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EC number: 258-605-2 | CAS number: 53523-90-3
- 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
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Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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)
- Version / remarks:
- Council Regulation EC No 440/2008
- Deviations:
- no
- Principles of method if other than guideline:
- In case compounds react chemically with water a hydrolysis reaction takes place. It’s the target of a hydrolysis study to determine whether or not and how fast a compound reacts with water. The reaction kinetics and the influence of temperature and pH-value on the stability of the test item will be determined.
In the environment chemicals usually occur in dilute solution which means that water is present in large excess. Therefore the concentration of water remains essentially constant during hydrolysis. Hence the kinetics of hydrolysis is generally pseudo-first order at a fixed pH and temperature. The hydrolysis reaction may be influenced by acidic or basic species H3O+(H+) and OH- in which case it is referred to as specific acid or specific base catalysis. The concentration of the test substance in the test water is determined as a function of time. The logarithms of the concentrations are plotted against time and the slope of the resulting straight line (assuming first-order or pseudo-first order behaviour) gives the rate constant from the formula.
kobs = - slope ∙ 2.303 (if log10 is used).
When the rate constants are known for two or more temperatures, the rate constants at other temperatures can be calculated using the Arrhenius equation.
The guideline describes a tiered approach starting with a preliminary test at 50 °C at pH 4, pH 7 and pH 9. The next steps (choice of pH-value, temperature and length of test) depend on the results of the preliminary test.
According to OECD Guideline 111 this guideline is only valid for
• Pure compounds (content greater than approx. 95 %)
• Compounds with a suitable water solubility
• Compounds for which analytical methods are available for the test item and hydrolysis products in aqueous solutions. - GLP compliance:
- yes
- Specific details on test material used for the study:
- Storage conditions: room temperature
Date of receipt: 2016-06-20
Expiry date: 2018-06-17 - Radiolabelling:
- no
- Analytical monitoring:
- yes
- Remarks:
- HPLC
- Details on sampling:
- Storage conditions: room temperature
- Buffers:
- Preparation and procedure of the tests
All buffer solutions were filled in glass bottles and purged with N2 for five minutes.
Afterwards the buffer solutions were sterilized at 120 °C for 20 minutes. Before the beginning of the tests the solutions are tempered and the temperature was checked.
All glassware was purged with N2 before and after filling in the test item and the buffer solutions. The test solutions were overlain with N2.
Reagents and Materials
Buffer pH 4 Citric acid/NaOH/NaCl; Fluka, order no.: 33643
Buffer pH 7 KH2PO4/Na2HPO4, Fluka, order no.: 33646
Buffer pH 9 Na2B4O7/HCl, Fluka, order no.: 33648 - Estimation method (if used):
- The concentration of the test substance in the test water is determined as a function of time. The logarithms of the concentrations are plotted against time and the slope of the resulting straight line (assuming first-order or pseudo-first order behaviour) gives the rate constant from the formula.
kobs = - slope ∙ 2.303 (if log10 is used).
When the rate constants are known for two or more temperatures, the rate constants at other temperatures can be calculated using the Arrhenius equation. - Details on test conditions:
- Sterility test
To prove the sterility of the glass instruments and the test design, sterility tests of each buffer solution were performed at the end of the incubation.
Result: With the bacteria count of all buffer solutions the sterility of the tests was proofed. No microbes (colonies) were found.
Solubility and test concentration
According to OECD TG 111 the concentration of the test item should not exceed 0.01 M or half of the saturation concentration of the water solubility.
The water solubility of the test item was determined as 240 g/L.
Consequently, the test item was applied as aqueous buffer solution with a concentration of approx. 200 mg/L which fulfills the requirements of OECD 111.
Clear solutions were obtained.
HYDROLYSIS AT PH 4
Hydrolysis at 50 °C
Preparation of the test solution
47.1 mg of the test item were dissolved in 200 mL buffer pH 4 resulting in a test item concentration of 203.2 mg/L (0.00028 mol/L).
Aliquots of the test solution were directly filled into brown glass sample vials to obtain individual samples for each test point. Preparation was carried out under nitrogen as flushing gas to avoid oxygen.
The vials were closed and incubated at 50 °C in a heat regulator with electronic temperature control to the exclusion of light to avoid any photolytic effects. The temperature was checked during the experiment using a digital precision thermometer. No deviations above ± 0.5 °C from the target value were obtained.
At each test point the hydrolysis solution was directly analyzed by HPLC.
The pH of the blank buffer solution was checked at the beginning of the test. Additionally the pH of the hydrolysis solution was measured at each test point.
The suitability of the HPLC system during the hydrolysis study was verified on every day of application. The calibration was verified daily at the level of 198.5 mg/L by using a control calibration solution.
HYDROLYSIS AT PH 7
Hydrolysis at 50 °C
Preparation of the test solution
46.6 mg of the test item was dissolved in 200 mL buffer pH 7 resulting in a test item concentration of 201.1 mg/L (0.00028 mol/L).
Aliquots of the test solution were directly filled into brown glass sample vials to obtain individual samples for each test point. Preparation was carried out under nitrogen as flushing gas to avoid oxygen.
The vials were closed and incubated at 50 °C in a heat regulator with electronic temperature control to the exclusion of light to avoid any photolytic effects. The temperature was checked during the experiment using a digital precision thermometer. No deviations above ± 0.5 °C from the target value were obtained.
