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EC number: - | 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
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- 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
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- Nanomaterial agglomeration / aggregation
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- Nanomaterial pour density
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- Endpoint summary
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- 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
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- Toxicokinetics, metabolism and distribution
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- Irritation / corrosion
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- Repeated dose toxicity
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- Carcinogenicity
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- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Hydrolysis
Administrative data
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 January 2012 to 6 February 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in accordance with OECD and EU Guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- 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)
Test material
- Details on test material:
- Name: Reactive Red F08-0146
Constituent 1
- 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:
- Sampling: The reaction solutions were analysed at the start of the test and after suitable reaction periods. During the two slower experiments (pH 7 – 25 and 37°C) at each analytical occasion three tubes of test solution and 1 tube of control buffer were removed from the thermostat and analysed. At pH 7, 50°C control samples were analysed only at the start and at the end of the experiment.
In the investigations at pH 9, at defined time intervals, the flasks were removed from the thermostat and filled up with acetonitrile. Control samples were taken and analysed at the start and at the end of the experiment.
Analysis of the samples: Samples were diluted with acetonitrile to fit the calibrated range, then they were analysed using a HPLC method. - Buffers:
- Buffer solutions:
pH 7.0: 148 ml 0.2 M Sodium hydroxide and 250 ml 0.2 M Potassium dihydrogen phosphate were diluted to 1000 ml with ultra-pure water
pH 9.0: 107 ml 0.2 M Sodium hydroxide, 250 ml 0.2 M Boric acid and Potassium chloride were diluted to 1000 ml with ultra-pure water
These sterile buffer solutions were prepared using reagent grade chemicals and ultra-pure, sterile water.
The pH of each buffer solution was checked with a calibrated pH meter.
Buffer solution
for the eluent: 0.02 M Sodium dihydrogen phosphate with
0.005 M Disodium hydrogen phosphate
pH of this solution was adjusted to 6.3 with Phosphoric Acid. - Estimation method (if used):
- None
- Details on test conditions:
- Hydrolysis was examined at two pH values: 7.0 and 9.0 in the dark.
Test temperatures:
pH 7: 25 +/- 0.5°C, 37 +/- 0.5 degrees C and 50 +/- 0.5degrees C
pH 9: 10 +/- 0.5°C, 25 +/- 0.5°C and 37 +/- 0.5 degrees C
Light: The hydrolysis reaction was carried out using dark thermostats to avoid photolytic effects.
Oxygen: In order to exclude oxygen, nitrogen was bubbled into the water for five minutes before the preparation of the solutions at pH 7 (25 and 37°C). This step was omitted in case of the other, very fats tests.
Test solutions: The test item was dissolved in the buffer solutions. Test item concentration in the buffer solutions was approximately 2-10 µg/ml. The pH of each buffer solution was checked with a calibrated pH meter. In order to ensure sterility test solutions at pH 7 (25 and 37°C) were filtered on 0.22 µm membrane filter. It was impossible in case of the other tests, because of the very fast reaction.
Storage of the solutions: For the experiment at pH 7, solutions were transferred into screw capped tubes. 24 such tubes were prepared and incubated at 25°C, 37°C and 50°C.
In the experiments at pH 9 the hydrolysis occurred very fast. Therefore, aliquots were measured into seven flasks and placed in the thermostats. There was no time to prepare replicates; therefore the whole experiment was repeated twice at 10°C and 25°C and three times at 37°C.
Sterility confirmation: At the end of the experiments at pH 7 – 25 and 37°C, three replicate samples of the test solutions were submitted for sterility confirmation. The replicate samples were combined before the sterility testing. Samples were investigated using liquid culture media and the inoculated tubes were incubated at 30°C for seven days. After the incubation period the tubes were evaluated for the growth of microorganisms.
Growth of microorganisms was not detected.
In the other experiments sterility confirmation test was disregarded because of the fast reaction.
Duration of testopen allclose all
- Duration:
- 118 h
- pH:
- 7
- Initial conc. measured:
- 5.25 mg/L
- Duration:
- 32 h
- pH:
- 7
- Initial conc. measured:
- 5.25 mg/L
- Duration:
- 9 h
- pH:
- 7
- Initial conc. measured:
- 10.32 mg/L
- Duration:
- 12 min
- pH:
- 9
- Initial conc. measured:
- 3.24 mg/L
- Duration:
- 12 min
- pH:
- 9
- Initial conc. measured:
- 2.89 mg/L
- Duration:
- 20 min
- pH:
- 9
- Initial conc. measured:
- 3.28 mg/L
- Number of replicates:
- Two or three replicate samples were analysed at each time point.
