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EC number: 212-216-4 | CAS number: 770-05-8
- 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
- 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
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch (Lot) Number: D151-1710037
Expiry date: 26 October 2019
Physical Description: White to off white powder (determined by Charles River Den Bosch)
Purity/Composition: 99.8% w/w
Storage Conditions: At room temperature protected from light - Radiolabelling:
- no
- Analytical monitoring:
- yes
- Buffers:
- Acetate buffer pH 4, 0.01 M Solution of 16.7% 0.01 M sodium acetate in water and 83.3% 0.01 M acetic acid in water. Buffer contained 0.0009% (w/v) sodium azide.
Phosphate buffer pH 7, 0.01 M Solution of 0.01 M potassium di-hydrogen-phosphate in water adjusted to pH 7 using 1N sodium hydroxide. Buffer contained 0.0009% (w/v) sodium azide.
Borate buffer pH 9, 0.01 M Solution of 0.01 M boric acid in water and 0.01 M potassium chloride in water adjusted to pH 9 using 1N sodium hydroxide. Buffer contained 0.0009% (w/v) sodium azide.
Acetate buffer pH 9, 0.1 M Solution of 0.1 M ammonium acetate in water adjusted to pH 9 using ammonia solution, 25%. Buffer contained 0.0009% (w/v) sodium azide.
- Details on test conditions:
- The rate of hydrolysis of the test item as a function of pH was determined at pH values normally found in the environment (pH 4-9).
Preliminary Test - Tier 1
Test item solutions were prepared in the buffer solutions at a target concentration of 300 mg/L. Each solution was filter-sterilised through a 0.2 µm FP 30/0.2 CA-S filter (Whatman, Dassel, Germany) and transferred into a sterile vessel. To exclude oxygen, nitrogen gas was purged through the solution for 5 minutes. For each sampling time, duplicate sterile vessels under vacuum were filled with 6 mL test solution and placed in the dark in a temperature controlled environment at 49.4°C 0.8°C.
The concentration of the test item in the test samples was determined immediately after preparation (t=0) and after 2.4 hours and 5 days. The samples taken at t=2.4 hours and t=5 days were cooled to room temperature using running tap water.
Analysis was performed on subsamples of 300 µL. The samples and the blank buffer solutions were diluted in a 3:7 (v:v) ratio with acetonitrile and analyzed.
The pH of each of the test solutions (except for the blanks) was determined at each sampling time.
Main Study - Tier 2
Test samples were prepared and treated similarly as during the preliminary test. The concentrations of the test item were determined immediately after preparation (t=0) and at several sampling points after t=0.
Blank buffer solutions were treated similarly as the test samples and analyzed at t=0.
The pH of each of the test solutions (except for the blanks) was determined at least at the beginning and at the end of the test. - Duration:
- 0 h
- pH:
- 4
- Temp.:
- 49.4 °C
- Initial conc. measured:
- ca. 280 mg/L
- Duration:
- 2.4 h
- pH:
- 4
- Temp.:
- 49.4 °C
- Initial conc. measured:
- ca. 280 mg/L
- Duration:
- 5 d
- pH:
- 4
- Temp.:
- 49.4 °C
- Initial conc. measured:
- ca. 292 mg/L
- Duration:
- 0 h
- pH:
- 7
- Temp.:
- 49.4 °C
- Initial conc. measured:
- ca. 341 mg/L
- Remarks:
- estimated concentration from calibration curve
- Duration:
- 2.4 h
- pH:
- 7
- Temp.:
- 49.4 °C
- Initial conc. measured:
- >= 343 - <= 346 mg/L
- Remarks:
- estimated concentration from calibration curve
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 49.4
- Initial conc. measured:
- >= 351 - <= 358 mg/L
- Remarks:
- estimated concentration from calibration curve
- Duration:
- 0 h
- pH:
- 9
- Temp.:
- 49.4
- Initial conc. measured:
- >= 289 - <= 292 mg/L
- Duration:
- 2.4 h
- pH:
- 9
- Temp.:
- 49.4 °C
- Initial conc. measured:
- >= 290 - <= 298 mg/L
- Duration:
- 5 d
- pH:
- 9
- Initial conc. measured:
- ca. 221 mg/L
- Number of replicates:
- duplicate
- Positive controls:
- no
- Negative controls:
- yes
- Statistical methods:
- Not Applicable
- Preliminary study:
- At pH 4 and pH 7, a degree of hydrolysis of < 10% was observed after 5 days. It demonstrated that the half-life time of the test item at 25°C is > 1 year. According to the guideline, no further tests were required.
At pH 9, a degree of hydrolysis of ≥ 10% was observed after 5 days. According to the guideline, the higher Tier test was required to determine the half-life time of the test item.
No test item was detected in the blank buffer solutions.
The mean recoveries of the of the test item containing buffer solutions at t=0 fell within the criterion range of 90-110%. It demonstrated that the analytical method was adequate to support the hydrolysis study on the test item. - Transformation products:
- not measured
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 9
- Temp.:
- 20 °C
- Hydrolysis rate constant:
- ca. 0 h-1
- DT50:
- ca. 305 d
- Type:
- (pseudo-)first order (= half-life)
- Key result
- pH:
- 9
- Temp.:
- 25 °C
- Hydrolysis rate constant:
- 0 h-1
- DT50:
- 149 d
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 9
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- ca. 0.005 h-1
- DT50:
- ca. 5.8 d
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 9
- Temp.:
- 60 °C
- Hydrolysis rate constant:
- 0.011 h-1
- DT50:
- ca. 2.6 d
- Type:
- (pseudo-)first order (= half-life)
- Validity criteria fulfilled:
- yes
Reference
Description of key information
The rate constant (kobs) and half-life time of the test item at each temperature (20, 50 and 60°C) was
obtained and the Arrhenius equation was used to determine the rate constant and half-life time at 25°C , which were calculated to be 1.93 x10E-4 hours and 149 days respectively.Key value for chemical safety assessment
- Half-life for hydrolysis:
- 149 d
- at the temperature of:
- 25 °C
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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