Registration Dossier
Registration Dossier
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EC number: 820-015-3 | CAS number: 129874-15-3
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20170603-20171208
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- GLP compliance:
- no
- Remarks:
- conducted at the company internal.
- Analytical monitoring:
- yes
- Remarks:
- Spectrometer SHIMADZU/UV-2700 Reference solvent Water Cell (path length/material) 1 cm / Quartz Operating temperature 20 ± 2 ˚C Wavelength range 800 ~ 200 nm Wavelength accuracy ± 0.5 nm
- Buffers:
- - Acetate buffer pH 4, 0.1 M: solution of 0.1 M acetic acid adjusted to pH 4 using 10 N sodium hydroxide. The buffer contains 0.002% (w/v) PREVENTAL BIT 20.
- Phosphate buffer pH 7, 0.1 M: solution of 0.1 M potassium dihydrogenphosphate adjusted to pH 7 using 10 N sodium hydroxide. The buffer contains 0.002% (w/v) PREVENTAL BIT 20.
- Borate buffer pH 9, 0.1 M: solution of 0.1 M boric acid and 0.1 M potassium chloride adjusted to pH 9 using 10 N sodium hydroxide. The buffer contains 0.002% (w/v) PREVENTAL BIT 20. - Duration:
- 168 h
- pH:
- 4
- Temp.:
- 20 °C
- Initial conc. measured:
- ca. 65 mg/L
- Remarks:
- UV test
- Duration:
- 168 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 60 mg/L
- Remarks:
- UV test
- Duration:
- 168 h
- pH:
- 7
- Temp.:
- 20 °C
- Initial conc. measured:
- ca. 75 mg/L
- Remarks:
- UV test
- Duration:
- 168 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 67 mg/L
- Remarks:
- UV test
- Duration:
- 168 h
- pH:
- 9
- Temp.:
- 20 °C
- Initial conc. measured:
- ca. 86 mg/L
- Remarks:
- UV test
- Duration:
- 168 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 87 mg/L
- Remarks:
- UV test
- Number of replicates:
- two
- Positive controls:
- no
- Negative controls:
- no
- Transformation products:
- no
- % Recovery:
- ca. 96
- pH:
- 4
- Temp.:
- 20 °C
- Duration:
- 168 h
- Remarks on result:
- other: UV test
- % Recovery:
- ca. 117
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 168 h
- Remarks on result:
- other: UV test
- % Recovery:
- ca. 105
- pH:
- 7
- Temp.:
- 20 °C
- Duration:
- 168 h
- Remarks on result:
- other: UV test
- % Recovery:
- ca. 104
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 168 h
- Remarks on result:
- other: UV test
- % Recovery:
- ca. 96
- pH:
- 9
- Temp.:
- 20 °C
- Duration:
- 168 h
- Remarks on result:
- other: UV test
- % Recovery:
- 93
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 168 h
- Remarks on result:
- other: UV test
- pH:
- 4
- Temp.:
- 20 °C
- Hydrolysis rate constant:
- 0 h-1
- DT50:
- 896 d
- Remarks on result:
- other: UV test
- pH:
- 4
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- 0 h-1
- DT50:
- 841 d
- Remarks on result:
- other: UV test
- pH:
- 7
- Temp.:
- 20 °C
- Hydrolysis rate constant:
- 0 h-1
- DT50:
- 606 d
- Remarks on result:
- other: UV test
- pH:
- 7
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- 0 h-1
- DT50:
- 446 d
- Remarks on result:
- other: UV test
- pH:
- 9
- Temp.:
- 20 °C
- Hydrolysis rate constant:
- 0 h-1
- DT50:
- 912 d
- Remarks on result:
- other: UV test
- pH:
- 9
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- 0.001 h-1
- DT50:
- 34 d
- Remarks on result:
- other: UV test
- Validity criteria fulfilled:
- yes
- Conclusions:
- According to OECD 111 and EC C.7 test method, the half-life time of Everdirect SH12 at 20°C are 896 days, 606 days and 91.5 days respectively at pH=4, pH=7 and pH=9.
- Executive summary:
This test using the procedures outlined in the Everlight Study Plan for 170302-09, OECD 111 (OECD, 2004) and EC C.7 (EC no. 440/2008).
In Main study, the mean recoveries of the buffer solutions at pH=4 and t=0 fell within the criterion range of 80 -120%. It demonstrated that the analytical method was adequate to support the hydrolysis study on the test substance. At pH=7, the mean recoveries of the buffer solutions at t=0 fell within the criterion range of 80-110%. At pH=9, the mean recovery of the buffer solutions at t=0 fell within the criterion range of 4.7 -110%. 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. 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 20°C.
According to OECD 111 and EC C.7 test method, the half-life time of Everdirect SH12 at 20°C are 896 days, 606 days and 91.5 days respectively at pH=4, pH=7 and pH=9.
Reference
Description of key information
According to OECD 111 and EC C.7 test method, the half-life time of Everdirect SH12 at 20°C are 896 days, 606 days and 91.5 days respectively at pH=4, pH=7 and pH=9.
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 896 d
- at the temperature of:
- 20 °C
Additional information
This test using the procedures outlined in the Everlight Study Plan for 170302-09, OECD 111 (OECD, 2004) and EC C.7 (EC no. 440/2008).
In Main study, the mean recoveries of the buffer solutions at pH=4 and t=0 fell within the criterion range of 80 -120%. It demonstrated that the analytical method was adequate to support the hydrolysis study on the test substance. At pH=7, the mean recoveries of the buffer solutions at t=0 fell within the criterion range of 80-110%. At pH=9, the mean recovery of the buffer solutions at t=0 fell within the criterion range of 4.7 -110%. 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. 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 20°C.
According to OECD 111 and EC C.7 test method, the half-life time of Everdirect SH12 at 20°C are 896 days, 606 days and 91.5 days respectively at pH=4, pH=7 and pH=9.
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