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EC number: 305-729-0 | CAS number: 95009-01-1
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20170801-20171124
- 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:
- Digital Electronic Indictors + S.S.R. with PID automatic calculation capability
- 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. 70 mg/L
- Remarks:
- HPLC test
- Duration:
- 168 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 70 mg/L
- Remarks:
- HPLC test
- Duration:
- 168 h
- pH:
- 7
- Temp.:
- 20 °C
- Initial conc. measured:
- ca. 50 mg/L
- Remarks:
- UV test
- Duration:
- 168 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 65 mg/L
- Remarks:
- UV test
- Duration:
- 168 h
- pH:
- 9
- Temp.:
- 20 °C
- Initial conc. measured:
- ca. 55 mg/L
- Remarks:
- HPLC test
- Duration:
- 168 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 60 mg/L
- Remarks:
- HPLC test
- Number of replicates:
- two
- Positive controls:
- yes
- Negative controls:
- yes
- Statistical methods:
- System control, data acquisition and data processing were performed using the following programme: Empower version 5.00 (Waters, Milford, MA, USA)
- Transformation products:
- no
- % Recovery:
- ca. 121
- pH:
- 4
- Temp.:
- 20 °C
- Duration:
- 168 h
- Remarks on result:
- other: HPLC test
- % Recovery:
- ca. 123
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 168 h
- Remarks on result:
- other: HPLC test
- % Recovery:
- ca. 97.3
- pH:
- 7
- Temp.:
- 20 °C
- Duration:
- 168 h
- Remarks on result:
- other: UVA test
- % Recovery:
- ca. 102
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 168 h
- Remarks on result:
- other: UVA test
- % Recovery:
- ca. 113
- pH:
- 9
- Temp.:
- 20 °C
- Duration:
- 168 h
- Remarks on result:
- other: HPLC test
- % Recovery:
- 103
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 168 h
- Remarks on result:
- other: HPLC test
- pH:
- 4
- Temp.:
- 20 °C
- Hydrolysis rate constant:
- -0 h-1
- DT50:
- 443 d
- Remarks on result:
- other: HPLC test
- pH:
- 4
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- -0 h-1
- DT50:
- 361 d
- Remarks on result:
- other: HPLC test
- pH:
- 7
- Temp.:
- 20 °C
- Hydrolysis rate constant:
- -0 h-1
- DT50:
- 117 d
- Remarks on result:
- other: UVA test
- pH:
- 7
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- -0 h-1
- DT50:
- 65 d
- Remarks on result:
- other: UV test
- pH:
- 9
- Temp.:
- 20 °C
- Hydrolysis rate constant:
- -0 h-1
- DT50:
- 37.7 d
- Remarks on result:
- other: HPLC test
- pH:
- 9
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- -0.001 h-1
- DT50:
- 10 d
- Remarks on result:
- other: HPLC test
- Validity criteria fulfilled:
- yes
- Conclusions:
- According to OECD 111 and EC C.7 test method, the half-life time of Everlan SL65 at 20°C are 443 days, 117 days and 37.7 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 Everlan SL65 at 20°C are 443 days, 117 days and 37.7 days respectively at pH=4, pH=7 and pH=9.
Reference
The result of pH 7 from HPLC is not reasonable due to the significant tailing effect. So recheck with UV test (SHIMADZU UV-2700,λ=429nm).
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.
Description of key information
According to OECD 111 and EC C.7 test method, the half-life time of Everlan SL65 at 20°C are 443 days, 117 days and 37.7 days respectively at pH=4, pH=7 and pH=9.
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 117 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 Everlan SL65 at 20°C are 443 days, 117 days and 37.7 days respectively at pH=4, pH=7 and pH=9.
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