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EC number: 700-502-6 | 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:
- 2009-05-05 to 2009-06-26
- Reliability:
- 1 (reliable without restriction)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- not applicable
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
not applicable - Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
- Details on sampling:
- The test solutions were prepared by twofold dilution of the saturated stock solutions with the corresponding buffer solutions.
F 213 Red concentrations of the solutions were as follows:
In pH 4 buffer solution →1.28 mg/l, (≈7.2*10-4 mM),
in pH 7 buffer solution→1.85 mg/l, (≈1.0*10-3 mM),
in pH 9 buffer solution→2.15 mg/l, (≈1.2*10-3mM),
in pH 9 buffer solution→1.28 mg/l, (≈7.2*10-4 mM) for the hydrolysis at 55 C and at 67°C .
Additionally, control buffer samples were stored at each temperature.
The solutions were stored in screw-cap glass tubes with PTFE septa. Volume of the tubes was 15 ml.
From pH 7 and pH 9 buffer solutions 30 such tubes were placed in the thermostate; from pH 4 solution 6 tubes were stored.
Three tubes were analysed for each temperature in time intervals which provided a minimum of six spaced data points between 10 % and 90 %
hydrolysis of the F 213 Red.
Three samples were analysed from three separate tubes at all analytical occasion of hydrolysis test. Sample volume was 0.8 ml, and this was diluted to 1ml with dilution mixture. One sample was taken from the control vessel and it was directly injected. The pH of each buffer solution was checked with a calibrated pH meter. - Buffers:
- Buffer Solution: 5 mM Hexane-1-sulfonic acid sodium salt; 15 mM Potassium dihydrogen phosphate, pH=3 with Phosphoric acid 85 %
- Estimation method (if used):
- not applicable
- Details on test conditions:
- The hydrolysis was examined in different buffer solutions.
Temperature: 50 °C ± 0.5 °C, 55 °C ± 0.5 °C, 67 °C ± 0.5 °C.
Light and oxygen: The hydrolysis reaction was carried out using a dark thermostat to avoid photolytic effects. Nitrogen was bubbled into the water for five minutes before the preparation of the solutions in order to exclude oxygen.
All glassware, water and buffer solution were sterilised.
Duration of testopen allclose all
- Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 1.28 mg/L
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 1.85 mg/L
- Duration:
- 72 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 2.15 mg/L
- Duration:
- 24 h
- pH:
- 9
- Temp.:
- 55 °C
- Initial conc. measured:
- 1.28 mg/L
- Duration:
- 10 h
- pH:
- 9
- Temp.:
- 67 °C
- Initial conc. measured:
- 1.28 mg/L
- Number of replicates:
- Three replicates.
- Positive controls:
- no
- Negative controls:
- yes
- Remarks:
- Control buffers assessed at each pH both after 2.4 hours and 5 days
- Statistical methods:
- The chromatograms were evaluated with the help of “LaChrom Chromatogram Processor".
Calculations were carried out using “EXCEL for Windows". The calibration curves were constructed with “STATISTICA for Windows" using weighted linear regression. The factor was 1/concentration.
For pseudo-first order the rate constant (kobs) was determined from the plots of the natural logarithm (ln) of the concentration versus time: (eq. 2 and 3).
lntkCCt*0= (eq. 1)
ln Ct = ln C0 – k *t (eq. 2)
kobs = –slope (eq. 3)
obskt2ln21= (eq. 4)
where t time
t 1/2 half-life period
C0 start concentration
Ct concentration at time point “t”
Applying the Arrhenius equation the rate constant and half-life were calculated at 25°C from the plot of ln k versus 1/T:
ln k = (-E/R*T) + lnA
where E activation energy [kJ/mol]
T absolute temperature [K]
R gas constant [8.314 J/mol*K]
A A-factor, empirical constant
Results and discussion
- Preliminary study:
- The content of F 213 Red in the different pH buffer samples was determined at the beginning, after 2.4 hours and the end of the test periods.
