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Diss Factsheets
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EC number: 201-615-9 | CAS number: 85-56-3
- 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
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From May 12, 2017 to May 17, 2017
- 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)
- Analytical monitoring:
- yes
- Details on sampling:
- No sample preparation was performed
- Buffers:
- Buffer solutions:
pH 4.0: 1 mL 0.2 M Sodium hydroxide and 125 mL 0.2 M Potassium hydrogen phthalate was diluted to 500 mL with ultrapure water
pH 7.0: 73.9 mL 0.2M Sodium hydroxide and 125 mL 0.2 M Potassium dihydrogen phosphate was diluted to 500 mL with ultrapure water
pH 9.0: 53.5 mL 0.2M Sodium hydroxide and 125 mL 0.2M Boric acid and Potassium chloride was diluted to 500 mL with ultrapure water
These sterile buffer solutions were prepared using reagent grade chemicals and ultrapure, sterile water. - Details on test conditions:
- - Test temperature: 49.6-50.3°C
- Hydrolysis was examined at three different pH values: 4, 7 and 9 in the dark.
- The pH of each buffer solution was checked with a calibrated pH meter.
- The hydrolysis reaction was carried out using a dark thermostat to avoid photolytic effects.
- Nitrogen was bubbled into the water before the preparation of the solutions inorder to exclude oxygen. - Duration:
- 5 d
- pH:
- 4
- Initial conc. measured:
- ca. 0.187 - ca. 0.188 mg/L
- Duration:
- 5 d
- pH:
- 7
- Initial conc. measured:
- ca. 0.174 - ca. 0.176 mg/L
- Duration:
- 5 d
- pH:
- 9
- Initial conc. measured:
- ca. 0.183 - ca. 0.183 mg/L
- Number of replicates:
- Triplicate
- Positive controls:
- no
- Negative controls:
- no
- Preliminary study:
- In the course of the preliminary test the observed hydrolysis of test substance was less than 10% after 5 d at a temperature of 50±0.5°C at pH 4, 7 and 9. Therefore the test substance is considered to be hydrolytically stable under these circumstances and no additional testing is required.
- Test performance:
- 100 mL sterile solutions were prepared (about 180 μg/mL of test item concentration in each buffer). The solutions were ultrasonicated and filtered on 0.22 μm filter. The pH of each buffer solution was checked with a calibrated pH meter. Solutions were transferred into screw cap tubes. Three from each test solution and one control tubes were prepared. The tubes were thermostated at 49.6-50.3°C. The reaction solutions were analysed at the start of the test and after five days with three replicate samples each. The Day 5 samples were cooled to room temperature. Samples for the start and for the end were diluted with diluent (acetonitrile : ultrapure water = 1: 1) 100 fold, then they were analysed with the above presented HPLC-UV method.
- Transformation products:
- no
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- Remarks on result:
- hydrolytically stable based on preliminary test
- Details on results:
- Refer to the preliminary test results above.
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the study conditions, the test substance solution was considered to be hydrolytically stable.
- Executive summary:
A study was conducted to determine the hydrolytic stability of the test substance according to OECD Guideline 111 and EU Method C.7, in compliance with GLP. 100 mL sterile solutions were prepared (about 180 μg/mL of test substance) in each buffer pH 4.0, 7.0, 9.0, and were transferred into screw cap tubes. Three from each test solution and one control tubes were prepared. The tubes were thermostated at 49.6-50.3°C. The reaction solutions were analysed at the start of the test and after 5 d with three replicate samples each. The Day 5 samples were cooled to room temperature. Samples for the start and for the end were diluted with diluent (acetonitrile: ultrapure water = 1:1) 100 fold, then they were analysed using HPLC-UV. In the course of the preliminary test, the observed hydrolysis of test substance was less than 10% after 5 d at a temperature of 50±0.5°C and pH 4, 7 and 9. Under the study conditions, the test substance was considered to be hydrolytically stable (Bodnár, 2017).
Reference
The hydrolysis test was performed at 49.6-50.3°C, at pH 4, 7 and 9. Measured concentrations and pH values are summarised in below table.
pH | Sampling time, day |
Concentration of test substance, μg/mL |
Mean of the measured pH |
||
Results of |
Mean with the 95% confidence intervals (μg/mL) |
End/Start, % | |||
4 | 0 (start) | Control buffer | - | 4.01 | |
188 | 187 ± 1.13 | - | 4.01 | ||
187 | |||||
187 | |||||
5 | Control buffer | - | 4.00 | ||
187 | 186 ± 2.19 | 100 | 4.01 | ||
187 | |||||
185 | |||||
7 | 0 (start) | Control buffer | - | 7.00 | |
174 | 175 ± 3.09 | - | 6.99 | ||
175 | |||||
176 | |||||
5 | Control buffer | - | 7.01 | ||
180 | 180 ± 0.63 | 103 | 7.02 | ||
180 | |||||
180 | |||||
9 | 0 (start) | Control buffer | - | 9.00 | |
180 | 180 ± 4.88 | - | 8.98 | ||
183 | |||||
179 | |||||
5 |
Control buffer | - | 9.00 | ||
183 |
183 ± 0.96 |
102 |
8.98 |
||
183 |
|||||
183 |
Description of key information
Key value for chemical safety assessment
Additional information
A study was conducted to determine the hydrolytic stability of the test substance according to OECD Guideline 111 and EU Method C.7, in compliance with GLP. 100 mL sterile solutions were prepared (about 180 μg/mL of test substance) in each buffer pH 4.0, 7.0, 9.0, and were transferred into screw cap tubes. Three from each test solution and one control tubes were prepared. The tubes were thermostated at 49.6-50.3°C. The reaction solutions were analysed at the start of the test and after 5 d with three replicate samples each. The Day 5 samples were cooled to room temperature. Samples for the start and for the end were diluted with diluent (acetonitrile: ultrapure water = 1:1) 100 fold, then they were analysed using HPLC-UV. In the course of the preliminary test, the observed hydrolysis of test substance was less than 10% after 5 d at a temperature of 50±0.5°C and pH 4, 7 and 9. Under the study conditions, the test substance was considered to be hydrolytically stable (Bodnár, 2017).
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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