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EC number: 610-122-1 | CAS number: 433733-94-9
- 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:
- May - Oct 2019
- 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)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 835.2120 (Hydrolysis of Parent and Degradates as a Function of pH at 25°C)
- GLP compliance:
- yes
- Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- The concentrations of the test item were determined immediately after preparation (t=0) and at several sampling points after t=0.
Preliminary test
pH4, pH 7, pH 9:
Sampling time 0h, 2.4 hours, 5 days
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.
Main Test
The concentrations of the test item were determined at:
pH 7, pH 9 and
T20°C, T30°C, T50°C
For example:
pH7, T20°C:
Sampling time [hours]
0.00
140.33
261.93
287.88
330.87
404.18
430.70
475.58
503.65
576.83
675.73
813.80
Main Test pH 9, T20°C:
0.00
1.65
2.53
3.40
4.70
28.93
30.42
30.95
48.05
53.95
72.52
149.53 - Buffers:
- Acetate buffer pH 4, 0.1 M
Solution of 16.7% 0.1 M sodium acetate in water and 83.3% 0.1 M acetic acid in water. Buffer contained 0.0009% (w/v) sodium azide.
Phosphate buffer pH 7, 0.1 M
Solution of 0.1 M potassium di-hydrogenphosphate in water adjusted to pH 7 using 10N sodium hydroxide. Buffer contained 0.0009% (w/v) sodium azide.
Borate buffer pH 9, 0.1 M
Solution of 0.1 M boric acid in water and 0.1M potassium chloride in water adjusted to pH 9 using 10N sodium hydroxide. Buffer contained 0.0009% (w/v) sodium azide. - Estimation method (if used):
- Preliminary Test - Tier 1
The buffer solutions were 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. The test item was spiked to the
solutions at a target concentration of 2 mg/L using a spiking solution in methanol. 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 50.0°C 0.1°C.
The spiking volume was < 1% of the sample volume. Nominal concentrations were not
corrected for the spiking volume.
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. - Details on test conditions:
- Analysis was performed on subsamples of 750 μL. The samples were diluted in a 3:1 (v:v) ratio with acetonitrile and analyzed.
Blank buffer solutions containing a similar content of blank spiking solution 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 each sampling time. - Duration:
- 813.8 h
- pH:
- 7
- Temp.:
- 20 °C
- Initial conc. measured:
- >= 2.1 - <= 2.11 mg/L
- Duration:
- 720.68 h
- pH:
- 7
- Temp.:
- 30 °C
- Initial conc. measured:
- >= 2.06 - <= 2.07 mg/L
- Duration:
- 173.72 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- >= 2.1 - <= 2.11 mg/L
- Duration:
- 149.53 h
- pH:
- 9
- Temp.:
- 20 °C
- Initial conc. measured:
- >= 2.07 - <= 2.07 mg/L
- Duration:
- 47.88 h
- pH:
- 9
- Temp.:
- 30 °C
- Initial conc. measured:
- >= 2.05 - <= 2.06 mg/L
- Duration:
- 23.72 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- >= 2.08 - <= 2.08 mg/L
- Number of replicates:
- 2
- Positive controls:
- no
- Negative controls:
- no
- Statistical methods:
- For testing of pseudo-first order kinetics the mean logarithms of the relative concentrations
between 10% and 90% were plotted against time. At all temperatures linear relationships
were obtained.
The half-life times of the test item were determined according to the model for pseudo-first
order reactions. All logarithms of the relative concentrations were correlated with time using
linear regression analysis. - Preliminary study:
- At pH 7 and 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.
A degree of hydrolysis of < 10% was observed at pH 4 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.
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 specified
- Key result
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Type:
- (pseudo-)first order (= half-life)
- Key result
- pH:
- 7
- Temp.:
- 20 °C
- Hydrolysis rate constant:
- 0.001 h-1
- DT50:
- 47 d
- Type:
- (pseudo-)first order (= half-life)
- Key result
- pH:
- 7
- Temp.:
- 30 °C
- Hydrolysis rate constant:
- 0.002 h-1
- DT50:
- 16 d
- Type:
- (pseudo-)first order (= half-life)
- Key result
- pH:
- 7
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- 0.018 h-1
- DT50:
- 38 h
- Type:
- (pseudo-)first order (= half-life)
- Key result
- pH:
- 9
- Temp.:
- 20 °C
- Hydrolysis rate constant:
- 0.02 h-1
- DT50:
- 35 h
- Type:
- (pseudo-)first order (= half-life)
- Key result
- pH:
- 9
- Temp.:
- 30 °C
- Hydrolysis rate constant:
- 0.066 h-1
- DT50:
- 10 h
- Type:
- (pseudo-)first order (= half-life)
- Key result
- pH:
- 9
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- 0.613 h-1
- DT50:
- 1.1 h
- Type:
- (pseudo-)first order (= half-life)
- Validity criteria fulfilled:
- yes
- Conclusions:
- The half-life times of the test item were as follows:
pH 4 pH 7 pH 9
Temperature [°C] t½ Temperature [°C] t½ Temperature[°C] t½
20 47 days 20 35 hours
25 > 1 year 25 27 days 25 19 hours
30 16 days 30 10 hours
50 38 hours 50 1.1 hours
Reference
Description of key information
The half-life times of the test item were as follows:
pH 4 pH 7 pH 9
Temperature [°C] t½ Temperature [°C] t½ Temperature[°C] t½
20 47 days 20 35 hours
25 > 1 year 25 27 days 25 19 hours
30 16 days 30 10 hours
50 38 hours 50 1.1 hours
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 27 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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