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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
- 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
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
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- Toxicity to microorganisms
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Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 18 May 2017 to 24 July 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Hygroscopic: store in ziplock bag
Water solubility ≥ 330.94 g/L at 20°C - Analytical monitoring:
- yes
- Buffers:
- Acetate buffer pH4, 0.1M: solution of 0.1M acetic acid adjusted to pH4 using 10N sodium hydroxide. The buffer contains 0.002% (w/) T203.
Phosphate buffer pH7, 0.1M: solution of 0.1M potassium dihydrogenphosphate adjusted to pH7 using 10N sodium hydroxide. The buffer contains 0.002% (w/v) T203.
Borate buffer pH9, 0.1M: solution of 0.1M boric acid and 0.1M potassium chloride adjusted to pH9 using 10N sodium hydroxide. The buffer contains 0.002% (w/v) T203. - Details on test conditions:
- During the main study of the determination of the Hydrolysis as a function of pH7, pH4 and pH9 at 20°C, the temperature was controlled within ± 0.8°C (criterion was ±0.5°C).
Evaluation: The temperature range was slightly higher than the criterion. According to this it was considered not to significantly influence the degradation of the test substance at 20°C.
The study integrity was not adversely affected by the deviations.
Any deviations from standard operating procedures (SOPs) were evaluated and filed in the study file. There were no deviations from SOPs that affected the integrity of the study. - Duration:
- 168 h
- pH:
- 4
- Temp.:
- 20 °C
- Initial conc. measured:
- 510 mg/L
- Duration:
- 168 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 527 mg/L
- Duration:
- 168 h
- pH:
- 7
- Temp.:
- 20 °C
- Initial conc. measured:
- 503 mg/L
- Duration:
- 168 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 500 mg/L
- Duration:
- 168 h
- pH:
- 9
- Temp.:
- 20 °C
- Initial conc. measured:
- 517 mg/L
- Duration:
- 168 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 500 mg/L
- Number of replicates:
- 2
- Test performance:
- The rate of hydrolysis of the test substance as a function of pH was determined at pH values normally found in the environment (pH4-9).
The buffer solutions were filter-sterilised through a 0.22µm PVDF filter (Merck Millipore Ltd.) and transferred into a sterile vessel. The test substance was spiked to the solutions at a target concentration of 1000 mg/l using a spiking solution in water. For each sampling time, duplicate sterile vessels under vacuum were filled with 20mL test solution.
The concentration of the test substance in the test samples was determined immediately after preparation (t=0) and at several sampling points after t=0. The samples after t=0 days were cooled to room temperature using running tap water, if necessary.
The samples not analysed on the sampling day were stored in the freezer. Storage stability under these conditions was determined by the analysis of additional accuracy samples prepared at half the nominal concentration of the test samples. On the days of analysis, the frozen samples were defrosted at room temperature, treated and analysed. The stored samples were found to be stable if the mean accuracy was in the range 70-110%. Based on the results obtained the samples were stable when stored in the freezer for 7 days (results are archived in the raw data).
Blank buffer solutions were treated similarly as the test samples and analysed at t=0.
The pH of each of the test solutions (except for the blanks) was determined at least at the beginning and at the end of the test. - Transformation products:
- no
- % Recovery:
- ca. 100
- pH:
- 4
- Temp.:
- 20 °C
- Duration:
- 168 h
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- ca. 100
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 168 h
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- 97.2
- pH:
- 7
- Temp.:
- 20 °C
- Duration:
- 168 h
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- 97.7
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 168 h
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- 98.6
- pH:
- 9
- Temp.:
- 20 °C
- Duration:
- 168 h
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- 95
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 168 h
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 4
- Temp.:
- 20 °C
- Hydrolysis rate constant:
- 0.001 h-1
- DT50:
- 29.6 d
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 4
- Temp.:
- 25 °C
- Hydrolysis rate constant:
- 0.001 h-1
- DT50:
- 24.2 d
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 4
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- 0.003 h-1
- DT50:
- 9.87 d
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 7
- Temp.:
- 20 °C
- Hydrolysis rate constant:
- 0 h-1
- DT50:
- 142 d
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 7
- Temp.:
- 25 °C
- Hydrolysis rate constant:
- 0 h-1
- DT50:
- 143 d
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 7
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- 0 h-1
- DT50:
- 146 d
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 9
- Temp.:
- 20 °C
- Hydrolysis rate constant:
- 0 h-1
- DT50:
- 567 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 9
- Temp.:
- 25 °C
- Hydrolysis rate constant:
- 0 h-1
- DT50:
- 501 d
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 9
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- 0 h-1
- DT50:
- 287 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- hydrolytically stable based on preliminary test
- Validity criteria fulfilled:
- yes
- Conclusions:
- The main study were performed for the determination of the rate of hydrolysis of CJ309 at pH values normally found in the environment (pH4-9).
