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Hydrolysis
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 May 2012 to 18 June 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study with GLP certificate conducted in accordance with OECD Guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- Name: Reactive Red F03-0318
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:
- Test solutions: The test item was dissolved in the buffer solutions. Test item concentration in the buffer solutions was approximately 100 µg/ml. The pH of each buffer solution was checked with a calibrated pH meter. In order to ensure sterility test solutions were filtered on 0.22 µm membrane filter.
Sampling: The reaction solutions were analysed at the start of the test and after suitable reaction periods. At each analytical occasion three tubes of test solution and 1 tube of control buffer were removed from the thermostat and analysed.
Analysis of the samples: Samples were diluted with eluent buffer to fit the calibrated range, then they were analysed with the HPLC method described below.
Sterility confirmation: At the end of the experiments 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 - Buffers:
- Buffer solution for the eluent: 45 mM Sodium dihydrogen phosphate with 5 mM Disodium hydrogen phosphate.
Buffer solutions:
pH 4.0: 4 ml 0.2 M Sodium hydroxide and 500 ml 0.2 M Potassium hydrogen phtalate were diluted to 2000 ml with ultra-pure water
pH 7.0: 295.6 ml 0.2 M Sodium hydroxide and 500 ml 0.2 M Potassium dihydrogen phosphate were diluted to 2000 ml with ultra-pure water
pH 9.0: 214 ml 0.2 M Sodium hydroxide, 500 ml 0.2 M Boric acid and Potassium chloride were diluted to 2000 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. - Estimation method (if used):
- None
- Details on test conditions:
- TEST CONDITIONS
pH: Hydrolysis was examined at three pH values: 4.0, 7.0 and 9.0 in the dark.
Buffer solutions:
pH 4.0 :4 ml 0.2 M Sodium hydroxide and 500 ml 0.2 M Potassium hydrogen phtalate were diluted to 2000 ml with ultra-pure water
pH 7.0: 295.6 ml 0.2 M Sodium hydroxide and 500 ml 0.2 M Potassium dihydrogen phosphate were diluted to 2000 ml with ultra-pure water
pH 9.0: 214 ml 0.2 M Sodium hydroxide, 500 ml 0.2 M Boric acid and Potassium chloride were diluted to 2000 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.
Test temperatures: 25 +/- 0.5°C, 37 +/- 0.5°C and 50 +/- 0.5°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.
Duration of testopen allclose all
- Duration:
- 192 h
- pH:
- 4
- Initial conc. measured:
- 103 500 µg/L
- Duration:
- 71 h
- pH:
- 4
- Initial conc. measured:
- 113 000 µg/L
- Duration:
- 23 h
- pH:
- 4
- Initial conc. measured:
- 107 000 µg/L
- Duration:
- 289 h
- pH:
- 7
- Initial conc. measured:
- 114 000 µg/L
- Duration:
- 71 h
- pH:
- 7
- Initial conc. measured:
- 127 000 µg/L
- Duration:
- 23 h
- pH:
- 7
- Initial conc. measured:
- 109 200 µg/L
- Duration:
- 5 h
- pH:
- 9
- Initial conc. measured:
- 99 800 µg/L
- Duration:
- 2 h
- pH:
- 9
- Initial conc. measured:
- 113 200 µg/L
- Duration:
- 1.75 h
- pH:
- 9
- Initial conc. measured:
- 108 900 µg/L
- Number of replicates:
- At each analytical occasion three tubes of test solution and 1 tube of control buffer were removed from the thermostat and analysed
- Positive controls:
- no
- Negative controls:
- yes
- Statistical methods:
- Evaluation: 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.
The rate constant (kobs) for each pH value and both temperatures of the tests were determined from the plots of the logarithms of the concentration versus time.
Results and discussion
- Preliminary study:
- In the course of the preliminary test significant decomposition of REACTIVE RED F03-0318 was observed at pH 4, 7 and 9; less than 2% of the original concentration was measured after 120 hours. See Hydrolysis supporting study for details.
- Test performance:
- The test was considered to be valid - see results of method validation below.
- Transformation products:
- yes
Identity of transformation productsopen allclose all
- Details on hydrolysis and appearance of transformation product(s):
- At the end of the study, solutions of the most likely degradation products, DYKJ 5305, DYDJ 5310, DYDJ 5312 and DYDJ 5313 (provided by the Sponsor) were also injected in the series of the test samples in order to confirm the identity of the degradation products.