In the experiments at pH 9 the hydrolysis occurred very fast. Therefore, aliquots were measured into seven flasks and placed in the thermostats. There was no time to prepare replicates; therefore the whole experiment was repeated twice at 10°C and 25°C and three times at 37°C. - Positive controls:
- no
- Negative controls:
- yes
- 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.
Results and discussion
- Preliminary study:
- Summary of the results of the preliminary test:
pH 4: Reactive Red F08-0146 proved to be hydrolytically stable
pH 7 and 9: Significant decomposition was observed. - Test performance:
- The test performed in accordance with the parameters specified in the test guidelines.
- Transformation products:
- yes
Identity of transformation productsopen allclose all
- No.:
- #1
Reference
- Reference substance name:
- Unnamed
- IUPAC name:
- see attachment
- No.:
- #2
Reference
- Reference substance name:
- Unnamed
- IUPAC name:
- see attachment
Total recovery of test substance (in %)open allclose all
- % Recovery:
- 36
- pH:
- 7
- Temp.:
- 25 °C
- Duration:
- 118 h
- % Recovery:
- 33
- pH:
- 7
- Temp.:
- 37 °C
- Duration:
- 32 h
- % Recovery:
- 36
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 9 h
- % Recovery:
- 12
- pH:
- 9
- Temp.:
- 10 °C
- Duration:
- 12 min
- % Recovery:
- 12
- pH:
- 9
- Temp.:
- 25 °C
- Duration:
- 12 min
- % Recovery:
- 10
- pH:
- 9
- Temp.:
- 37 °C
- Duration:
- 20 min
Dissipation DT50 of parent compoundopen allclose all
- pH:
- 7
- Temp.:
- 25 °C
- Hydrolysis rate constant:
- 0.009 h-1
- DT50:
- 76 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: regression coefficient = 0.987
- pH:
- 7
- Temp.:
- 37 °C
- Hydrolysis rate constant:
- 0.035 h-1
- DT50:
- 20 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: regression coefficient = 0.986
- pH:
- 7
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- 0.122 h-1
- DT50:
- 5.7 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: regression coefficient = 0.972
- pH:
- 9
- Temp.:
- 10 °C
- Hydrolysis rate constant:
- 0.176 min-1
- DT50:
- 4 min
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: regression coefficient = 0.998
- pH:
- 9
- Temp.:
- 25 °C
- Hydrolysis rate constant:
- 0.177 min-1
- DT50:
- 4 min
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: regression coefficient = 0.998
- pH:
- 9
- Temp.:
- 37 °C
- Hydrolysis rate constant:
- 0.116 min-1
- DT50:
- 6 min
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: regression coefficient = 0.976
- Other kinetic parameters:
- None
- Details on results:
- According to Sponsor’s experience, this hydrolysis product is most likely DYWJ 5653, for which no reference sample was available . The retention time of an other degradation product (9.2 min) confirms to the retention time of DYWJ 5660. Its amount corresponds to approximately 5-15% of the main hydrolysis product.
