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EC number: 482-110-2 | 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
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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
- Study period:
- July 28, 2003 – August 7, 2003
- 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)
- Version / remarks:
- 2002
- Deviations:
- yes
- Remarks:
- The test solutions were heated at 54°C for 8 days instead of the OECD recommended 50°C for 5 days in order to provide additional supportive data on the hydrolysis of the test substance.
- GLP compliance:
- yes
- Remarks:
- OECD GLP
- Radiolabelling:
- no
- Analytical monitoring:
- yes
- Buffers:
- The pH 4 buffer was prepared by mixing 41.0 mL of an acetate buffer (1.155 mL glacial acetic acid in 1.000 L of deionized water; 0.02 M) with 9.0 mL of a 1.64 g/L anhydrous sodium acetate solution or 2.72 g/L trihydrate solution (0.02 M).
The pH 7 buffer was prepared by titrating a 10.93 g/L of MOPS: 3-N-morpholino propanesulfonic acid solution to pH 7.0 with approximately 20 mL of approximately 1.00 N aqueous NaOH.
The pH 9 buffer was prepared by titrating a 1.36 g/L ethanolamine solution (0.02 M) to pH 9.0 with approximately 32 mL of 1.0 M HCl and made up to 1000 mL with deionized water.
Aliquots of all three buffers were further diluted with deionized water to prepare buffers at a concentration of 5 mM. The pH of each of the three diluted buffers was measured, but not adjusted. - Details on test conditions:
- A solution of the test substance was prepared by rapidly weighing 365.14 mg of the test substance (to minimize absorption of moisture) and dissolving it in 10.00 mL of deionized water (36.51 mg/mL). This solution was used immediately. Stock solutions of the test substance were prepared by adding 100 microliters of the test substance solution to 20.0 mL of each buffer solution and deionized water in 50-mL polypropylene centrifuge tubes and vortexing. To prepare the test solutions, these stock solutions were aliquotted (1.0 mL) to 1.8-mL screw-cap (Teflon) vials and placed in envelopes. Day 0 test solutions (vials in envelope E0) were immediately stored horizontally (to prevent cracking) at -20°C. The pHs of the remaining stock solutions were measured.
The heated solutions, in envelopes E1, E2, E3, E4, and E7, were placed in the 54°C incubator such that the vials were horizontal to facilitate mixing. The remaining stock solutions in 50-mL polypropylene centrifuge tubes were also placed in the incubator. The time was noted and the rotating mixer was turned on (~1 rps). The calibrated temperature logger, set to log temperatures every 8 minutes, was turned on.
On day 1, after 24 h, E1 was removed from the incubator and placed horizontally at approximately -20°C. Removal time was recorded. This was repeated on day 2 through day 4 and on day 8; each day the appropriate envelope was removed from the incubator and placed at approximately -20°C. The average incubator temperature was 53.5 ± 0.7°C over the first 6 days of the 8 day heating period (due to shortage of temperature logger memory space). The incubator was not observed to malfunction on the 8th (last) day of heating. On day 8, the stock solutions in 50-mL polypropylene centrifuge tubes were removed from the incubator, cooled to approximately 22°C, and their pHs were measured. - Duration:
- 8 d
- pH:
- 4
- Temp.:
- 54 °C
- Duration:
- 8 d
- pH:
- 7
- Temp.:
- 54 °C
- Duration:
- 8 d
- pH:
- 9
- Temp.:
- 54 °C
- Number of replicates:
- 12 per pH
- Preliminary study:
- The pHs of the (nominal) pH 4, pH 7, and pH 9 buffer Stock Solutions at the end of the test (after heating for 8 d) were different from their nominal values by not more than 0.3 pH units.
The test material was observed in the Heated Solutions as a HPLC peak at 5.3 min. The corresponding observed test material concentrations in these solutions were between 95 % and 106 % of their initial concentrations, indicating that the extents of test material degradation after heating in buffers for 8 d at 54 °C were less than the OECD threshold of 10 % (OECD, 2002). It was expected that the extents of degradation after heating at the OECD-recommended conditions of 50 °C for 5 d (OECD, 2002) would also be less than 10 %, based on the general principle that reaction rate (of a thermal reaction) is directly proportional to temperature, and the extent of a reaction (% conversion) is directly related to time (McQuarrie, 1984).
Based on these results, the test material was found to be hydrolytically stable at pH 4, pH 7, and pH 9, as defined by the OECD, i.e., less than 10 % degradation of the test material was observed after 8 d at 54 °C, indicating that its half-life was greater than 1 year at 25 °C. - Transformation products:
- not measured
- Key result
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Key result
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Key result
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Details on results:
- No further testing was required as less than 10 % of the reaction was observed after 5 days in accordance with the OECD 111 Guidelines.
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the conditions of this study, the test material was found to be hydrolytically stable at pH 4, pH 7, and pH 9.
- Executive summary:
The hydrolytic stability of the test material was investigated in accordance with the standardised guidelines OECD 111, under GLP conditions.
