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Environmental fate & pathways

Hydrolysis

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 October 2007 to 23 January 2008
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)
GLP compliance:
yes (incl. QA statement)
Radiolabelling:
no
Analytical monitoring:
yes
Details on sampling:
sampling at t= 0, t=2.4 hours and t=5 days. Samples at 2.4 hours and 5 days were cooled with running tap water. All samples were diluted 100 times with 45/55 (v/v) methanol/milli-Q water and analyzed.
Buffers:
- pH: 4
- Composition of buffer: solution of 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: glass flasks
- Sterilisation method: 0.5 um filter
- Lighting: no data
- Measures taken to avoid photolytic effects: none
- Measures to exclude oxygen: nitrogen gas was purged through the flasks during 5 minutes
- No traps were used; the test system was closed
- Is there any indication of the test material adsorbing to the walls of the test apparatus: no
TEST MEDIUM
- Preparation of test solutions: 0.01 M in buffer solutions
Duration:
5 d
pH:
4
Temp.:
50 °C
Initial conc. measured:
>= 1 373 - <= 1 386 mg/L
Duration:
5 d
pH:
7
Temp.:
50 °C
Initial conc. measured:
>= 1 392 - <= 1 396 mg/L
Duration:
5 d
pH:
9
Temp.:
50 °C
Initial conc. measured:
>= 1 339 - <= 1 371 mg/L
Number of replicates:
single per pH
Positive controls:
no
Negative controls:
no
Statistical methods:
NA
Preliminary study:
only a preliminary study was performed
Transformation products:
not measured
% Recovery:
>= 99.5 - < 100
pH:
4
Temp.:
50 °C
Duration:
>= 2.4 - <= 120 h
Remarks on result:
hydrolytically stable based on preliminary test
% Recovery:
>= 99.7 - <= 100
pH:
7.1
Temp.:
50 °C
Duration:
>= 2.4 - <= 120 h
Remarks on result:
hydrolytically stable based on preliminary test
% Recovery:
>= 99.8 - <= 102
pH:
9
Temp.:
50 °C
Duration:
>= 2.4 - <= 120 h
Remarks on result:
hydrolytically stable based on preliminary test
pH:
4
Temp.:
50 °C
DT50:
> 1 yr
Type:
not specified
Remarks on result:
hydrolytically stable based on preliminary test
pH:
7.1
Temp.:
50 °C
DT50:
> 1 yr
Type:
not specified
Remarks on result:
hydrolytically stable based on preliminary test
pH:
9
Temp.:
50 °C
DT50:
> 1 yr
Type:
not specified
Remarks on result:
hydrolytically stable based on preliminary test
Details on results:
half life at 25 °C
pH 4 > 1 year
pH 7 > 1 year
pH 9 > 1 year
Conclusions:
The substance is hydrolytically stable at pH 4, 7 and 9
Executive summary:

In a hydrolysis study (preliminary test at pH, 4,7 and 9) the substance was stable over 5 days at 50 °C. The substance is considered to be hydrolytically stable at 25 °C at all pHs (t1/2 >1 year).

Description of key information

In a hydrolysis study (preliminary test at pH, 4,7 and 9) the substance was stable over 5 days at 50 °C. The substance is considered to be hydrolytically stable at 25 °C at all pHs (t1/2 >1 year).

Key value for chemical safety assessment

Half-life for hydrolysis:
1 yr
at the temperature of:
25 °C

Additional information