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EC number: 436-010-0 | CAS number: 422278-61-3 PRIMID V40-32
- 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:
- From June 13th to Aufust 2nd, 2001
- 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)
- Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- During the preliminary test at 50 °C, aliquots of each test solution were analysed at the beginning and after 2.4 and 120 hours.
Further sampling were performed at 65 and 75 °C for the buffered test solutions at pH 7 and 9. - Buffers:
- Buffer pH4, Biphtalate
Buffer pH7, Phosphate
Buffer pH9, Borate/Potassium chloride/NaOH - Estimation method (if used):
- The reaction rate constant k was calculated for pH 7 and 9 by regression analysis using Arrhenius equation.
- Details on test conditions:
- EQUIPMENT
The buffer solutions were sterilized for 25 minutes in an autoclave prior to first use. Nitrogen was passed through the buffer solutions for 5 minutes except when freshly sterilized.
All glassware, which must be inert at pH range applied, were rinsed with sterile buffer. The hydrolysis was carried out in flasks which were stoppered or sealed with an inert material (e.g. PTFE).
The water bath used was the thermostatically controlled GFL 1086.
PERFORMANCE OF THE TEST
The test item was dissolved in the buffer solutions and incubated at specific temperatures with the water bath kept constant at ± 0.1 °C, usually.
The concentration of test item was determined as a function of time at each pH.
The preliminary hydrolysis tests were performed at 50 °C ± 0.1 °C at pH 4, 7 and 9.
Further hydrolysis tests were performed at 65 °C and 75 °C in the buffered test solution at pH 7 and 9, due to instability of test item found in preliminary tests.
At pH 4 test item was stable at 50 °C, therefore no further testing was perfomed.
Test solutions were prepared by dissolving 11 ± 0.5 mg of test item in 100 mL buffer solution, different for each pH. The solutions were treated in an ultrasonic bath for 3 minutes and then filtrated (0.45 μm). Two aliquots of test solutions of approximately 50 mL each were transferred into 50 mL Erlenmeyer flasks in order to perform a duplicate test. - Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- >= 99 - <= 100 mg/L
- Remarks:
- Preliminary study
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- >= 107 - <= 108 mg/L
- Remarks:
- Preliminary study
- Duration:
- 120 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 106 mg/L
- Remarks:
- Preliminary study
- Duration:
- 1 037 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- >= 107 - <= 108 mg/L
- Remarks:
- Main study
- Duration:
- 628 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 106 mg/L
- Remarks:
- Main study
- Duration:
- 260.8 h
- pH:
- 7
- Temp.:
- 65 °C
- Initial conc. measured:
- >= 105.5 - <= 106.3 mg/L
- Duration:
- 106.5 h
- pH:
- 7
- Temp.:
- 75 °C
- Initial conc. measured:
- >= 99.5 - <= 100.5 mg/L
- Duration:
- 209.7 h
- pH:
- 9
- Temp.:
- 65 °C
- Initial conc. measured:
- >= 109.7 - <= 110 mg/L
- Duration:
- 67.5 h
- pH:
- 9
- Temp.:
- 75 °C
- Initial conc. measured:
- >= 110.5 - <= 111.1 mg/L
- Number of replicates:
- 2 for each pH and temperature
- Positive controls:
- no
- Negative controls:
- no
- Preliminary study:
- At pH 4, substance was completely stable after 120 hours (2% degradation) at 50 °C. No further testing was performed at pH 4.
At pH 7 and 9 substance was unstable after 120 hours (degradation 12-16%) at 50 °C. Testing was prolonged to calculate half-life time at 50 °C. - Test performance:
- At pH 7 and 9 further studies were performed at 65 °C and 75 °C in order to calculate rate constants and half-life time at those temperatures and then to determine parameters at 25 °C.