At each test point the hydrolysis solution was directly analyzed by HPLC.
The pH of the blank buffer solution was checked at the beginning of the test. Additionally the pH of the hydrolysis solution was measured at each test point.
The suitability of the HPLC system during the hydrolysis study was verified on every day of application. The calibration was verified daily at the level of 198.5 mg/L by using a control calibration solution.
HYDROLYSIS AT PH 9
Hydrolysis at 50 °C
Preparation of the test solution
47.2 mg of the test item was dissolved in 200 mL buffer pH 9 resulting in a test item concentration of 203.7 mg/L (0.00028 mol/L).
Aliquots of the test solution were directly filled into brown glass sample vials to obtain individual samples for each test point. Preparation was carried out under nitrogen as flushing gas to avoid oxygen.
The vials were closed and incubated at 50 °C in a heat regulator with electronic temperature control to the exclusion of light to avoid any photolytic effects. The temperature was checked during the experiment using a digital precision thermometer. No deviations above ± 0.5 °C from the target value were obtained.
At each test point the hydrolysis solution was directly analyzed by HPLC.
The pH of the blank buffer solution was checked at the beginning of the test. Additionally the pH of the hydrolysis solution was measured at each test point.
The suitability of the HPLC system during the hydrolysis study was verified on every day of application. The calibration was verified daily at the level of 198.5 mg/L by using a control calibration solution. - Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 203.2 mg/L
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 201.1 mg/L
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 203.7 mg/L
- Statistical methods:
- Repeatability
A relative standard deviation of approx. 1.1 % indicates a satisfying repeatability and precision of the method applied to quantify the test item concentrations over the test duration of 5 days. The requirements of OECD 111 are met.
Sensitivity
Regarding the chromatogram of the lowest concentration, taken from calibration measurement of repeatability tests, the analytical method is sufficiently sensitive to quantify test item concentrations down to 10 % or less of the initial concentration used in the hydrolysis experiment. - Transformation products:
- not measured
- % Recovery:
- 99.4
- pH:
- 3.9
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- other: Overall degradation of test item after 5 days less than 10%, therefore stable at 50 °C at pH 4 and no half-life time and hydrolysis rate were calculated
- % Recovery:
- 100.6
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- other: Overall degradation of test item after 5 days less than 10%, therefore stable at 50 °C at pH 7 and no half-life time and hydrolysis rate were calculated
- % Recovery:
- 101.27
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- other: Overall degradation of test item after 5 days less than 10%, therefore stable at 50 °C at pH 9 and no half-life time and hydrolysis rate were calculated
- Remarks on result:
- not determinable
- Remarks:
- No abiotic degradation of the test item was observed. Bayscript Gelbkomponente is found to be stable at 50 °C at all three pH-values. Therefore it can be assumed that the test item is also stable at 25 °C and no half-life times and hydrolysis rates were calculated.
- Results with reference substance:
- No reference substance used
- Validity criteria fulfilled:
- yes
- Conclusions:
- Bayscript Gelbkomponente is found to be stable at 50 °C at all three pH-values. Therefore it can be assumed that the test item is also stable at 25 °C and no half-life times and hydrolysis rates were calculated. No abiotic degradation of the test item was observed. The tests were performed according to OECD Guidelines for Testing of Chemicals, Section 1.
- Executive summary:
The tests were performed according to OECD Guidelines for Testing of Chemicals, Section 1 – Physical-Chemical Properties, OECD TG 111, Council Regulation (EC) No 440/2008, Guideline Part C – Methods for the Determination of Ecotoxicity, C.7. “Abiotic Degradation: Hydrolysis as a Function of pH”.
The hydrolysis behaviour of the test item was investigated at 50 °C at pH values of 4, 7 and 9 over a period of five days according to OECD TG 111. The stability was monitored by HPLC analysis using UV-detection.
The overall degradation of the test item at 50 °C at pH 4, 7 and 9 after 5 days was less than 10 %. Therefore the test item is considered to be stable at 50 °C at pH 4, 7 and 9.
No abiotic degradation of the test item was observed.
Bayscript Gelbkomponente is found to be stable at 50 °C at all three pH-values. Therefore it can be assumed that the test item is also stable at 25 °C and no half-life times and hydrolysis rates were calculated.
Reference
Description of key information
The tests were performed according to OECD Guidelines for Testing of Chemicals, Section 1 – Physical-Chemical Properties, OECD TG 111, Council Regulation (EC) No 440/2008, Guideline Part C – Methods for the Determination of Ecotoxicity, C.7. “Abiotic Degradation: Hydrolysis as a Function of pH”.
The hydrolysis behaviour of the test item was investigated at 50 °C at pH values of 4, 7 and 9 over a period of five days according to OECD TG 111. The stability was monitored by HPLC analysis using UV-detection.
The overall degradation of the test item at 50 °C at pH 4, 7 and 9 after 5 days was less than 10 %. Therefore the test item is considered to be stable at 50 °C at pH 4, 7 and 9.
No abiotic degradation of the test item was observed.
Bayscript Gelbkomponente is found to be stable at 50 °C at all three pH-values. Therefore it can be assumed that the test item is also stable at 25 °C and no half-life times and hydrolysis rates were calculated.
Key value for chemical safety assessment
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.
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