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EC number: 866-700-0 | CAS number: 2102522-55-2
- 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:
- 13 June 2018 - 19 June 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Version / remarks:
- 13 April 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- - Storage conditions: The test material was stored in a dark storage place at room temperature.
- Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- - The concentration of the test material in the LC-MS analytical sample was calculated proportionally by comparing the peak area of the LC-MS analytical sample with that of 5.05 μg/L standard solution.
- Buffers:
- - pH 4.0: The solution was prepared by mixing 4.5 mL of 1 mol/L sodium hydroxide solution and 50 mL of 0.5 mol/L potassium dihydrogen citrate solution, and then filling up to 500 mL with purified water, and then adjusting to pH 4.0 with 1 mol/L hydrochloric acid.
- pH 7.0: The solution was prepared by mixing 14.8 mL of 1 mol/L sodium hydroxide solution and 50 mL of 0.5 mol/L potassium dihydrogenphosphate solution, filling up to 500 mL with purified water.
- pH 9.0: The solution was prepared by mixing 10.7 mL of 1 mol/L sodium hydroxide solution and 50 mL of 0.5 mol/L potassium chloride and 0.5 mol/L boric acid solution, filling up to 500 mL with purified water, and then adjusting to pH 9.0 with 1 mol/L sodium hydroxide solution. - Details on test conditions:
- TEST SYSTEM
- Dry thermobath: MG-1 (Tokyo Rikakikai Co. Ltd.)
- Test vessel: 10 mL test tube with ground stopper (test vessels were covered with aluminium foil).
TEST CONDITIONS
- Measurement point: At initiation and after 5 days (at each pH).
- Light condition: Light free conditions
PREPARATION OF TEST MATERIAL SOLUTION
- The test sample (10.35 mg, corresponding to 10.11 mg of the test material) was precisely weighed and put into a 20 mL volumetric flask, and then dissolved and filled up in acetonitrile to obtain 505 mg/L solution of the test material.
- An aliquot (1 mL) of the solution of the test material was pipetted into a 10 mL volumetric flask and filled up with acetonitrile to prepare a 50.5 mg/L solution of the test material.
- An aliquot (1 mL) of the solution of the test material was pipetted into a 50 mL volumetric flask and filled up with acetonitrile to prepare a 1.01 mg/L solution of the test material.
PREPARATION FOR STANDARD SOLUTION AND CALCULATION OF CONCENTRATION
- The test material solution (505 mg/L) was then diluted with acetonitrile/purified water (1/1 v/v) to prepare a 5.05 μg/L standard solution.
CALCULATION FOR RESIDUAL PERCENTAGE OF TEST MATERIAL
- The residual percentage of the test material was calculated using the following equation:
Residual percentage of test material (%) = (C/Ci) x 100
Where:
Ci: Concentration of test material at initiation (μg/L)
C: Concentration of test material after 5 days (μg/L)
The test material was judged to be hydrolytically stable in case that the residual percentage of the test material was > 90 %. - Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 9.21 µg/L
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 8.55 µg/L
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 7.51 µg/L
- Number of replicates:
- 1 analysis at initiation, duplicate analyses at 5 days.
- Positive controls:
- not specified
- Negative controls:
- not specified
- Test performance:
- At pH 4.0 the concentration at initiation was 9.21 μg/L, after 5 days this was 8.80 and 9.67 per replicate. The average residual percentage after 5 days was 100 %.
At pH 7.0 the concentration at initiation was 8.55 μg/L, after 5 days this was 8.54 and 8.82 per replicate. The average residual percentage after 5 days was 101 %.
At pH 9.0 the concentration at initiation was 7.51 μg/L, after 5 days this was 7.56 and 7.13 per replicate. The average residual percentage after 5 days was 97.9 %.
As the results of residual percentage of the test material were larger than 90 %, the test material was considered to be hydrolytically stable at pH 4.0, 7.0 and 9.0. - Transformation products:
- not measured
- % Recovery:
- 100
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- 101
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- 97.9
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 4
- Temp.:
- 50 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 7
- Temp.:
- 50 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 9
- Temp.:
- 50 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the conditions of the study the test material is hydrolytically stable at pH 4.0, 7.0 and 9.0.
- Executive summary:
The hydrolytic properties of the test material were assessed using a HPLC method, in accordance with the standardised guidelines OECD 111, under GLP conditions.
The preliminary test (Tier 1) was performed using three buffer solutions at pH 4.0, 7.0 and 9.0. The test material concentrations after 5 days were measured by LC-MS. The test material concentration was determined by the absolute calibration curve method using one concentration of the standard solution, after which the residual percentage of the test material was calculated. As a result, the residual percentage of the test material was larger than 90 %, therefore, under the conditions of the study the test material is hydrolytically stable at pH 4.0, 7.0 and 9.0.
Reference
Summary of results
Test solution |
Concentration (μg/L |
Residual percentage after 5 days (%) |
||
At initiation |
After 5 days |
Measured Value |
Average |
|
pH 4.0 |
9.21 |
8.80 9.67 |
95.5 105 |
100 |
pH 7.0 |
8.55 |
8.54 8.82 |
99.8 103 |
101 |
pH 9.0 |
7.51 |
7.56 7.13 |
101 94.9 |
97.9 |
Description of key information
The test material is hydrolytically stable at pH 4.0, 7.0 and 9.0.
Key value for chemical safety assessment
Additional information
The hydrolytic properties of the test material were assessed using a HPLC method, in accordance with the standardised guidelines OECD 111, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
The preliminary test (Tier 1) was performed using three buffer solutions at pH 4.0, 7.0 and 9.0. The test material concentrations after 5 days were measured by LC-MS. The test material concentration was determined by the absolute calibration curve method using one concentration of the standard solution, after which the residual percentage of the test material was calculated. As a result, the residual percentage of the test material was larger than 90 %, therefore, under the conditions of the study the test material is hydrolytically stable at pH 4.0, 7.0 and 9.0.
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