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EC number: 700-924-0 | 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
Hydrolysis
Administrative data
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-05-17 to 2013-05-22
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Version / remarks:
- / EC No. 440/2008 Method C.7
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- disodium 4-hydroxy-3-[(E)-2-[4-({4-[(E)-2-(1-hydroxy-4-sulfonaphthalen-2-yl)diazen-1-yl]-3-methoxyphenyl}(phenyl)methyl)-2-methoxyphenyl]diazen-1-yl]naphthalene-1-sulfonate
- EC Number:
- 700-924-0
- Molecular formula:
- C41H30N4Na2O10S2
- IUPAC Name:
- disodium 4-hydroxy-3-[(E)-2-[4-({4-[(E)-2-(1-hydroxy-4-sulfonaphthalen-2-yl)diazen-1-yl]-3-methoxyphenyl}(phenyl)methyl)-2-methoxyphenyl]diazen-1-yl]naphthalene-1-sulfonate
Constituent 1
- Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products:
Samples were taken at 0 h and after 120 h. All samples were diluted with acetonitrile: HPLC water (50:50) and analysed. All test item containing samples were analysed immediately (max. 30 minutes until start of analyses) via HPLC with UV (DAD) detection.
The bath temperature was checked automatically once in an hour and manually once per working day.
- Sample storage conditions before analysis: The samples were diluted with acetonitrile:HPLC water (50:50) at a total dilution factor of 4 and analysed. - Buffers:
- Sterile buffer solutions at pH 4, 7 and 9
Buffer solution pH 4 45 mL of 0.1 mol/L NaOH were mixed with 250 mL 0.1 mol/L KH2-Citrate and diluted to 500 mL with
double distilled water.
Buffer solution pH 7 148.15 mL of 0.1 mol/L NaOH were mixed with 250 mL 0.1 mol/L KH2PO4, diluted to 500 mL with double
distilled water.
Buffer solution pH 9 106.5 mL of 0.1 mol/L NaOH were mixed with 250 mL 0.1 mol/L H3BO3 in 0.1 mol/L KCL, diluted to 500 mL with double distilled water.
Buffers were prepared from chemicals with analytical grade or better quality. Buffers were purged with nitrogen for 5 min. Then the pH was checked to a precision of at least 0.1 at the test temperature, adjusted if necessary and sterilised by filtration through 0.2 µm.
Reason for the selection Buffer systems were selected according to the guidelines. The buffer systems were suitable for their pH value.
Details
Chemical Origin Batch number Purity [%]
NaOH VWR 12L110007 99.4
H3BO3 VWR 11E300005 100
KCl VWR 12D030022 99.7
KH2PO4 VWR 12E160023 100
KH2 Citrate FLUKA BCBH3957V ≥ 98
Double distilled water ROTH 422192602 1)
1) conductivity: < 2.0 μS/cm
- Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: HPLC vials, volume 4 mL
- Measures taken to avoid photolytic effects: Photolytic effects were avoided by using opaque water baths.
- Measures to exclude oxygen:
- Is there any indication of the test material adsorbing to the walls of the test apparatus? No
TEST MEDIUM
- Volume used/treatment: 50 mL
- Preparation of test medium: 50 mg of the test item was weighed and filled up to a volume of 50 mL with the respective sterile buffer. Afterwards the solutions were sterilised by filtration through 0.20 µm sterile membrane filters into the test containers. The test containers were sealed and transferred into the thermostat. The time between test item application and transfer to laboratory incubator/analysis did not exceed 30 minutes.
- Incubation: 120 hours
- Temperatures: 50 ± 0.5 °C
- Sterility: The solutions were sterilised by filtration through 0.20 µm sterile membrane filters into the test containers.
- Renewal of test solution: None
Duration of testopen allclose all
- Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 1.09 mg/L
- Duration:
- 599 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 1.01 mg/L
- Duration:
- 338 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 0.9 mg/L
- Number of replicates:
- Two replicates at each sampling interval
- Positive controls:
- no
- Negative controls:
- yes
- Remarks:
- buffer solutions (pH 4, 7 and 9)
Results and discussion
- Test performance:
- CHRONOLOGICAL
TEST DESCRIPTION
- Method validation
- Preparation of the (sterile) test solutions (experimental starting)
- Thermostatisation of the test solutions
- Analysis of samples
- Calculations
- Transformation products:
- no
- Details on hydrolysis and appearance of transformation product(s):
The test item was found to be stable in the preliminary test at pH 4, 7 and 9 at 50 °C (Table 1). Reaction rate constants and half-lives could not be calculated due to the fact that the test item undergoes no significant hydrolysis. According to the guideline a half life of > 1 year under environmental conditions can be assumed.
- Details on results:
- TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes
pH-Value of the Test System (50 °C)
measured at test temperature on day of preparation (before sterilisation)
Intended pH-value Measured pH-value at 50 °C
4.0 ± 0.1 4.02
7.0 ± 0.1 7.00
9.0 ± 0.1 8.96
The temperature was in good agreement with the nominal range throughout the test. The mean temperature was 49.9 °C with a minimum of 49.6 °C and a maximum of 50.0 °C during the study.
Any other information on results incl. tables
pH-Value of the Test System (50 °C)
measured at test temperature on day of preparation (before sterilisation)
Intended pH-value |
Measured pH-value at 50 °C |
4.0 ± 0.1 |
4.02 |
7.0 ± 0.1 |
7.00 |
9.0 ± 0.1 |
8.96 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The test item was found to be stable in the preliminary test at pH 4, 7 and 9 at 50 °C (Table 1). Reaction rate constants and half-lives could not be calculated due to the fact that the test item undergoes no significant hydrolysis. According to the guideline a half life of > 1 year under environmental conditions can be assumed.
- Executive summary:
Hydrolysis as a function of pH was determined according to OECD Guideline No. 111 and Council Regulation (EC) No. 440/2008, Method C.7 for the test item from 2013-05-17 to 2013-05-22 at Dr.U.Noack-Laboratorien, 31157 Sarstedt, Germany.
The study was conducted with test item concentrations of 1000 mg/L in buffer solutions at pH 4, 7 and 9 at a test temperature of 50 °C (preliminary test).
Samples were taken at test start (0 hours) and test end (120 hours) and analysed via HPLC with UV (DAD) detection on a reversed phase column using an external standard. Buffer solutions were analysed at test start and test end and indicated no interference with the test item. The analytical method for determination of the test item was validated and tested with satisfactory results in regard to linearity, accuracy, precision and specificity.
Degradation was calculated as the percentage loss of the test item over the time. In the preliminary test, the test item was found to be stable at pH 4, 7 and 9, respectively. No further testing was deemed necessary as less than 10 % of the applied test item was transformed after 120 hours (5 days) at a temperature of 50 °C and each of the three pH values. Reaction rate constants and half-lives could not be calculated because the test item undergoes no significant hydrolysis. With respect to the guidelines a half life of > 1 year could be assumed for environmental typical temperature conditions.
Degradation [%] of the test item at 50 °C after 120 Hours
Hydrolysis Time
[hours]
Degradation [%]
pH 4
pH 7
pH 9
120
7.34
0.99
6.67
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