Three samples were analysed from three separate tubes at the start of hydrolysis test, after 2.4 hours and after 120 hours. Sample volume of 1 ml was diluted twofold with dilution mixture at the start of study and after 2.4 hours. On the end of preliminary test the sample volume of 1.6 ml was diluted to 2 ml. If the preliminary test indicates that 50% or more of the test substance has been hydrolysed in 2.4 hours at 50 °C, or less than 10 % has been hydrolysed after 5 days at each of the three pH values (4, 7 and 9), no further testing is necessary.
The concentration of F 213 Red decreased at pH 4 by 18 % and 62 % , at pH 7 by 23 % and 76 % , and at pH 9 by 19 % and more than 90 % after 2.4 hours resp. after 5 days at 50°C. Based on the results obtained, test substance F 213 Red can be considered as hydrolytically unstable at pH 4, pH 7 and pH 9. Thus, additionally a main study was performed at each of the three pH values. - Test performance:
- not applicable
- Transformation products:
- not measured
Total recovery of test substance (in %)open allclose all
- % Recovery:
- 98
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 120 h
- % Recovery:
- 94
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 120 h
- % Recovery:
- 14
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 72 h
- % Recovery:
- 33
- pH:
- 9
- Temp.:
- 55 °C
- Duration:
- 24 h
- % Recovery:
- 26
- pH:
- 9
- Temp.:
- 67 °C
- Duration:
- 10 h
Dissipation DT50 of parent compoundopen allclose all
- pH:
- 9
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- 0.03 h-1
- DT50:
- 25 h
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 9
- Temp.:
- 55 °C
- Hydrolysis rate constant:
- 0.05 h-1
- DT50:
- 15 h
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 9
- Temp.:
- 67 °C
- Hydrolysis rate constant:
- 0.13 h-1
- DT50:
- 5 h
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 9
- Temp.:
- 25 °C
- Hydrolysis rate constant:
- 0 h-1
- DT50:
- 14 d
- Type:
- (pseudo-)first order (= half-life)
- Other kinetic parameters:
- not applicable
- Details on results:
- not applicable
Any other information on results incl. tables
Measured data at a temperature of 50 °C at the pH4
pH |
Sampling time. hour |
Concentration of F 213 Red, mg/l |
Rate. % |
Measured pH |
|
Test vessels |
Mean with the 95% confidence intervals |
Hydrolysis % |
|||
4 |
Start |
1.28 |
1.28±0.02 |
- |
4.02 |
1.28 |
|||||
1.30 |
|||||
Control buffer |
4.02 |
||||
120 |
1.27 |
1.26±0.03 |
2 |
4.02 |
|
1.26 |
4.02 |
||||
1.25 |
4.02 |
||||
Control buffer |
4.00 |
Measured data at a temperature of 50 °C at the pH 7
pH |
Sampling time. hour |
F 213 Red concentration, mg/l |
Hydrolysis % |
Measured pH |
||||
Test vessels |
Mean with the 95% confidence intervals |
|||||||
7 |
Start |
