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EC number: - | CAS number: -
- 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:
- 29 June 2017 - 07 November 2017
- 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:
- 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
- Details on sampling:
- The concentration of the test item 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.
- Buffers:
- - Acetate buffer pH 4, 0.1 M: Solution of 16.7% 0.1 M sodium acetate in water and 83.3% 0.1 M acetic acid in water. Buffer contained 0.0009% (w/v) sodium azide.
- Phosphate buffer pH 7, 0.1 M: Solution of 0.1 M potassium di-hydrogen-phosphate in water adjusted to pH 7 using 10N sodium hydroxide. Buffer contained 0.0009% (w/v) sodium azide.
- Borate buffer pH 9, 0.1 M: Solution of 0.1 M boric acid in water and 0.1 M potassium chloride in water adjusted to pH 9 using 10N sodium hydroxide. Buffer contained 0.0009% (w/v) sodium azide - Details on test conditions:
- PRELIMINARY TEST - TIER 1
The buffer solutions were 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. The test item was spiked to the solutions at a target concentration of 40 mg/L using a spiking solution in 50/50 (v/v) THF/water. 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 49.9°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 item 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.
Analysis was performed on subsamples of 500 µL. The samples were diluted in a 1:1 (v:v) ratio with THF and analyzed. The blank buffer solutions were diluted in a 1:1 (v:v) ratio with THF and analyzed.
Blank buffer solutions containing a similar content of blank spiking solution were treated similarly as the test samples and analyzed 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.:
- 50 °C
- Initial conc. measured:
- ca. 40.1 mg/L
- Remarks:
- peak 1
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 40 mg/L
- Remarks:
- peak 1
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 39.4 mg/L
- Remarks:
- peak 1
- Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 39.8 mg/L
- Remarks:
- peak 2
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 40 mg/L
- Remarks:
- peak 2
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 41.8 mg/L
- Remarks:
- peak 2
- Number of replicates:
- Two
- Positive controls:
- no
- Negative controls:
- yes
- Remarks:
- Blank buffer solutions containing a similar content of blank spiking solution were treated similarly as the test samples and analyzed at t=0.
- Preliminary study:
- PEAK 1
- At pH 4, pH 7, and pH 9, a degree of hydrolysis of < 10% was observed after 5 days at 50°C. It demonstrated that the half-life time of the test item at 25°C is > 1 year.
According to the guideline, no further tests were required.
PEAK 2
- At pH 4, and pH 9, a degree of hydrolysis of < 10% was observed after 5 days at 50°C. It demonstrated that the half-life time of the test item at 25°C is > 1 year.
According to the guideline, no further tests were required.
- At pH 7, a degree of hydrolysis of > 10% was observed after 5 days. Since hydrolysis is not observed at pH 4 and pH 9, hydrolysis is not expected at pH 7. A possible explanation might be a limited solubility since at pH 7 later eluting peaks also have a lower response.
Based on this, it was decided not to perform the main study at pH 7 based on peak 2. - Test performance:
- RECOVERY
PEAK 1
No test item was detected in the blank buffer solutions.
The mean recoveries of the of the test item containing buffer solutions at t=0 fell within the criterion range of 90-110%.
It demonstrated that the analytical method was adequate to support the hydrolysis study on the test item.
PEAK 2
No test item was detected in the blank buffer solutions.
The mean recoveries of the of the test item containing buffer solutions at t=0 fell within the criterion range of 90-110%.
