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EC number: 219-708-8 | CAS number: 2503-73-3
- 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
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- Auto flammability
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- 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
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- Nanomaterial pour density
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- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
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- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Toxicological Summary
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- 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:
- 15.08.2016-24.08.2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- Buffers:
- The hydrolysis of test substance was examined at buffered solutions of selected pH value: 4, 7 and 9. The actual pH value at given temperature was measured using a calibrated pH meter. All prepared buffer solutions were sterilized in a pressure cooker for 50 min and purged by nitrogen. -Buffer pH 4.0-pH 4.04, (24.1°C)-Buffer pH 7.0-pH 6.94 (24.1°C)-Buffer pH 9.0-pH 8.92 (24.1°C)Preparation of mobile phases:A: Approximately 0.39 g of CH3COONH4 was dissolved in 1L of deionized H2O. B: 50 mL of deionized H2O and 950 mL of MeOH were mixed.
- Details on test conditions:
- TTEST SYSTEM- Type, material and volume of test flasks, other equipment used: volumetric flask wrapped with an aluminum foil and tightly closed with a stopper.- Sterilisation method: All glassware, reagent-grade water and buffer solutions were sterilized in an autoclave (121 °C, 50 min).TEST MEDIUM- Kind and purity of water: deonized waterCALIBRATION SOLUTIONSStock Solution (SS, 10 000 mg/L): ): Approximately 50 mg of Direct Blue 78 was weighed into a 50 mL volumetric flask, dissolved in and diluted to volume with deionized H2O.SAMPLE SOLUTIONS4.19 mL of (1000 mg/L) standard solution were pipetted into a 50mL volumetric flask and diluted with a buffered solution of certain pH (4, 7, or 9) – in duplicate. A nominal concentration of 80 mg/L Direct Blue 78 was prepared. Each buffered sample solution was bubbled with nitrogen for at least 5 min. The sample solutions in volumetric flasks were wrapped with an aluminum foil and tightly closed with a stopper. During the experimental part of hydrolysis, the volumetric flasks were placed in the thermostatic bath kept at a given temperature. At certain period of time, a portion of sample solution was transferred into a vial followed by a quick cooling to room temperature.
- Duration:
- 5.05 d
- pH:
- 3.95
- Temp.:
- 50 °C
- Duration:
- 5.05 d
- pH:
- 6.97
- Temp.:
- 50 °C
- Duration:
- 5.05 d
- pH:
- 8.95
- Temp.:
- 50 °C
- Number of replicates:
- 2
- Positive controls:
- no
- Negative controls:
- no
- Preliminary study:
- The preliminary test was performed at 50 °C over the period of 5 days. All glassware, reagent-grade water and buffer solutions were sterilized in a pressure cooker for 50 min. The actual pH value of each buffered solution is given in Table 2. There was no observation of degradation greater than 10 % in all buffered solutions over period of 5 days. Test substance was considered to be stable at all tested pH values (Table 3).
- Transformation products:
- no
- % Recovery:
- -1.3
- pH:
- 3.95
- Temp.:
- 50 °C
- Duration:
- 5.05 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- -4.7
- pH:
- 6.97
- Temp.:
- 50 °C
- Duration:
- 5.05 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- -4.8
- pH:
- 8.92
- Temp.:
- 50 °C
- Duration:
- 5.05 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 3.95
- Temp.:
- 50 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 6.97
- Temp.:
- 50 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 8.92
- Temp.:
- 50 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Remarks on result:
- hydrolytically stable based on preliminary test
- Validity criteria fulfilled:
- yes
- Conclusions:
- The preliminary test has shown that the test substance was not hydrolyzed by more than 10% in period of 5 days at pH 4, 7 and 9. Therefore the test substance was considered to be hydrolytically stable at above pHs. It can be assumed that the half-time at 25 °C would be > 1 year.
- Executive summary:
The procedure was performed according to: Method C.7 – Degradation – Abiotic Degradation: Hydrolysis as a Function of pH, Council regulation (EC) No 440/2008. Published in OJ No L 142/518 May 2008 and OECD Test Guidline No.111, Hydrolysis as a function of pH, Adopted April 13, 2004.
The preliminary test has shown that the test substance was not hydrolyzed by more than 10% in period of 5 days at pH 4, 7 and 9. Therefore the test substance was considered to be hydrolytically stable at above pHs. It can be assumed that the half-time at 25 °C would be > 1 year.
Reference
Table2:pH values of buffersolutions
pH at room temperature | pH at 50 °C |
4.04 | 3.95 |
6.94 | 6.97 |
8.92 | 8.95 |
Table3:Results of preliminary test
pH 3.95 at 50 °C | pH 6.97 at 50 °C | pH 8.95 at 50 °C | |||
Days | Hydrolysis (%) | Days | Hydrolysis (%) | Days | Hydrolysis (%) |
0.00 | 0.0 | 0.00 | 0.0 | 0.00 | 0.0 |
3.11 | -0.6 | 3.11 | -1.7 | 3.11 | -1.7 |
4.19 | -1.0 | 4.19 | -2.9 | 4.19 | -2.7 |
5.05 | -1.3 | 5.05 | -4.7 | 5.05 | -4.8 |
Description of key information
Test was performed according to the Method C.7 – Degradation – Abiotic Degradation: Hydrolysis as a Function of pH, Council regulation (EC) No 440/2008. Published in OJ No L 142/518 May 2008 and OECD Test Guidline No.111, Hydrolysis as a function of pH, Adopted April 13, 2004.
Only one study is available.
GLP study.
Klimish score 1.
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 1 yr
- at the temperature of:
- 25 °C
Additional information
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