- Transformation products:
- not measured
- Details on hydrolysis and appearance of transformation product(s):
- Not applicable
- % Recovery:
- 98
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 120 h
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- >= 86 - <= 88
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 120 h
- Remarks on result:
- other: Unstable after preliminary study
- % Recovery:
- >= 84 - <= 85
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 120 h
- Remarks on result:
- other: Unstable after preliminary study
- % Recovery:
- >= 36 - <= 39
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 1 037 h
- Remarks on result:
- other: Main study result
- % Recovery:
- >= 36 - <= 37
- pH:
- 7
- Temp.:
- 65 °C
- Duration:
- 260.8 h
- % Recovery:
- >= 32 - <= 33
- pH:
- 7
- Temp.:
- 75 °C
- Duration:
- 106.5 h
- % Recovery:
- >= 38 - <= 39
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 628 h
- Remarks on result:
- other: main study result
- % Recovery:
- 30
- pH:
- 9
- Temp.:
- 65 °C
- Duration:
- 209.7 h
- % Recovery:
- 38
- pH:
- 9
- Temp.:
- 75 °C
- Duration:
- 67.5 h
- Key result
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 365 d
- Type:
- other: estimated from preliminary study results
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 7
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- >= 0.001 - <= 0.001 h-1
- DT50:
- 31 d
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 9
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- >= 0.002 - <= 0.002 h-1
- DT50:
- 37 d
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 7
- Temp.:
- 65 °C
- Hydrolysis rate constant:
- >= 0.004 - <= 0.004 h-1
- DT50:
- 7.5 d
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 7
- Temp.:
- 75 °C
- Hydrolysis rate constant:
- >= 0.01 - <= 0.01 h-1
- DT50:
- 2.8 d
- Type:
- (pseudo-)first order (= half-life)
- Key result
- pH:
- 7
- Temp.:
- 25 °C
- Hydrolysis rate constant:
- 0 h-1
- DT50:
- 514 d
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 9
- Temp.:
- 65 °C
- Hydrolysis rate constant:
- >= 0.006 - <= 0.006 h-1
- DT50:
- 4.9 d
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 9
- Temp.:
- 75 °C
- Hydrolysis rate constant:
- >= 0.014 - <= 0.015 h-1
- DT50:
- 2 d
- Type:
- (pseudo-)first order (= half-life)
- Key result
- pH:
- 9
- Temp.:
- 25 °C
- Hydrolysis rate constant:
- 0 h-1
- DT50:
- 253 d
- Type:
- (pseudo-)first order (= half-life)
- Results with reference substance:
- Not applicable
- Validity criteria fulfilled:
- yes
- Conclusions:
- The substance does not rapidly hydrolyse at 25 °C at all pH values evaluated (4,7 and 9).
The substance was stable at pH 4. Its half-life time at 25 °C is longer than one year.
Half-life time of the substance at pH 7 (25 °C) was found to be 514 days (12336 hours).
Half-life time of the substance at pH 9 (25 °C) was found to be 253 days (6072 hours). - Executive summary:
The hydrolysis of the substance was tested in a study according to OECD TG 111.
The preliminary experiment was performed at 50 °C and pH 4.0, 7.0 and 9.0. Test item was found to be stable at pH 4.0, therefore no further testing was performed at this pH value.
Substance was not stable at pH 7 and 9, thus further testing was perfomed at 65 and 75 °C in order to calculate the rate constant (k25) and the half-life time of hydrolysis at 25 °C (using Arrhenius equation).
The substance was stable at pH 4. Its half-life time at 25 °C is longer than one year.
Half-life time of the substance at pH 7 (25 °C) was found to be 514 days (12336 hours).
Half-life time of the substance at pH 9 (25 °C) was found to be 253 days (6072 hours).
Reference
Description of key information
In a study according to OECD TG 111, half-life time of the substance was evaluated at different pHs:
The substance was stable at pH 4. Its half-life time at 25 °C is longer than one year.
Half-life time of the substance at pH 7 (25 °C) was found to be 514 days (12336 hours).
Half-life time of the substance at pH 9 (25 °C) was found to be 253 days (6072 hours)
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 513 d
- at the temperature of:
- 25 °C
Additional information
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