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EC number: 816-324-8 | CAS number: 2044770-20-7
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019
- 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)
- GLP compliance:
- yes (incl. QA statement)
- Radiolabelling:
- no
- Buffers:
- Buffer solution pH 4 0.18 g of sodium hydroxide and 5.7555 g of mono potassium citrate were dissolved in 500 mL purified water.
Buffer solution pH 7 3.854 g of ammonium acetate were dissolved in 500 mL purified water.
Buffer solution pH 9 0.426 g sodium hydroxide, 1.8638 g potassium chloride and 1.5458 g boric acid were dissolved in 500 mL purified water. - Details on test conditions:
- Replicates Duplicates per pH and sampling date, single injections
Test container (sterile) Headspace vials, volume: 21 mL
Test volume 5 mL
Test concentration / solution 100 mg/L (pH 4, 7 and 9)
Co-solvents Purified water, 1% (v/v)
Application The test solution was prepared at test start via stock solution. Sterile buffer solutions were spiked with the stock solution and sterilized by filtration through 0.20 µm sterile membrane filters (In this case adsorption of the test item on the filter was checked during method validation). Afterwards the test solution was given into the test containers and transferred into the thermostat. The time between test item application and transfer to thermostat / analysis did not exceed 30 min.
Incubation time 120 h
Temperature 50 ± 0.5 °C
Light Photolytic effects were avoided by using an opaque water bath. - Duration:
- 0 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 101 mg/L
- Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 96.3 mg/L
- Duration:
- 0 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 98.8 mg/L
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 97.7 mg/L
- Duration:
- 0 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 95.2 mg/L
- Duration:
- 120 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 94.9 mg/L
- Number of replicates:
- Duplicates per pH and sampling date, single injections
- Positive controls:
- no
- Remarks:
- According to the guidelines no reference item is necessary.
- Negative controls:
- no
- Transformation products:
- no
- % Recovery:
- 95
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 120 h
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- 99
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 120 h
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- 100
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 120 h
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 4
- Temp.:
- 50 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 7
- Temp.:
- 50 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 9
- Temp.:
- 50 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
- Validity criteria fulfilled:
- yes
- Conclusions:
- The test item PU-2017-766 was found to be hydrolytically stable at all pH conditions.
- Executive summary:
Hydrolysis as a function of pH was determined according to OECD Guideline No. 111 and Council Regulation (EC) No. 440/2008, Method C.7 for the test itemPU-2017-766(batch number: UR18201873) from 2019-05-23 to 2019-05-28 at Noack Laboratorien, 31157 Sarstedt, Germany.
Analyses of the test item PU-2017-766were performed via LC‑MS/MS on a reversed phase analytical column using the test item as external standard. The analytical method was validated with satisfactory results with regard to linearity, accuracy, precision and specificity.
The study was conducted with test item concentration of 100 mg/L in buffer solutions at pH 4, 7 and 9 at a test temperature of 50 °C (preliminary test). Samples were taken at test start (0 hours) and test end (120 hours). Pure test systems (buffer solution pH 4, 7 and 9) were analysed at test start and test end and there was no analytical interference with the test item.
No significant elimination was observed and therefore the test item was considered as hydrolytically stable under this condition and a half-life of > 1 year could be assumed for environmental typical temperatures.
Reference
Description of key information
The test item PU-2017-766 was found to be hydrolytically stable at all pH conditions.
Key value for chemical safety assessment
Additional information
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