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EC number: 926-126-4 | 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:
- 16 November 2016 to 13 December 2016
- 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- SAMPLING
- Duplicate sample solutions were taken initially and from the water bath at various time points.
- The pH of each solution was recorded. - Buffers:
- TEST SYSTEM
- The test system consisted of buffer solutions at pH’s 4, 7 and 9 (see Table 1, below).
- The buffer solutions were passed through a 0.2 μm membrane filter to sterilise and subjected to ultrasonication and degassing with nitrogen to minimise dissolved oxygen. - Details on test conditions:
- PREPARATION OF TEST SOLUTIONS
- Stock solutions of test item were prepared at a nominal concentration of 1.0 x 10E03 mg/L in the three buffer solutions. At this concentration the pH 4 stock precipitated. It was therefore passed through a filter paper and the filtrate diluted by a factor of 2 with the pH 4 buffer solution. This produced a stock solution than was half saturation as required by the test guidelines.
- The stock solutions were split into individual glass vessels, sealed with minimal headspace, for each data point. These sample solutions were shielded from light whilst maintained at the test temperature.
PRELIMINARY TEST / TIER 1
- Sample solutions at pH 4, 7 and 9 were maintained at 50.0 ± 0.5 °C for a period of 120 hours.
EVALUATION OF DATA
- The response factors of the standard peak areas (unit peak area per mg/L) were calculated using the equation RFstd = Rstd / Cstd where RFstd = response factor of the standard solution; Rstd = peak area of the standard solution; Cstd = concentration of the standard solution (mg/L).
- Each sample solution concentration (mg/L) was calculated using the equation C = (Rspl / RFstd) * D where C = sample solution concentration (mg/L); Rspl = mean peak area of the sample solution; RFstd = mean response factor of the standard solutions (unit peak area per mg/L); D = dilution factor (0.05 for pH 4 samples only to account for injection volume).
DEGREE OF HYDROLYSIS
- The decrease in concentration as a percentage of initial concentration was calculated using the equation Percentage of initial = (Ct / C0) * 100 where Ct = concentration of the test solution at time t (g/L); C0 = concentration of the test solution at time 0 (g/L). - Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 0.001 mg/L
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 0.001 mg/L
- Duration:
- 120 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 0.001 mg/L
- Number of replicates:
- Two
- Positive controls:
- no
- Negative controls:
- no
- Transformation products:
- no
- Key result
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Remarks on result:
- other: < 10% hydrolysis after 5 days at 50 °C (equivalent to half-life > 1 yr at 25 °C)
- Key result
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Remarks on result:
- other: < 10% hydrolysis after 5 days at 50 °C (equivalent to half-life > 1 yr at 25 °C)
- Key result
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Remarks on result:
- other: < 10% hydrolysis after 5 days at 50 °C (equivalent to half-life > 1 yr at 25 °C)
- Details on results:
- RESULTS
- Typical chromatography is presented in Appendix 1 (attached).
- The mean peak areas relating to the standard and sample solutions are shown in Table 2 (attached).
- Test item concentrations at given time points are shown Tables 3, 4 and 5 (attached).
- Result for pH 4 at 50 °C: Less than 10% hydrolysis after 5 days at 50 °C, equivalent to a half-life greater than 1 year at 25 °C.
- Result for pH 7 at 50 °C: Less than 10% hydrolysis after 5 days at 50 °C, equivalent to a half-life greater than 1 year at 25 °C.
- Results for pH 9 at 50 °C: Less than 10% hydrolysis after 5 days at 50 °C, equivalent to a half-life greater than 1 year at 25 °C. - Validity criteria fulfilled:
- yes
- Conclusions:
- The estimated half-life at 25 °C of the test item was shown to be greater than 1 year at pH 4, 7 and 9.
- Executive summary:
GUIDELINE
Assessment of hydrolytic stability was carried out using Method C.7 Abiotic Degradation, Hydrolysis as a Function of pH of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 111 of the OECD Guidelines for Testing of Chemicals, 13 April 2004.
METHODS
The test system consisted of buffer solutions at pH 4, 7 and 9. The buffer solutions were passed through a 0.2 μm membrane filter to sterilise and subjected to ultrasonication and degassing with nitrogen to minimise dissolved oxygen. Duplicate sample solutions were taken initially and from the water bath at various time points. The pH of each solution recorded. The concentration of test item in the sample solutions was determined by high performance liquid chromatography (HPLC).
Stock solutions of test item were prepared at a nominal concentration of 1.0 x10E03 mg/L in the three buffer solutions. At this concentration the pH 4 stock precipitated. It was therefore passed through a filter paper and the filtrate diluted by a factor of 2 with the pH 4 buffer solution. This produced a stock solution than was half saturation as required by the test guidelines.
The stock solutions were split into individual glass vessels, sealed with minimal headspace, for each data point. These sample solutions were shielded from light whilst maintained at the test temperature.Sample solutions at pH 4, 7 and 9 were maintained at 50.0 ± 0.5 °C for a period of 120 hours.
RESULTS
The estimated half-life at 25 °C of the test item was shown to be greater than 1 year at pH 4, 7 and 9.
Reference
VALIDATION
- The linearity of the detector response with respect to concentration was assessed over the nominal concentration range of 120 to 1.20 x 10E03 mg/L.
- The results were satisfactory with a correlation coefficient (r) of 0.999 being obtained.
Description of key information
The estimated half-life at 25 °C of the research material was shown to be greater than 1 year at pH 4, 7 and 9 (OECD 111 and EU Method C.7).
Key value for chemical safety assessment
Additional information
GUIDELINE
Assessment of hydrolytic stability was carried out using Method C.7 Abiotic Degradation, Hydrolysis as a Function of pH of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 111 of the OECD Guidelines for Testing of Chemicals, 13 April 2004.
METHODS
The test system consisted of buffer solutions at pH 4, 7 and 9. The buffer solutions were passed through a 0.2 μm membrane filter to sterilise and subjected to ultrasonication and degassing with nitrogen to minimise dissolved oxygen. Duplicate sample solutions were taken initially and from the water bath at various time points. The pH of each solution recorded. The concentration of test item in the sample solutions was determined by high performance liquid chromatography (HPLC).
Stock solutions of test item were prepared at a nominal concentration of 1.0 x10E03 mg/L in the three buffer solutions. At this concentration the pH 4 stock precipitated. It was therefore passed through a filter paper and the filtrate diluted by a factor of 2 with the pH 4 buffer solution. This produced a stock solution than was half saturation as required by the test guidelines.
The stock solutions were split into individual glass vessels, sealed with minimal headspace, for each data point. These sample solutions were shielded from light whilst maintained at the test temperature.Sample solutions at pH 4, 7 and 9 were maintained at 50.0 ± 0.5 °C for a period of 120 hours.
RESULTS
The estimated half-life at 25 °C of the test item was shown to be greater than 1 year at pH 4, 7 and 9.
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