Registration Dossier
Registration Dossier
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EC number: 264-761-2 | CAS number: 64265-45-8
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-03-19 to 2007-06-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Version / remarks:
- adopted December 29, 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products: 0 hrs, 2.4 hrs and 5 days
- Sampling intervals/times for pH measurements: 0 hrs, 2.4 hrs and 5 days - Buffers:
- - pH: 4
- Composition of buffer: 16.6% 0.05 M sodium acetate and 83.4% 0.05 M acetic acid
- pH: 7
- Composition of buffer: solution of 0.05 M potassium dihydrogenphosphate adjusted to pH 7 using 1 N sodium hydroxide
- pH: 9
- Composition of buffer: solution of 0.05 M boric acid and 0.05 M potassium chloride adjusted to pH 9 using 1 N sodium hydroxide - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: sealed glass vessels
- Sterilisation method: filter-sterilisation (0.2 µm)
- Lighting: no data
- Measures to exclude oxygen: nitrogen gas was purged through the solutions for 5 minutes
- If no traps were used, is the test system closed/open: closed - Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 1 095 mg/L
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 1 181 mg/L
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 1 054 mg/L
- Number of replicates:
- 1
- Positive controls:
- no
- Negative controls:
- no
- Preliminary study:
- In a preliminary test the decrease in concentration of the test substance was measured at pH 4.0, 7.0 and 9.0. Since the decrease in concentration was below 10% after 5 days, no further testing is necessary.
- Transformation products:
- no
- % Recovery:
- 103
- pH:
- 4
- Temp.:
- 25 °C
- Duration:
- 2.4 h
- % Recovery:
- 96.5
- pH:
- 4
- Temp.:
- 25 °C
- Duration:
- 5 d
- % Recovery:
- 101
- pH:
- 7.1
- Temp.:
- 25 °C
- Duration:
- 2.4 h
- % Recovery:
- 96.1
- pH:
- 7.1
- Temp.:
- 25 °C
- Duration:
- 5 d
- % Recovery:
- 104
- pH:
- 8.9
- Temp.:
- 25 °C
- Duration:
- 2.4 h
- % Recovery:
- 98.1
- pH:
- 8.9
- Temp.:
- 25 °C
- Duration:
- 5 d
- Key result
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Type:
- not specified
- Key result
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Type:
- not specified
- Key result
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Type:
- not specified
- Validity criteria fulfilled:
- yes
- Conclusions:
- The half-life of Amphopropionate C8 at 25°C, pH 4, 7 and 9 is >1 year.
- Executive summary:
The hydrolysis of Amphopropionate C8 at 1000 mg a.i./L was studied at 50ºC in sterile aqueous buffered solutions at pH 4 (acetate buffer), pH 7 (phosphate buffer) and pH 9 (borate buffer) for 5 days. The experiment was conducted in accordance with EU method C.7 (1992). Samples were analysed by HPLC at 0 h, 2.4 h and 5 d. In a preliminary test the decrease in concentration of the test substance was measured at pH 4.0, 7.0 and 9.0. Since the decrease in concentration was below 10% after 5 days, no further testing was necessary.
The half-life of Amphopropionate C8 at 25°C, pH 4, 7 and 9 is >1 year.
Reference
Description of key information
half-life 25°C, pH 4, 7 and 9 >1 year (EU method C.7; RL1; GLP)
Key value for chemical safety assessment
Additional information
The hydrolysis of Amphopropionate C8 at 1000 mg a.i./L was studied at 50ºC in sterile aqueous buffered solutions at pH 4 (acetate buffer), pH 7 (phosphate buffer) and pH 9 (borate buffer) for 5 days. The experiment was conducted in accordance with EU method C.7 (1992). Samples were analysed by HPLC at 0 h, 2.4 h and 5 d. In a preliminary test the decrease in concentration of the test substance was measured at pH 4.0, 7.0 and 9.0. Since the decrease in concentration was below 10% after 5 days, no further testing was necessary.
The half-life of Amphopropionate C8 at 25°C, pH 4, 7 and 9 is >1 year.
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