At pH 7 and pH 9 retention time of the main hydrolysis product (11.0 min) significantly deviates from the retention time of the above standards. Its amount corresponds to approximately 50-77% of the main hydrolysis product.
According to Sponsor’s experience and according to the Certificate of Analysis, this hydrolysis product is most likely the vinylated form of the dye, for which no reference sample was available. This compound is the intended hydrolysis product and the virtual dyeing component during the dyeing process, which takes place at alkaline pH at about 60°C.
Main component of the provided standards elutes at different retention times: DYDJ 5313 (7.4 min), DYDJ 5310 (8.6 min), DYKJ 5305 (8.9 min) DYDJ 5312 (12.1 min). Therefore, identity of the main hydrolysis product was not supported by this experiment.
However, the retention time of a main hydrolysis product at pH 4 confirms to the retention time of DYDJ 5310. Its amount corresponds to approximately 65-74% of the main hydrolysis product.
The structures of the main hydrolysis products are attached under background material.
Total recovery of test substance (in %)open allclose all
- % Recovery:
- 21
- pH:
- 4
- Temp.:
- 25 °C
- Duration:
- 192 h
- % Recovery:
- 11
- pH:
- 4
- Temp.:
- 37 °C
- Duration:
- 71 h
- % Recovery:
- 24
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 23 h
- % Recovery:
- 34
- pH:
- 7
- Temp.:
- 25 °C
- Duration:
- 289 h
- % Recovery:
- 15
- pH:
- 7
- Temp.:
- 37 °C
- Duration:
- 71 h
- % Recovery:
- 14
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 23 h
- % Recovery:
- 28
- pH:
- 9
- Temp.:
- 25 °C
- Duration:
- 5 h
- % Recovery:
- 15
- pH:
- 9
- Temp.:
- 37 °C
- Duration:
- 2 h
- % Recovery:
- 12
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 1.75 h
Dissipation DT50 of parent compoundopen allclose all
- pH:
- 4
- Temp.:
- 25 °C
- Hydrolysis rate constant:
- 0.009 h-1
- DT50:
- 79 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: regression coefficient = 0.995
- pH:
- 4
- Temp.:
- 37 °C
- Hydrolysis rate constant:
- 0.031 h-1
- DT50:
- 22 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: Regression coefficient = 0.995
- pH:
- 4
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- 0.064 h-1
- DT50:
- 11 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: Regression coefficient = 0.988
- pH:
- 7
- Temp.:
- 25 °C
- Hydrolysis rate constant:
- 0.004 h-1
- DT50:
- 176 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: Regression coefficient = 0.989
- pH:
- 7
- Temp.:
- 37 °C
- Hydrolysis rate constant:
- 0.028 h-1
- DT50:
- 25 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: Regression coefficient = 0.994
- pH:
- 7
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- 0.088 h-1
- DT50:
- 8 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: Regression coefficient = 0.975
- pH:
- 9
- Temp.:
- 25 °C
- Hydrolysis rate constant:
- 0.259 h-1
- DT50:
- 2.7 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: Regression coefficient = 0.999
- pH:
- 9
- Temp.:
- 37 °C
- Hydrolysis rate constant:
- 0.976 h-1
- DT50:
- 0.7 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: Regression coefficient = 0.963
- pH:
- 9
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- 1.213 h-1
- DT50:
- 0.6 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: Regression coefficient = 0.930
- Other kinetic parameters:
- None
- Details on results:
- See below for results of the method validation.
At the end of the study, solutions of the most likely degradation products, DYKJ 5305, DYDJ 5310, DYDJ 5312 and DYDJ 5313 (provided by the Sponsor) were also injected in the series of the test samples in order to confirm the identity of the degradation products.
At pH 7 and pH 9 retention time of the main hydrolysis product (11.0 min) significantly deviates from the retention time of the above standards. Its amount corresponds to approximately 50-77% of the main hydrolysis product.
According to Sponsor’s experience and according to the Certificate of Analysis, this hydrolysis product is most likely the vinylated form of the dye, for which no reference sample was available. This compound is the intended hydrolysis product and the virtual dyeing component during the dyeing process, which takes place at alkaline pH at about 60°C.
Main component of the provided standards elutes at different retention times: DYDJ 5313 (7.4 min), DYDJ 5310 (8.6 min), DYKJ 5305 (8.9 min) DYDJ 5312 (12.1 min). Therefore, identity of the main hydrolysis product was not supported by this experiment.
However, the retention time of a main hydrolysis product at pH 4 confirms to the retention time of DYDJ 5310. Its amount corresponds to approximately 65-74% of the main hydrolysis product.