The half-life times of the test substance were:
pH4 pH7 pH9
Temperature t1/2 t1/2 t1/2
20 29.6 days 142 days 567 days
25 24.0 days 143 days 501 days
50 9.87 days 146 days 287 days - Executive summary:
The results of the physico-chemical properties of the test substance are given below.
Parameter Result Hydrolysis at pH4 t1/2=29.6 days at 20°C t1/2=24.2 days at 25°C t1/2=9.87 days at 50°C Hydrolysis at pH7 t1/2=142 days at 20°C t1/2=143 days at 25°C t1/2=146 days at 50°C Hydrolysis at pH9 t1/2=567 days at 20°C t1/2=501 days at 25°C t1/2=287 days at 50°C
Reference
1. Hydrolysis of the test substance at pH4
No test substance was detected in the blank buffer solutions.
The mean recoveries of the buffer solutions at t=0 fell within the criterion range of 90-110%. It demonstrated that the analytical method was adequate to support the hydrolysis study on the test substance.
Table 1. Main test – hydrolysis of the test substance at pH4 and 20°C
Sampling time (hrs) | Analysed concentration(mg/L) | Relativee concentration (%) | Logarithm relative concentration | Actual pH |
0 | 510 | 99.9 | 2.00 | 3.7 |
0 | 510 | 100 | 2.00 | 3.7 |
2 | 514 | 101 | 2.00 | 3.7 |
2 | 525 | 103 | 2.01 | 3.8 |
4 | 523 | 103 | 2.01 | 3.7 |
4 | 519 | 102 | 2.01 | 3.8 |
27 | 508 | 99.7 | 2.00 | 3.7 |
27 | 511 | 100 | 2.00 | 3.7 |
47 | 502 | 98.4 | 1.99 | 3.7 |
47 | 504 | 98.9 | 2.00 | 3.7 |
51 | 493 | 96.7 | 1.99 | 3.7 |
51 | 485 | 95.2 | 1.98 | 3.8 |
123 | 462 | 90.7 | 1.96 | 3.7 |
123 | 464 | 90.9 | 1.96 | 3.7 |
142 | 445 | 87.2 | 1.94 | 3.7 |
142 | 454 | 89.0 | 1.95 | 3.7 |
147 | 446 | 87.5 | 1.94 | 3.8 |
147 | 449 | 88.1 | 1.94 | 3.7 |
168 | 431 | 84.5 | 1.93 | 3.6 |
168 | 434 | 85.1 | 1.93 | 3.7 |
Table 2. Main test – hydrolysis of the test substance at pH4 and 50°C
Sampling time (hrs) | Analysed concentration(mg/L) | Relativee concentration (%) | Logarithm relative concentration | Actual pH |
0 | 527 | 99.9 | 2.00 | 3.7 |
0 | 528 | 100 | 2.00 | 3.7 |
2 | 531 | 101 | 2.00 | 3.7 |
2 | 523 | 99.2 | 2.00 | 3.7 |
4 | 531 | 101 | 2.00 | 3.6 |
4 | 514 | 97.4 | 1.99 | 3.7 |
27 | 490 | 92.8 | 1.97 | 3.7 |
27 | 485 | 92.0 | 1.96 | 3.7 |
47 | 469 | 88.9 | 1.95 | 3.6 |
47 | 459 | 87.0 | 1.94 | 3.7 |
51 | 445 | 84.3 | 1.93 | 3.7 |
51 | 441 | 83.6 | 1.92 | 3.7 |
123 | 374 | 70.9 | 1.85 | 3.6 |
123 | 367 | 69.5 | 1.84 | 3.7 |
142 | 350 | 66.4 | 1.82 | 3.6 |
142 | 346 | 65.5 | 1.82 | 3.7 |
147 | 348 | 65.9 | 1.82 | 3.7 |
147 | 346 | 65.5 | 1.82 | 3.7 |
168 | 323 | 61.2 | 1.79 | 3.7 |
168 | 318 | 60.3 | 1.78 | 3.7 |
Dye solutions in the concentration range 994-1028 mg/L were prepared from stock solutions. 0.426mL pH4 buffer, 0.5mL dye solutions and 0.074 mL 1N NaOH mixed to pH6.0-7.5 to terminate the hydrolysis reaction and avoid dye condensation.
