:
- no
- Preliminary study:
- PRELIMINARY TEST - TIER 1
- At pH 4, pH 7 and pH 9, a degree of hydrolysis of < 10 % was observed after 5 days. It demonstrated that the half-life time of the test material at 25 °C is > 1 year. According to the guideline, no further tests were required.
- No test material was detected in the blank buffer pH 9 samples. A small response at the retention time of the test item was detected in one of the two blank buffer pH 7 samples, which was considered to be an instability of the baseline rather than test material. Small responses at the retention time of the test material were detected in the chromatograms of both blank buffer pH 4 samples. It is not considered to influence the study results since it is caused by a matrix component from the pH 4 buffer and, therefore, corrected for by the matrix matched calibration curve.
- The mean recoveries of the test material containing buffer solutions at t=0 did not fall within the criterion range of 90-110 % for buffer pH 4 and pH 9. This does not impact the study outcome since the deviation from the criterion is small and the degree of hydrolysis is expressed relative to the t=0 hour samples. - Transformation products:
- not measured
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the conditions of the test a degree of hydrolysis at each pH value of < 10 % was observed after 5 days. The half-life time of the test material at 25 °C is > 1 year. According to the guideline, performance of the main study (Tier 2) was not required.
- Executive summary:
The hydrolysis rate of the test material was assessed according to EC Guideline C.7., OECD Guideline 111 and EPA Guideline OPPTS 835.2120 in accordance with the principles of GLP at pH values normally found in the environment (pH 4-9).
The test material was spiked to the buffer solutions at a target concentration of 40 mg/L using a spiking solution in water, filter-sterilised and transferred into a sterile vessel. To exclude oxygen, nitrogen gas was purged through the solution for 5 minutes. For each sampling time, duplicate sterile vessels under vacuum were filled with 6 mL test solution and placed in the dark in a temperature controlled environment at 50.0 °C ± 0.1 °C.
The concentration of the test material in the test samples was determined immediately after preparation (t=0) and after 5 days. The samples taken at t=5 days were cooled to room temperature using running tap water. Samples were transferred to a glass container and analysed using HPLC.
No test material was detected in the blank buffer pH 9 samples. A small response at the retention time of the test material was detected in one of the two blank buffer pH 7 samples, which was considered to be an instability of the baseline rather than test material. Small responses at the retention time of the test material were detected in the chromatograms of both blank buffer pH 4 samples. It is not considered to influence the study results since it is caused by a matrix component from the pH 4 buffer and, therefore, corrected for by the matrix matched calibration curve.
At each pH value a degree of hydrolysis of < 10 % was observed after 5 days. According to the guideline, performance of the main study (Tier 2) was not required.
Under the conditions of the study the half-life time of the test material at 25 °C is > 1 year.
Reference
Preliminary Test: Hydrolysis of the Test Material at pH 4, pH 7 and pH 9
pH code |
Sampling time |
Analysed concentration |
Degree of hydrolysis |
pH |
|
Individual |
Mean |
||||
pH 4 |
0 hours |
44.9 |
|
|
4.0 |
|
45.1 |
|
|
4.0 |
|
5 days |
45.3 |
-0.60 |
0.14 |
4.1 |
|
|
44.6 |
0.88 |
|
4.1 |
|
pH 7 |
0 hours |
44.0 |
|
|
7.0 |
|
44.2 |
|
|
7.0 |
|
5 days |
43.8 |
0.78 |
0.49 |
7.0 |
|
|
44.1 |
0.21 |
|
7.0 |
|
pH 9 |
0 hours |
46.2 |
|
|
8.9 |
|
46.3 |
|
|
8.9 |
|
5 days |
46.9 |
-1.4 |
-1.3 |
9.0 |
|
|
46.8 |
-1.2 |
|
9.0 |
Preliminary Test: Recoveries
pH code |
Nominal concentration |
Analysed concentration |
Recovery |
|
Individual |
Mean |
|||
pH 4 |
40.0 |
44.9 |
112 |
113
|
40.0 |
45.1 |
113 |
||
pH 7 |
40.0 |
44.0 |
110 |
110
|
40.0 |
44.2 |
111 |
||
pH 9 |
40.0 |
46.2 |
116 |
116
|
40.0 |
46.3 |
116 |
Description of key information
Under the conditions of the test a degree of hydrolysis at each pH value of < 10 % was observed after 5 days. The half-life time of the test material at 25 °C is > 1 year. According to the guideline, performance of the main study (Tier 2) was not required.
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 1 yr
- at the temperature of:
- 25 °C
Additional information
The hydrolysis rate of the test material was assessed according to EC Guideline C.7., OECD Guideline 111 and EPA Guideline OPPTS 835.2120 in accordance with the principles of GLP at pH values normally found in the environment (pH 4-9). The study was assigned a reliability score of 1 in accordance with the principles for assessing data quality as outlined by Klimisch et al. (1997).
The test material was spiked to the buffer solutions at a target concentration of 40 mg/L using a spiking solution in water, filter-sterilised and transferred into a sterile vessel. To exclude oxygen, nitrogen gas was purged through the solution for 5 minutes. For each sampling time, duplicate sterile vessels under vacuum were filled with 6 mL test solution and placed in the dark in a temperature controlled environment at 50.0 °C ± 0.1 °C.
The concentration of the test material in the test samples was determined immediately after preparation (t=0) and after 5 days. The samples taken at t=5 days were cooled to room temperature using running tap water. Samples were transferred to a glass container and analysed using HPLC.
No test material was detected in the blank buffer pH 9 samples. A small response at the retention time of the test material was detected in one of the two blank buffer pH 7 samples, which was considered to be an instability of the baseline rather than test material. Small responses at the retention time of the test material were detected in the chromatograms of both blank buffer pH 4 samples. It is not considered to influence the study results since it is caused by a matrix component from the pH 4 buffer and, therefore, corrected for by the matrix matched calibration curve.
At each pH value a degree of hydrolysis of < 10 % was observed after 5 days. According to the guideline, performance of the main study (Tier 2) was not required.
Under the conditions of the study the half-life time of the test material at 25 °C is > 1 year.
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