Any other information on results incl. tables
Table 1.: Results of the Method Validation (11/008-316AN)
Selectivity |
No interfering component was observed |
Reinjection repeatability |
Coefficient of Variation<2% |
Linear range |
0.1 - 10 µg/ml |
Limit of Quantification |
0.1µg/ml |
Recovery frombuffer solutions |
94 – 103% |
Stability of the samples |
At least 22 hours in the autosampler |
Stock solution stability |
At least 14 days at 5±3°C, in the dark |
The calibration series was prepared in eluent buffer.It wasmeasured 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 Table 2.
Table 2: Regression data
Analytical occasion |
Intercept |
Slope |
Correlation Coefficient. |
04 June 2012 |
-187 |
10044 |
1.000 |
06 June 2012 |
-211 |
10346 |
1.000 |
07 June 2012 |
-52 |
9980 |
1.000 |
08 June 2012 |
-79 |
9519 |
1.000 |
09 June 2012 |
-121 |
10390 |
1.000 |
10 June 2012 |
-227 |
9665 |
1.000 |
11 June 2012 |
-59 |
9443 |
1.000 |
12 June 2012 |
74 |
10271 |
1.000 |
13 June 2012 |
53 |
9908 |
1.000 |
14 June 2012 |
55 |
9433 |
1.000 |
18 June 2012 |
334 |
10051 |
0.999 |
Table 3: Measured data at pH 4
Temperature |
Sampling time, hour |
Measured concentration, µg/ml (mean of three) |
Hydrolysis rate, % |
Measured pH |
25°C |
Start |
103.5 |
- |
4.03 |
24 |
89.9 |
13 |
4.03 |
|
29 |
85.1 |
18 |
4.02 |
|
46 |
77.2 |
25 |
4.03 |
|
72 |
59.2 |
43 |
4.05 |
|
96 |
49.9 |
52 |
4.05 |
|
120 |
40.1 |
61 |
4.05 |
|
144 |
30.3 |
71 |
4.05 |
|
192 |
21.5 |
79 |
4.05 |
|
37°C |
Start |
113 |
- |
4.01 |
10 |
94.0 |
17 |
4.02 |
|
22 |
57.7 |
49 |
4.03 |
|
26 |
50.2 |
56 |
4.03 |
|
34 |
43.0 |
62 |
4.03 |
|
46 |
26.9 |
76 |
|
|
53 |
23.5 |
79 |
4.02 |
|
71 |
12.9 |
89 |
4.03 |
|
50°C |
Start |
107 |
- |
4.05 |
4 |
89.9 |
16 |
4.04 |
|
6 |
81.2 |
24 |
4.03 |
|
8 |
75.0 |
30 |
4.03 |
|
10 |
60.6 |
43 |
4.03 |
|
12 |
54.3 |
49 |
4.02 |
|
14 |
49.2 |
54 |
4.03 |
|
23 |
25.4 |
76 |
4.02 |
Table 4: Measured data at pH 7
Temperature |
Sampling time, hour |
Measured concentration, µg/ml |
Hydrolysis rate, % |
Measured pH |
25°C |
Start |
114 |
- |
6.97 |
46 |
100 |
12 |
7.03 |
|
72 |
87.9 |
23 |
7.02 |
|
96 |
82.0 |
28 |
7.05 |
|
144 |
65.4 |
43 |
7.04 |
|
192 |
59.9 |
48 |
7.04 |
|
289 |
36.9 |
68 |
7.04 |
|
37°C |
Start |
127 |
- |
7.02 |
10 |
105 |
18 |
7.03 |
|
22 |
75.9 |
40 |
7.03 |
|
26 |
58.4 |
54 |
7.03 |
|
34 |
52.5 |
59 |
7.03 |
|
46 |
35.8 |
72 |
7.05 |
|
53 |
30.9 |
76 |
7.02 |
|
71 |
18.7 |
85 |
7.03 |
|
50°C |
Start |
109.2 |
- |
7.02 |
4 |
90.7 |
17 |
7.01 |
|
6 |
78.7 |
28 |
7.03 |
|
8 |
71.6 |
34 |
7.02 |
|
10 |
56.8 |
48 |
7.02 |
|
12 |
44.8 |
59 |
7.02 |
|
14 |
40.3 |
63 |
7.04 |
|
23 |
14.9 |
86 |
7.03 |
Table 5: Measured data at pH 9
Temperature |
Sampling time, hour |
Measured concentration, µg/ml |
Hydrolysis rate, % |
Measured pH |
25°C |
Start |
99.8 |
- |
9.05 |
1 |
79.0 |
21 |
9.04 |
|
2 |
60.8 |
39 |
9.05 |
|
2.5 |
54.3 |
46 |
9.04 |
|
3 |
46.4 |
54 |
9.05 |
|
3.5 |
40.9 |
59 |
9.05 |
|
4 |
36.3 |
64 |
9.05 |
|
4.5 |
31.7 |
68 |
9.02 |
|
5 |
27.6 |
72 |
9.04 |
|
37°C |
Start |
113.2 |
- |
9.06 |
0.5 |
87.6 |
23 |
9.05 |
|
0.75 |
74.5 |
34 |
9.06 |
|
1 |
58.1 |
49 |
9.05 |
|
1.25 |
47.5 |
58 |
9.06 |
|
1.5 |
32.1 |
72 |
9.05 |
|
1.75 |
23.4 |
79 |
9.07 |
|
2 |
17.0 |
85 |
9.05 |