Any other information on results incl. tables
Measured data at pH 7
Temperature |
Sampling time, hour |
Measured concentration, µg/ml (mean of three) |
Hydrolysis rate, % |
Measured pH |
25°C |
Start |
5.25 |
- |
7.02 |
24 |
4.58 |
13 |
7.02 |
|
31 |
4.15 |
21 |
7.02 |
|
46 |
3.64 |
31 |
7.03 |
|
70 |
3.10 |
41 |
7.03 |
|
94 |
2.21 |
58 |
7.02 |
|
118 |
1.87 |
64 |
7.02 |
|
37°C |
Start |
5.25 |
- |
7.02 |
5 |
5.00 |
5 |
7.01 |
|
10 |
4.09 |
22 |
7.03 |
|
20 |
2.81 |
47 |
7.01 |
|
22 |
2.73 |
48 |
7.02 |
|
25 |
2.36 |
55 |
7.02 |
|
29 |
2.10 |
40 |
7.03 |
|
32 |
1.72 |
67 |
7.02 |
|
50°C |
Start |
10.32 |
- |
7.01 |
2 |
9.58 |
7 |
7.01 |
|
3 |
8.67 |
16 |
7.02 |
|
4 |
7.40 |
28 |
7.01 |
|
5 |
6.41 |
38 |
7.03 |
|
6 |
5.87 |
43 |
7.03 |
|
7 |
4.83 |
53 |
7.02 |
|
8 |
4.25 |
59 |
7.00 |
|
9 |
3.71 |
64 |
7.01 |
Measured data at pH 9
Temperature |
Sampling time, min |
Measured concentration, µg/ml |
Hydrolysis rate, % |
Measured pH |
10°C |
Start |
3.24* |
- |
9.06 |
2 |
2.34* |
28 |
- |
|
4 |
1.63* |
50 |
- |
|
6 |
1.18* |
64 |
- |
|
8 |
0.86* |
73 |
- |
|
10 |
0.57* |
82 |
- |
|
12 |
0.38* |
88 |
9.05 |
|
25°C |
Start |
2.89* |
- |
9.02 |
2 |
1.92* |
34 |
- |
|
4 |
1.45* |
50 |
- |
|
6 |
1.06* |
63 |
- |
|
8 |
0.69* |
76 |
- |
|
10 |
0.49* |
83 |
- |
|
12 |
0.34* |
88 |
9.03 |
|
37°C |
Start |
3.28** |
- |
9.01 |
2 |
2.50** |
24 |
- |
|
4 |
1.79** |
45 |
- |
|
6 |
1.17** |
64 |
- |
|
10 |
0.78** |
76 |
- |
|
15 |
0.51** |
84 |
- |
|
20 |
0.32** |
90 |
9.00 |
* Mean of two experiments
** Mean of three experiments
Calibration
The calibration series was prepared in acetonitrile : water (6:4). It was measured at each analytical occasion. Concentrations of the calibration samples were 0.1, 0.2, 0.5, 1, 2, 5 and 10 µg/ml. Parameters of three representative equations are given in the table below.
Regression data
Analytical occasion |
Intercept |
Slope |
Correlation Coefficient. |
02 February 2012 |
-634 |
8200 |
0.999 |
03 February 2012 |
-588 |
8394 |
1.000 |
04 February 2012 |
-598 |
8557 |
0.999 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Summary of the results:
pH Temperature t1/2
7 25°C 76 h
37°C 20 h
50°C 5.7 h
9 10°C < 10 min
25°C < 10 min
37°C < 10 min
According to Sponsor’s experience, this hydrolysis product is most likely DYWJ 5653, for which no reference sample was available . The retention time of an other degradation product (9.2 min) confirms to the retention time of DYWJ 5660. Its amount corresponds to approximately 5-15% of the main hydrolysis product. - Executive summary:
In the course of the hydrolysis preliminary test(10/285-336ANE) performed at 50°C, Reactive Red F08‑0146 proved to be hydrolytically stable at pH 4; but significant decomposition was observed at pH7 and 9. Therefore the purpose of this study was to perform the hydrolysis main test and evaluate the abiotic degradation of Reactive Red F08-0146 at pH7 and 9 at different temperatures.
This study has been performed in accordance with the study plan,OECD Guidelines for Testing of Chemicals (No. 111),Commission Regulation: Methods for the Determination of Ecotoxicity (C.7.)and the Principles of Good Laboratory Practice (Hungarian GLP Regulations: 9/2001. (III. 30.) EüM-FVM joint decree of the Minister of Health and the Minister of Agriculture and Regional Development which corresponds to the OECD GLP, ENV/MC/CHEM (98) 17.).
Summary of the results:
pH
Temperature
t1/2
7
25°C
76 h
37°C
20 h
50°C
5.7 h
9
10°C
< 10 min
25°C
< 10 min
37°C
< 10 min
According to Sponsor’s experience, this hydrolysis product is most likely DYWJ 5653, for which no reference sample was available . The retention time of an other degradation product (9.2 min) confirms to the retention time of DYWJ 5660. Its amount corresponds to approximately 5-15% of the main hydrolysis product.
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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