The OECD hydrolysis screening test was conducted in which test material solutions in buffers (pH 4, 7, and 9) were heated at 54 ± 1 °C for up to 8 days. The HPLC results indicated that the concentrations of test material at the end of the heating period were between 96 % and 106 % of their initial concentrations, indicating
that the extents of test material degradation during heating were less than the OECD threshold of 10 % (half-life > 1 year at 25 °C).Under the conditions of this study, the test material was found to be hydrolytically stable at pH 4, pH 7, and pH 9.
Reference
Observed Test Substance Concentrations in Test Solutions
Labela |
HPLC Area |
Test Sbustance Conc. (micrograms/mL) |
Averageb |
Deviation |
% RD |
% of Initial Test Substance Conc.c |
Heating Time (days) |
9-0a |
1830 |
183.0 |
182.3 |
0.7 |
0.4 |
-- |
0.0 |
9-0b |
1817 |
181.6 |
-- |
0.0 |
|||
9-1a |
1828 |
182.8 |
181.4 |
1.4 |
0.8 |
100 |
1.0 |
9-1b |
1801 |
180.0 |
99 |
1.0 |
|||
9-2a |
1801 |
180.0 |
NA |
99 |
2.0 |
||
9-2bd |
1063 |
103.2 |
57d |
2.0 |
|||
9-3a |
1813 |
181.3 |
180.3 |
1.0 |
0.5 |
99 |
3.0 |
9-3b |
1794 |
179.3 |
98 |
3.0 |
|||
9-4a |
1890 |
189.3 |
186.1 |
3.2 |
1.7 |
104 |
4.0 |
9-4b |
1829 |
182.9 |
100 |
4.0 |
|||
9-7a |
1836 |
183.6 |
183.8 |
0.1 |
0.1 |
101 |
7.7 |
9-7b |
1838 |
183.9 |
101 |
7.7 |
|||
4-0a |
1876 |
187.8 |
189.0 |
1.2 |
0.6 |
-- |
0.0 |
4-0b |
1899 |
190.2 |
-- |
0.0 |
|||
4-1a |
1853 |
185.5 |
183.6 |
1.8 |
1.0 |
98 |
1.0 |
4-1b |
1818 |
181.8 |
96 |
1.0 |
|||
4-2a |
1859 |
186.1 |
182.6 |
3.5 |
1.9 |
98 |
2.0 |
4-2b |
1792 |
179.1 |
95 |
2.0 |
|||
4-3a |
1813 |
181.3 |
186.1 |
4.8 |
2.6 |
96 |
3.0 |
4-3b |
1906 |
190.9 |
101 |
3.0 |
|||
4-4a |
1823 |
182.4 |
182.6 |
0.2 |
0.1 |
96 |
4.0 |
4-4b |
1828 |
182.8 |
97 |
4.0 |
|||
4-7a |
1831 |
183.2 |
191.4 |
8.2 |
4.3 |
97 |
7.7 |
4-7b |
1990 |
199.7 |
106 |
7.7 |
|||
7-0a |
1851 |
185.2 |
185.5 |
0.3 |
0.1 |
-- |
0.0 |
7-0b |
1856 |
185.8 |
-- |
0.0 |
|||
7-1a |
1883 |
188.5 |
185.4 |
3.2 |
1.7 |
102 |
1.0 |
7-1b |
1822 |
182.2 |
98 |
1.0 |
|||
7-2a |
1836 |
183.6 |
183.0 |
0.6 |
0.3 |
99 |
2.0 |
7-2b |
1824 |
182.5 |
98 |
2.0 |
|||
7-3a |
1827 |
182.7 |
183.5 |
0.8 |
0.4 |
98 |
3.0 |
7-3b |
1841 |
184.2 |
99 |
3.0 |
|||
7-4a |
1855 |
185.7 |
185.2 |
0.5 |
0.2 |
100 |
4.0 |
7-4b |
1847 |
184.8 |
100 |
4.0 |
|||
7-7a |
1826 |
182.6 |
183.9 |
1.3 |
0.7 |
98 |
7.7 |
7-7b |
1851 |
185.2 |
100 |
7.7 |
|||
Average: 1.0 % |
|||||||
a 4-, 7-, and 9- indicate pH 4, pH 7, and pH 9, respectively; -0 solutions were frozen, other solutions were incubated at 54°C and then moved to frozen storage at the specified sampling interval prior to analysis. b averages of a and b duplicates c initial concentration is the average of the corresponding -0 duplicate samples d the result for this sample was assumed to be an outlier, which appeared to be due to an injection error based on chromatogram features |
Description of key information
Under the conditions of this study, the test material was found to be hydrolytically stable at pH 4, pH 7, and pH 9.
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 1 yr
- at the temperature of:
- 25 °C
Additional information
The hydrolytic stability of the test material was investigated in accordance with the standardised guidelines OECD 111, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
The OECD hydrolysis screening test was conducted in which test material solutions in buffers (pH 4, 7, and 9) were heated at 54 ± 1 °C for up to 8 days. The HPLC results indicated that the concentrations of test material at the end of the heating period were between 96 % and 106 % of their initial concentrations, indicating
that the extents of test material degradation during heating were less than the OECD threshold of 10 % (half-life > 1 year at 25 °C).
Under the conditions of this study, the test material was found to be hydrolytically stable at pH 4, pH 7, and pH 9.
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.
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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