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Environmental fate & pathways

Hydrolysis

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Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 September 2006 - 6 October 2006
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)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Radiolabelling:
no
Analytical monitoring:
yes
Details on sampling:
- Sampling intervals for the parent/transformation products: 0, 2.4, 24, 120 h
Buffers:
- pH: 4
- Composition of buffer: Potassium hydrogen phthalate (0.05 M)

- pH: 7
- Composition of buffer: Disodium hydrogen orthophosphate (anhydrous) (0.03 M), Potassium dihydrogen orthophosphate (0.02 M) and Sodium chloride (0.02 M)

- pH: 9
- Composition of buffer: Disodium tetraborate (0.01 M) and Sodium chloride (0.02 M)
Details on test conditions:
TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: stoppered glass flasks
- Sterilisation method: filtration through a 0.2 μm membrane filter
- Lighting: The solutions were shielded from light whilst maintained at the test temperature.
- Measures taken to avoid photolytic effects: The solutions were shielded from light whilst maintained at the test temperature.
- Measures to exclude oxygen: ultrasonication and degassing with nitrogen
- If no traps were used, is the test system closed/open : closed
- Is there any indication of the test material adsorbing to the walls of the test apparatus? No

Duration:
120 h
pH:
4
Temp.:
50 °C
Initial conc. measured:
1 g/L
Duration:
120 h
pH:
7
Temp.:
50 °C
Initial conc. measured:
1 g/L
Duration:
120 h
pH:
9
Temp.:
50 °C
Initial conc. measured:
1 g/L
Number of replicates:
2
Positive controls:
no
Negative controls:
no
Test performance:
The linearity of the detector response with respect to concentration was assessed for all three sample pH matrices over the nominal concentration range of 0 to 400 mg/l. These were satisfactory with a correlation coefficient of 1.000 being obtained in each case.
Transformation products:
not measured
Details on hydrolysis and appearance of transformation product(s):
Not measured.
% Recovery:
100
pH:
4
Temp.:
50 °C
Duration:
120 h
% Recovery:
100
pH:
7
Temp.:
50 °C
Duration:
120 h
% Recovery:
95
pH:
9
Temp.:
50 °C
Duration:
120 h
Key result
pH:
4
Temp.:
25 °C
DT50:
> 1 yr
Key result
pH:
7
Temp.:
25 °C
DT50:
> 1 yr
Key result
pH:
9
Temp.:
25 °C
DT50:
> 1 yr
Details on results:
TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes
Validity criteria fulfilled:
yes
Conclusions:
Based on a degradation study performed ccording to EC guidance and GLP principles, the estimated half-life at 25°C of the test substance is >1 year at pH 4, 7 and 9.

Description of key information

Based on a degradation study performed ccording to EC guidance and GLP principles, the estimated half-life at 25°C of the test substance is >1 year at pH 4, 7 and 9.

Key value for chemical safety assessment

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

Additional information

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