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EC number: 473-810-9 | 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:
- 10 November 2005 to 24 November 2005
- 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:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products: A sample of the prepared solution was analysed in duplicate after a 500-fold dilution in mobile phase in order to determine the initial concentration of the test material. Following heating, the concentration of the test material in the solution was determined in duplicate, after 2.4 hours and 5 days.
- Sampling intervals/times for pH measurements: For each sampling time the pH value of the solutions was measured.
- Other observation, if any (e.g.: precipitation, colour change etc.): For each sampling time the the visual appearance of the solutions was noted. - Buffers:
- Buffer solutions at pH 4.0, 7.0 and 9.0 were prepared. The pH of each buffer solution was checked before use. Each buffer solution was degassed (5 mins, sonicate) to ensure sterility
- Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: An aliquot of test material (50.041 mg for pH = 4.0, 49.840 mg for pH 7.0 and 50.427 mg for pH= 9.0) was introduced in a volumetric flask (50 mL) and each flask was made to volume with buffer.
- Lighting:The determination was performed in vessels protected from light.
- Stability of test material: The solutions were placed in an oven at approximately +50 °C (temperature was recorded during the test) for up to 5 days. - Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 985 mg/L
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 1 010 mg/L
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 1 010 mg/L
- Number of replicates:
- One flask per pH
- Positive controls:
- no
- Negative controls:
- no
- Preliminary study:
- No significant variation of pH was observed for any buffer at any time. At each pH, resulting solutions at the end of the test were colourless. The degradation of the test material at each pH value indicated hydrolysis lower than 10 % after 5 days.
- Test performance:
- In agreement with the guideline, the test was considered complete after the performance of the preliminary test revealed the test material to be hydrolytically stable.
- Transformation products:
- no
- % Recovery:
- 104
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- 102
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- 103
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 4
- Temp.:
- 50 °C
- DT50:
- > 1 yr
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 7
- Temp.:
- 50 °C
- DT50:
- > 1 yr
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 9
- Temp.:
- 50 °C
- DT50:
- > 1 yr
- Remarks on result:
- hydrolytically stable based on preliminary test
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the conditions of this study, the test material can be considered as a hydrolytically stable compound and its t1/2 at +25 °C was considered to be greater than 1 year.
- Executive summary:
The abiotic degradation (hydrolysis as a function of pH) of the test material was determined in accordance with the standardised guideline EU Method C.7 under GLP conditions.
The abiotic degradation of the test material was estimated in a preliminary test. The determination was undertaken at three pH levels (pH 4.0, 7.0 and 9.0). The test was performed at 50.0 ± 1 °C under sterile conditions and protected from light. The solutions were analysed by High Performance Liquid Chromatography with Ultra-Violet detection at the start of the test and after 2.4 hours and 5 days.
The degradation of the test material, at each pH value, indicated hydrolysis lower than 10 % after 5 days. In agreement with the guideline, the test was considered complete.
Under the conditions of this study, the test material can be considered as a hydrolytically stable compound and its t1/2 at +25 °C was considered to be greater than 1 year.
Reference
Table 1: Summary of Preliminary Test Results at 50 °C
Sampling Time (hours) |
Measured pH |
Measured Concentration (mg/L) |
|||
First Assay |
Second assay |
Mean |
Remaining Concentration (%)* |
||
0 |
3.98 |
1020 |
949 |
985 |
100 |
2.4 |
3.99 |
1020 |
1030 |
1030 |
105 |
120 |
3.96 |
1020 |
1010 |
1020 |
104 |
0 |
7.00 |
1040 |
976 |
1010 |
100 |
2.4 |
6.97 |
1000 |
991 |
996 |
98.6 |
120 |
6.94 |
1030 |
1030 |
1030 |
102 |
0 |
8.94 |
1020 |
1000 |
1010 |
100 |
2.4 |
8.83 |
1030 |
1050 |
1040 |
103 |
120 |
8.34 |
1050 |
1030 |
1040 |
103 |
*Calculated using the mean value of T = 0 hour
Description of key information
Under the conditions of this study, the test material can be considered as a hydrolytically stable compound and its t1/2 at +25 °C was considered to be greater than 1 year.
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 1 yr
- at the temperature of:
- 25 °C
Additional information
The abiotic degradation (hydrolysis as a function of pH) of the test material was determined in accordance with the standardised guideline EU Method C.7 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 abiotic degradation of the test material was estimated in a preliminary test. The determination was undertaken at three pH levels (pH 4.0, 7.0 and 9.0). The test was performed at 50.0 ± 1 °C under sterile conditions and protected from light. The solutions were analysed by High Performance Liquid Chromatography with Ultra-Violet detection at the start of the test and after 2.4 hours and 5 days.
The degradation of the test material, at each pH value, indicated hydrolysis lower than 10 % after 5 days. In agreement with the guideline, the test was considered complete.
Under the conditions of this study, the test material can be considered as a hydrolytically stable compound and its t1/2 at +25 °C was considered to be greater than 1 year.
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