Table 3. Recoveries
Temperature (°C) | Nominal concentration (mg/L) | Analysed concentration (mg/L) | Recovery (%) | Mean recovery (%) |
20 | 994 | 510 | 103 | 103 |
994 | 510 | 103 | ||
50 | 1028 | 527 | 103 | 104 |
1014 | 528 | 104 |
For testing of pseudo-first order kinetics the mean logarithms of the relative concentrations between 10% and 90% were plotted against time. At all temperatures linear relationships were obtained. The half-life times of the test substance were determined according to the model for pseudo-first order reactions.
All logarithms of the relative concentrations were correlated with time using linear regression analysis.
Table 4. Statistical parameters of the regression curves
Temperature (°C) | Slope (1/hours) | Intercept | Coefficient of correlation |
20 | -0.000424 | 2.01 | 0.947 |
50 | -0.00127 | 2.00 | 0.992 |
The rate constant (kobs) and half-life time of the test substance at each temperature was obtained and the Arrhenius equation was used to determine the rate constant and half-life time at 25°C).
Table 5. Rate constants (kobs) and half-life time (t1/2)
Temperature (°C) | kobs (1/hours) | t1/2 |
20 | 9.76 x 10^-4 | 29.6 days |
25 | 1.19 x 10^-3 | 24.2 days |
50 | 2.92 x 10^-3 | 9.87 days |
2. Hydrolysis of the test substance at pH7
No test substance was detected in the blank buffer solutions.
The mean recoveries of the buffer solutions at t=0 fell within the criterion range of 80-110%. It demonstrated that the analytical method was adequate to support the hydrolysis study on the test substance.
Table 6. Main test – hydrolysis of the test substance at pH7 and 20°C
Sampling time (hrs) | Analysed concentration(mg/L) | Relativee concentration (%) | Logarithm relative concentration | Actual pH |
0 | 503 | 99.7 | 2.00 | 7.1 |
0 | 505 | 100 | 2.00 | 7.1 |
2 | 493 | 97.8 | 1.99 | 7.1 |
2 | 494 | 98.0 | 1.99 | 7.1 |
5 | 494 | 98.0 | 1.99 | 7.1 |
5 | 494 | 98.1 | 1.99 | 7.0 |
17 | 469 | 93.1 | 1.97 | 7.1 |
17 | 464 | 92.1 | 1.96 | 7.1 |
66 | 529 | 105 | 2.02 | 7.1 |
66 | 524 | 104 | 2.02 | 7.1 |
71 | 502 | 99.6 | 2.00 | 7.0 |
71 | 502 | 99.6 | 2.00 | 7.1 |
165 | 502 | 99.6 | 2.00 | 7.1 |
165 | 508 | 101 | 2.00 | 7.1 |
168 | 505 | 100 | 2.00 | 7.1 |
168 | 511 | 101 | 2.01 | 7.1 |
Table 7. Main test – hydrolysis of the test substance at pH7 and 50°C