1.82 |
1.85±0.07 |
- |
6.99 |
|||
1.84 |
||||||||
1.88 |
||||||||
Control buffer |
6.98 |
|||||||
72 |
1.80 |
1.80±0.06 |
2 |
7.00 |
||||
1.78 |
7.00 |
|||||||
1.83 |
7.01 |
|||||||
Control buffer |
7.00 |
|||||||
120 |
1.69 |
1.74±0.10 |
6 |
7.02 |
||||
1.77 |
7.02 |
|||||||
1.76 |
7.02 |
|||||||
Control buffer |
7.01 |
Measured data at a temperature of 50 °C at pH 9
Temperature |
Time |
F 213 Red concentration, mg/l |
Hydrolysis % |
Measured pH |
|
Test vessels |
Mean with the 95% confidence intervals |
||||
50 |
Start |
2.16 |
2.15±0.06 |
- |
9.01 |
2.17 |
|||||
2.12 |
|||||
Control buffer |
9.00 |
||||
4 |
2.01 |
2.04±0.07 |
5 |
9.00 |
|
2.06 |
9.01 |
||||
2.06 |
9.01 |
||||
Control buffer |
9.01 |
||||
6 |
1.95 |
1.90±0.10 |
12 |
9.02 |
|
1.87 |
9.02 |
||||
1.88 |
9.02 |
||||
Control buffer |
9.01 |
||||
8 |
1.79 |
1.86±0.17 |
14 |
9.02 |
|
1.91 |
9.02 |
||||
1.88 |
9.02 |
||||
Control buffer |
9.02 |
||||
11 |
1.60 |
1.65±0.11 |
23 |
9.01 |
|
1.69 |
9.02 |
||||
1.66 |
9.01 |
||||
Control buffer |
9.01 |
||||
13 |
1.55 |
1.58±0.07 |
27 |
9.02 |
|
1.58 |
9.02 |
||||
1.60 |
9.01 |
||||
Control buffer |
9.01 |
||||
15 |
1.49 |
1.47±0.07 |
32 |
9.01 |
|
1.44 |
9.01 |
||||
1.46 |
9.01 |
||||
Control buffer |
9.01 |
Temperature |
Time |
F 213 Red concentration, mg/l |
Hydrolysis % |
Measured pH |
|
In the Samples |
Meanwith the 95% confidence intervals |
||||
50 |
24 |
1.12 |
1.15±0.07 |
46 |
9.02 |
1.16 |
9.02 |
||||
1.18 |
9.02 |
||||
Control buffer |
9.01 |
||||
29 |
1.01 |
1.02±0.05 |
53 |
9.02 |
|
1.01 |
9.01 |
||||
1.04 |
9.02 |
||||
Control buffer |
9.02 |
||||
34 |
0,84 |
0.88±0.09 |
59 |
9.02 |
|
0.89 |
9.02 |
||||
0.91 |
9.02 |
||||
Control buffer |
9.01 |
||||
72 |
0.30 |
0.30±0.02 |
86 |
9.02 |
|
0.31 |
9.02 |
||||
0.31 |
9.01 |
||||
Control buffer |
9.01 |
Measured data atpH 9at 55± 0.5 °C
Temperature |
Time |
F 213 Red, mg/l |
Hydrolysis % |
Measured pH |
|
In the Samples |
Mean with the 95% confidence intervals |
||||
55 |
Start |
1.34 |
1.28±0.15 |
- |
9.02 |
1.26 |
|||||
1.23 |
|||||
Control buffer |
9.02 |
||||
1 |
1.20 |
1.17±0.06 |
8 |
9.03 |
|
1.18 |
9.04 |
||||
1.15 |
9.02 |
||||
Control buffer |
9.04 |
||||
2 |
1.13 |
1.16±0.08 |
9 |
9.04 |
|
1.19 |
9.01 |
||||
1.15 |
9.03 |
||||
Control buffer |
9.04 |
||||
3 |
1.11 |
1.08±0.06 |
15 |
9.02 |
|
1.08 |
9.04 |
||||
1.06 |
9.02 |
||||
Control buffer |
9.03 |
||||
5 |
1.04 |
1.04±0.02 |
18 |
9.03 |
|
1.06 |
9.03 |
||||
1.04 |
9.04 |
||||
Control buffer |
9.04 |
||||
7 |
0.96 |
0.92±0.08 |
28 |
9.05 |
|
0.92 |
9.02 |
||||
0.89 |
9.04 |
||||
Control buffer |
9.04 |
||||
8 |
0.89 |
0.85±0.14 |
34 |
9.03 |
|
0.86 |
9.02 |
||||
0.78 |
9.04 |
||||
Control buffer |
9.01 |
Temperature |
Time |
F 213 Red, mg/l |
Hydrolysis % |
Measured pH |
|
In the Samples |
