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EC number: 414-810-0 | CAS number: - A-88820.605
Hydrolysis
Administrative data
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6th February and 1st March 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study carried out in accordance with method C7 of commission directive 92/69/EEC and in accordance with GLP. The test material was well characterised
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- GLP compliance:
- yes
Test material
- Reference substance name:
- A mixture of: bis(1S,2S,4S)-(1-benzyl-4-tert-butoxycarboxamido-2-hydroxy-5-phenyl)pentylammonium succinate; isopropyl alcohol
- EC Number:
- 414-810-0
- EC Name:
- A mixture of: bis(1S,2S,4S)-(1-benzyl-4-tert-butoxycarboxamido-2-hydroxy-5-phenyl)pentylammonium succinate; isopropyl alcohol
- Cas Number:
- 144163-85-9
- Molecular formula:
- Empirical formula: C25H35N2O5
- IUPAC Name:
- butanedioic acid; propan-2-ol; bis(tert-butyl N-[(4R)-5-amino-4-hydroxy-1,6-diphenylhexan-2-yl]carbamate)
Constituent 1
Study design
- Analytical monitoring:
- yes
- Details on sampling:
- Samples were taken at 0 hours, 2.4 hours and 5days. a aliquot of test solutin was taken and diluted prior to analysis by HPLC
- Buffers:
- pH 4 buffer:
potassium dihydrogen citrate (4.6 g) was dissolved in distilled water. PH adjusted to 4 with 1M sodium hydroxide solution as the temperature of the solution reached 50 oC +/- 0.5 oC
pH 7.00 buffer
potassium dihydrogen orthophosphate (2.77 g0 was dissolved in distilled water (1 litre). pH was adjusted to 4.0 with 1M sodium hydroxide solution.
pH 9 buffer
Potassium chloride (1.5g) and boric acid (1.25 g) were dissolved in distilled water (1 litre). the pH was adjusted to 9.00 with 1 M sodium hydroxide solution - Details on test conditions:
- performed at 50 C and pH 4, 7.00 and 9
nine 100 ml volumetric flasks were pre-calibrated at 50 oC with distilled water (100 ml at 20 oC) in a water bath at 50 oC. the flasks were then marked at the new level.
Prior to the test, these flasks were rinsed with ethanol and alowed to drip dry. The buffer solutions were autoclaved at 121 oC for 15 minutes and then purged with nitrogen for 15 minuts prior to use.
Duration of testopen allclose all
- Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 0.25 µg/L
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 0.25 µg/L
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 0.25 µg/L
- Number of replicates:
- three
- Positive controls:
- yes
- Remarks:
- spiking solution - test substance was weighedinto a 20 ml volumetric flask and made to volume with methanol to give a final concentration of 52854 ug/ml
- Negative controls:
- yes
- Remarks:
- buffer solution
Results and discussion
- Preliminary study:
- at 50 C showed less than 10% was hydrolysed after 2.4 hrs and 5 days at all pH measurements
- Test performance:
- No signifance difference between initial and those made at 2.4 hrs. Negative value observed are within the measurement error.
- Transformation products:
- not specified
Total recovery of test substance (in %)
- % Recovery:
- ca. 101.3
- pH:
- 4
- Temp.:
- 50 °C
Dissipation DT50 of parent compoundopen allclose all
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- 1 d
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- ca. 1 d
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- ca. 1 yr
- Details on results:
- 50 % hydrolysis occuring in 2.4 hours at 50 oC is equivalent to a half-life of 1 day at 25 oC
10% hydrolysis occurring in 5 days at 50 oC is equivalent to a half life of 1 year at 25 oC
applying these criteria to the results obtaind the half life at 25 oC can be estimated to be beween one day and one year at pH 4 and 7, and greater thanor equal to one year at pH 9.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- A-88820.605 has been found to undergo significant hydrolysis at 50 oC for pH 4 and 7 and 10 % hydrolysis at pH 9.
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