Sampling time (hrs) | Analysed concentration(mg/L) | Relativee concentration (%) | Logarithm relative concentration | Actual pH |
0 | 500 | 100 | 2.00 | 7.1 |
0 | 501 | 100 | 2.00 | 7.1 |
2 | 487 | 97.4 | 1.99 | 7.1 |
2 | 504 | 101 | 2.00 | 7.0 |
5 | 484 | 96.7 | 1.99 | 7.1 |
5 | 499 | 99.7 | 2.00 | 7.1 |
17 | 452 | 90.3 | 1.96 | 7.1 |
17 | 466 | 93.0 | 1.97 | 7.0 |
66 | 512 | 102 | 2.01 | 7.1 |
66 | 517 | 103 | 2.01 | 7.1 |
71 | 497 | 99.2 | 2.00 | 7.1 |
71 | 508 | 102 | 2.01 | 7.0 |
165 | 498 | 99.5 | 2.00 | 7.1 |
165 | 516 | 103 | 2.01 | 7.0 |
168 | 492 | 98.3 | 1.99 | 7.1 |
168 | 508 | 102 | 2.01 | 7.1 |
Dye solutions in the concentration range 1010-1048 mg/L were prepared from stock solutions. 0.5mL pH7 buffer and 0.5mL dye solutions mixed to pH6.0-7.5 to terminate the hydrolysis reaction and avoid dye condensation.
Table 8. Recoveries
Temperature (°C) | Nominal concentration (mg/L) | Analysed concentration (mg/L) | Recovery (%) | Mean recovery (%) |
20 | 1028 | 503 | 97.9 | 97.2 |
1048 | 505 | 96.4 | ||
50 | 1010 | 500 | 99.0 | 97.7 |
1040 | 501 | 96.3 |
For testing of pseudo-first order kinetics the mean logarithms of the relative concentrations between 10% and 90% were plotted against time. At all temperatures linear relationships were obtained. The half-life times of the test substance were determined according to the model for pseudo-first order reactions.
All logarithms of the relative concentrations were correlated with time using linear regression analysis.
Table 9. Statistical parameters of the regression curves
Temperature (°C) | Slope (1/hours) | Intercept | Coefficient of correlation |
20 | 8.84 x 10^-5 | 1.99 | 0.172 |
50 | 8.58 x 10^-5 | 1.99 | 0.138 |
The rate constant (kobs) and half-life time of the test substance at each temperature was obtained and the Arrhenius equation was used to determine the rate constant and half-life time at 25°C).
Table 10. Rate constants (kobs) and half-life time (t1/2)
Temperature (°C) | kobs (1/hours) | t1/2 |
20 | 2.04 x 10^-4 | 142 days |
25 | 2.02 x 10^-4 | 143 days |
50 | 1.98 x 10^-4 | 146 days |
3. Hydrolysis of the test substance at pH9
No test substance was detected in the blank buffer solutions.
The mean recoveries of the buffer solutions at t=0 fell within the criterion range of 90-110%. It demonstrated that the analytical method was adequate to support the hydrolysis study on the test substance.