|
50°C |
Start |
108.9 |
- |
8.97 |
0.25 |
90.2 |
17 |
8.96 |
|
0.75 |
65.6 |
40 |
8.94 |
|
1 |
50.8 |
53 |
8.96 |
|
1.25 |
35.0 |
68 |
8.98 |
|
1.5 |
16.9 |
84 |
8.96 |
|
1.75 |
13.4 |
88 |
8.97 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- At the end of the study, solutions of the most likely degradation products, DYDJ 5305, DYDJ 5310, DYDJ 5312 and DYDJ 5313 (provided by the Sponsor) were also injected in the series of the test samples in order to confirm the identity of the degradation products.
In the course of the hydrolysis preliminary test (11/008-336ANE) performed at 50°C, significant decomposition was observed at pH 4,7 and 9. Therefore the purpose of this study was to perform the hydrolysis main test and evaluate the abiotic degradation of Reactive Red F03-0318 at pH 4,7 and 9 at different temperatures.
At pH 7 and pH 9 retention time of the main hydrolysis product (11.0 min) significantly deviates from the retention time of the above standards. Its amount corresponds to approximately 50-77% of the main hydrolysis product. Main component of the provided standards elutes at different retention times: DYDJ 5313 (7.4 min), DYDJ 5310 (8.6 min), DYDJ 5305 (8.9 min) DYDJ 5312 (12.1 min). Therefore, identity of the main hydrolysis product was not supported by this experiment. However, the retention time of a main hydrolysis product at pH 4 confirms to the retention time of DYDJ 5310. Its amount corresponds to approximately 65-74% of the main hydrolysis product. - Executive summary:
In the course of the hydrolysis preliminary test (11/008-336ANE) performed at 50°C, significant decomposition was observed at pH 4,7 and 9. Therefore the purpose of this study was to perform the hydrolysis main test and evaluate the abiotic degradation of Reactive Red F03-0318 at pH 4,7 and 9 at different temperatures.
Rate constants and half-lives based on the measured data
pH
Temperature
Slope
kobs
t1/2
regression coefficient
4
25°C
-0.0038
0.0088
79 h
0.995
37°C
-0.0135
0.0311
22 h
0.995
50°C
-0.0277
0.0637
11 h
0.988
7
25°C
-0.0017
0.0039
176 h
0.989
37°C
-0.0120
0.0276
25 h
0.994
50°C
-0.0384
0.0885
8 h
0.975
9
25°C
-0.1122
0.2585
2.7 h
0.999
37°C
-0.4239
0.9764
0.7 h
0.963
50°C
-0.5268
1.2133
0.6 h
0.930
At the end of the study, solutions of the most likely degradation products, DYDJ 5305, DYDJ 5310, DYDJ 5312 and DYDJ 5313 (provided by the Sponsor) were also injected in the series of the test samples in order to confirm the identity of the degradation products.
At pH 7 and pH 9 retention time of the main hydrolysis product (11.0 min) significantly deviates from the retention time of the above standards. Its amount corresponds to approximately 50-77% of the main hydrolysis product. Main component of the provided standards elutes at different retention times: DYDJ 5313 (7.4 min), DYDJ 5310 (8.6 min), DYDJ 5305 (8.9 min) DYDJ 5312 (12.1 min). Therefore, identity of the main hydrolysis product was not supported by this experiment. However, the retention time of a main hydrolysis product at pH 4 confirms to the retention time of DYDJ 5310. Its amount corresponds to approximately 65-74% 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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