It demonstrated that the analytical method was adequate to support the hydrolysis study on the test item. - Transformation products:
- not measured
- % Recovery:
- 100
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- other: peak1
- % Recovery:
- 100
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- other: peak 1
- % Recovery:
- 99
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- other: peak 1
- % Recovery:
- 99
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- other: peak 2
- % Recovery:
- 100
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- other: peak 2
- % Recovery:
- 105
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- other: peak 2
- Key result
- pH:
- 4
- Temp.:
- 50 °C
- DT50:
- > 1 yr
- Type:
- not specified
- Remarks on result:
- other: peak 1
- Key result
- pH:
- 7
- Temp.:
- 50 °C
- DT50:
- > 1 yr
- Type:
- not specified
- Remarks on result:
- other: peak 1
- Key result
- pH:
- 9
- Temp.:
- 50 °C
- DT50:
- > 1 yr
- Type:
- not specified
- Remarks on result:
- other: peak 1
- Key result
- pH:
- 4
- Temp.:
- 50 °C
- DT50:
- > 1 yr
- Type:
- not specified
- Remarks on result:
- other: peak 2
- Key result
- pH:
- 7
- Temp.:
- 50 °C
- DT50:
- > 1 yr
- Type:
- not specified
- Remarks on result:
- other: peak 2
- Remarks:
- expected result
- Key result
- pH:
- 9
- Temp.:
- 50 °C
- DT50:
- > 1 yr
- Type:
- not specified
- Remarks on result:
- other: peak 2
- Details on results:
- At pH 7, a degree of hydrolysis of > 10% was observed after 5 days at 50°C for peak 2. Since hydrolysis is not observed at pH 4 and pH 9, hydrolysis is not expected at pH 7. A possible explanation might be a limited solubility since at pH 7 later eluting peaks also have a lower response. Based on this, it was decided not to perform the main study at pH 7 based on peak 2.
- Validity criteria fulfilled:
- yes
- Remarks:
- It demonstrated that the analytical method was adequate to support the hydrolysis study on the test item
- Conclusions:
- The rate of the hydrolysis of the test item was determined according to OECD Guideline No 111, EC Guideline No. C.7, EPA OPPTS 835.2120.
A preliminary test (Tier 1) was performed at pH values normally found in the environment (pH 4 - 7 - 9). The degree of hydrolysis was determined after 5 days at 50°C. The quantification was based on the two major peaks in the chromatogram.
It demonstrated that the half-life time of peak 1 at 25°C is > 1 year, at all the three values of pH. It demonstrated that the half-life time of peak 2 at 25°C is > 1 year at pH 4 and 9. It is expected to be > 1 year at 25°C also at pH 7.
According to the guideline, performance of the main study (Tier 2) was not required. - Executive summary:
The rate of the hydrolysis of the test item was determined according to OECD Guideline No 111, EC Guideline No. C.7, EPA OPPTS 835.2120 and GLP principles.
A preliminary test (Tier 1) was performed at pH values normally found in the environment (pH 4 - 7 - 9). The quantification was based on the two major peaks in the chromatogram.
Based on peak 1, at each pH value a degree of hydrolysis of < 10% was observed after 5 days at 50°C. It demonstrated that the half-life time of the test item at 25°C is > 1 year. According to the guideline, performance of the main study (Tier 2) was not required.
Based on peak 2, at pH 4, and pH 9, a degree of hydrolysis of < 10% was observed after 5 days at 50°C. It demonstrated that the half-life time of the test item at 25°C is > 1 year. According to the guideline, no further tests were required. At pH 7, a degree of hydrolysis of > 10% was observed after 5 days at 50°C. Since hydrolysis was not observed at pH 4 and pH 9, hydrolysis was not expected at pH 7. A possible explanation might be a limited solubility since at pH 7 later eluting peaks also have a lower response. Based on this, it was decided not to perform the main study at pH 7 based on peak 2.