Table 11. Main test – hydrolysis of the test substance at pH9 and 20°C
Sampling time (hrs) | Analysed concentration(mg/L) | Relativee concentration (%) | Logarithm relative concentration | Actual pH |
0 | 517 | 101 | 2.01 | 8.9 |
0 | 504 | 98.7 | 1.99 | 8.9 |
21 | 503 | 98.5 | 1.99 | 8.9 |
21 | 515 | 101 | 2.00 | 8.9 |
28 | 501 | 98.0 | 1.99 | 8.8 |
28 | 509 | 99.5 | 2.00 | 8.8 |
93 | 495 | 96.9 | 1.99 | 8.9 |
93 | 504 | 98.6 | 1.99 | 8.9 |
99 | 496 | 97.1 | 1.99 | 8.8 |
99 | 501 | 98.2 | 1.99 | 8.8 |
117 | 493 | 96.5 | 1.98 | 8.9 |
117 | 501 | 98.2 | 1.99 | 8.9 |
123 | 496 | 97.1 | 1.99 | 8.8 |
123 | 503 | 98.4 | 1.99 | 8.8 |
140 | 512 | 100 | 2.00 | 8.7 |
140 | 519 | 102 | 2.01 | 8.6 |
146 | 504 | 98.7 | 1.99 | 8.6 |
146 | 510 | 99.9 | 2.00 | 8.9 |
168 | 502 | 98.2 | 1.99 | 8.7 |
168 | 506 | 99.1 | 2.00 | 8.8 |
Table 12. Main test – hydrolysis of the test substance at pH9 and 50°C
Sampling time (hrs) | Analysed concentration(mg/L) | Relativee concentration (%) | Logarithm relative concentration | Actual pH |
0 | 500 | 101 | 2.00 | 8.8 |
0 | 490 | 99.1 | 2.00 | 8.8 |
21 | 519 | 105 | 2.02 | 8.8 |
21 | 506 | 102 | 2.01 | 8.8 |
28 | 501 | 101 | 2.01 | 8.7 |
28 | 510 | 103 | 2.01 | 8.7 |
93 | 495 | 100 | 2.00 | 8.8 |
93 | 501 | 101 | 2.01 | 8.8 |
99 | 489 | 98.9 | 2.00 | 8.7 |
99 | 499 | 101 | 2.00 | 8.7 |
117 | 487 | 98.5 | 1.99 | 8.8 |
117 | 496 | 100 | 2.00 | 8.8 |
123 | 489 | 98.7 | 1.99 | 8.7 |
123 | 495 | 100 | 2.00 | 8.7 |
140 | 501 | 101 | 2.01 | 8.6 |
140 | 516 | 104 | 2.02 | 8.6 |
146 | 492 | 99.3 | 2.00 | 8.7 |
146 | 499 | 101 | 2.00 | 8.7 |
168 | 489 | 98.7 | 1.99 | 8.7 |
168 | 493 | 99.7 | 2.00 | 8.8 |
Dye solutions in the concentration range 994-1028 mg/L were prepared from stock solutions. 0.426mL pH9 buffer, 0.5mL dye solutions and 0.074 mL 1N HCl mixed to pH6.0-7.5 to terminate the hydrolysis reaction and avoid dye condensation.
Table 13. Recoveries
Temperature (°C) | Nominal concentration (mg/L) | Analysed concentration (mg/L) | Recovery (%) | Mean recovery (%) |
20 | 1038 | 517 | 99.6 | 98.6 |
1034 | 504 | 97.5 | ||
50 | 1036 | 500 | 96.5 | 95.0 |
1048 | 490 | 93.5 |
For testing of pseudo-first order kinetics the mean logarithms of the relative concentrations between 10% and 90% were plotted against time. At all temperatures linear relationships were obtained. The half-life times of the test substance were determined according to the model for pseudo-first order reactions.
All logarithms of the relative concentrations were correlated with time using linear regression analysis.
Table 14. Statistical parameters of the regression curves
Temperature (°C) | Slope (1/hours) | Intercept | Coefficient of correlation |
20 | -0.0000221 | 2.00 | 0.0320 |
50 | -0.0000437 | 2.01 | 0.0873 |
The rate constant (kobs) and half-life time of the test substance at each temperature was obtained and the Arrhenius equation was used to determine the rate constant and half-life time at 25°C).
Table 15. Rate constants (kobs) and half-life time (t1/2)
Temperature (°C) | kobs (1/hours) | t1/2 |
20 | 5.09 x 10^-5 | 567 days |
25 | 5.77 x 10^-5 | 501 days |
50 | 1.01 x 10^-4 | 287 days |
Description of key information
The main study were performed for the determination of the rate of hydrolysis of CJ309 at pH values normally found in the environment (pH4-9). The half-life times of the test substance were:
pH4 pH7 pH9
Temperature t1/2 t1/2 t1/2
20 29.6 days 142 days 567 days
25 24.0 days 143 days 501 days
50 9.87 days 146 days 287 days
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 168 h
- at the temperature of:
- 20 °C
Additional information
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