Mean with the 95% confidence intervals |
||||
55 |
9 |
0.84 |
0.84±0.02 |
35 |
9.01 |
0.83 |
9.02 |
||||
0.83 |
9.03 |
||||
Control buffer |
9.04 |
||||
10 |
0.80 |
0.78±0.05 |
39 |
9.04 |
|
0.76 |
9.03 |
||||
0.79 |
9.01 |
||||
Control buffer |
9.03 |
||||
12 |
0.75 |
0.74±0.06 |
42 |
9.02 |
|
0.71 |
9.02 |
||||
0.75 |
9.03 |
||||
Control buffer |
9.03 |
||||
24 |
0.41 |
0.42±0.02 |
67 |
9.02 |
|
0.43 |
9.04 |
||||
0.41 |
9.05 |
||||
Control buffer |
9.01 |
Measured data atpH 9at67±0.5 °C
Temperature |
Time |
F 213 Red, mg/l |
Hydrolysis % |
Measured pH |
|
In the Samples |
Mean with the 95% confidence intervals |
||||
67 |
Start |
1.34 |
1.28±0.15 |
- |
9.02 |
1.26 |
|||||
1.23 |
|||||
Control buffer |
9.02 |
||||
1 |
1.22 |
1.18±0.11 |
8 |
9.03 |
|
1.17 |
9.03 |
||||
1.13 |
9.02 |
||||
Control buffer |
9.04 |
||||
2 |
1.13 |
1.09±0.13 |
14 |
9.05 |
|
1.06 |
9.02 |
||||
- |
9.03 |
||||
Control buffer |
9.04 |
||||
3 |
0.97 |
1.00±0.09 |
22 |
9.01 |
|
1.04 |
9.03 |
||||
0.98 |
9.02 |
||||
Control buffer |
9.03 |
||||
4 |
0.89 |
0.88±0.03 |
31 |
9.03 |
|
0.87 |
9.02 |
||||
0.89 |
9.03 |
||||
Control buffer |
9.03 |
||||
5 |
0.74 |
0.74±0.01 |
42 |
9.04 |
|
0.73 |
9.03 |
||||
0.74 |
9.04 |
||||
Control buffer |
9.02 |
||||
6 |
0.63 |
0.64±0.01 |
50 |
9.03 |
|
0.64 |
9.02 |
||||
0.64 |
9.03 |
||||
Control buffer |
9.04 |
Temperature |
Time |
F 213 Red, mg/l |
Hydrolysis % |
Measured pH |
|
In the Samples |
Mean with the 95% confidence intervals |
||||
67 |
7 |
0.53 |
0.55±0.05 |
57 |
9.02 |
0.57 |
9.02 |
||||
0.54 |
9.05 |
||||
Control buffer |
9.03 |
||||
8 |
0.45 |
0.47±0.03 |
63 |
9.01 |
|
0.48 |
9.03 |
||||
0.47 |
9.04 |
||||
Control buffer |
9.04 |
||||
9 |
0.43 |
0.43±0.01 |
66 |
9.04 |
|
0.43 |
9.03 |
||||
0.43 |
9.03 |
||||
Control buffer |
9.04 |
||||
10 |
0.33 |
0.34±0.12 |
74 |
9.02 |
|
0.39 |
9.02 |
||||
0.29 |
9.03 |
||||
Control buffer |
9.03 |
Rate constants and half-lives calculated at 25°C
Temperature, °C |
pH |
kobs |
t1/2 |
25 |
9 |
0.002 |
14 days(344 hours) |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- not applicable
- Conclusions:
- pH 7 at 25 °C, t 1/2: > 1 year
pH4 at 25 °C, t 1/2: > 1 year
pH9 at 25 °C, t 1/2: 14 days (344 hours)
ph 9 at 50 °C, t 1/2: 25 hours - Executive summary:
The purpose of this study was to evaluate the hydrolysis of F 213 Red in different pH buffer solutions.
The hydrolysis of F 213 Red was observed less than 10 per cent after 5 days (which means T1/2 > 1 year at 25°C) in buffer solutions pH 4 and pH 7, therefore the test item is considered to be hydrolytically stable under the conditions investigated.
The calculated half lives of the hydrolysis reactions at pH 9 are 14 days at 25 °C and 25 hours at 50 °C.
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