Reference
Preliminary Test: Hydrolysis of the Test Item at pH 4, pH 7 and pH 9 – Based on peak 1
pH code |
Sampling time |
Analyzed concentration |
Degree of hydrolysis |
pH |
|
Individual |
Mean |
||||
pH 4 |
0 hours |
40.1 |
|
|
3.9 |
|
|
40.1 |
|
|
4.0 |
|
5 days |
39.7 |
1.1 |
1.1 |
4.0 |
|
|
39.7 |
1.1 |
|
4.0 |
pH 7 |
0 hours |
39.7 |
|
|
7.1 |
|
|
40.2 |
|
|
7.1 |
|
5 days |
38.6 |
3.3 |
2.6 |
7.0 |
|
|
39.2 |
2.0 |
|
7.1 |
pH 9 |
0 hours |
39.6 |
|
|
9.1 |
|
|
39.3 |
|
|
9.1 |
|
5 days |
40.3 |
-2.2 |
-1.9 |
9.1 |
|
|
40.1 |
-1.7 |
|
9.1 |
Preliminary Test: Hydrolysis of the Test Item at pH 4, pH 7 and pH 9 – Based on peak 2
pH code |
Sampling time |
Analyzed concentration |
Degree of hydrolysis |
pH |
|
Individual |
Mean |
||||
pH 4 |
0 hours |
40.5 |
|
|
3.9 |
|
|
39.0 |
|
|
4.0 |
|
5 days |
37.9 |
4.7 |
4.7 |
4.0 |
|
|
37.8 |
4.8 |
|
4.0 |
pH 7 |
0 hours |
39.9 |
|
|
7.1 |
|
|
40.2 |
|
|
7.1 |
|
5 days |
31.4 |
22 |
21 |
7.0 |
|
|
31.7 |
21 |
|
7.1 |
pH 9 |
0 hours |
43.8 |
|
|
9.1 |
|
|
39.9 |
|
|
9.1 |
|
5 days |
37.8 |
9.6 |
8.2 |
9.1 |
|
|
39.0 |
6.9 |
|
9.1 |
Preliminary Test: Recoveries –Based on peak 1
pH code |
Nominal concentration |
Analyzed concentration |
Recovery |
|
Individual |
Mean |
|||
pH 4 |
40.0 |
40.1 |
100 |
100 |
|
40.0 |
40.1 |
100 |
|
pH 7 |
40.0 |
39.7 |
99 |
100 |
|
40.0 |
40.2 |
100 |
|
pH 9 |
40.0 |
39.6 |
99 |
99 |
|
40.0 |
39.3 |
98 |
|
Preliminary Test: Recoveries – Based on peak 2
pH code |
Nominal concentration |
Analyzed concentration |
Recovery |
|
Individual |
Mean |
|||
pH 4 |
40.0 |
40.5 |
101 |
99 |
|
40.0 |
39.0 |
97 |
|
pH 7 |
40.0 |
39.9 |
100 |
100 |
|
40.0 |
40.2 |
101 |
|
pH 9 |
40.0 |
43.8 |
109 |
105 |
|
40.0 |
39.9 |
100 |
|
Description of key information
The objective of this study was the determination of the rate of the hydrolysis of the test item, according to OECD Guideline No 111,EC Guideline No. C.7, EPA OPPTS 835.2120 and GLP principles.
A preliminary test (Tier 1) was performed at pH values normally found in the environment (pH 4 - 7 - 9). The quantification was based on the two major peaks in the chromatogram.
Based on peak 1, at each pH value a degree of hydrolysis of < 10% was observed after 5 days at 50°C. It demonstrated that the half-life time of the test item at 25°C is > 1 year. According to the guideline, performance of the main study (Tier 2) was not required.
Based on peak 2, at pH 4, and pH 9, a degree of hydrolysis of < 10% was observed after 5 days at 50°C. It demonstrated that the half-life time of the test item at 25°C is > 1 year. According to the guideline, no further tests were required.
At pH 7, a degree of hydrolysis of > 10% was observed after 5 days at 50°C. Since hydrolysis was not observed at pH 4 and pH 9, hydrolysis was not expected at pH 7. A possible explanation might be a limited solubility since at pH 7 later eluting peaks also have a lower response. Based on this, it was decided not to perform the main study at pH 7 based on peak 2.
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 1 yr
- at the temperature of:
- 25 °C
Additional information
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Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.