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Hydrolysis

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Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 March 1994 to 06 June 1994
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:
Commission Directive 92/69/EEC
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
no
Buffers:
pH 4 BUFFER
Citric acid 0.05 mol dm-3
Sodium hydroxide 0.10 mol dm-3
Hydrochloric acid 0.05 mol dm-3

pH 7 BUFFER
Disodium hydrogen orthophosphate 0.04127 mol dm-3
Potassium dihydrogen orthophosphate 0.0282 mol dm-3

pH9 BUFFER
Disodium tetraborate 0.05 mol dm-3
Hydrochloric acid 0.0192 mol dm-3
Duration:
5 d
pH:
4
Temp.:
50 °C
Initial conc. measured:
3.01 g/L
Duration:
5 d
pH:
7
Temp.:
50 °C
Initial conc. measured:
3.03 g/L
Duration:
5 d
pH:
9
Temp.:
50 °C
Initial conc. measured:
2.98 g/L
Transformation products:
no
% Recovery:
99.5
pH:
4
Temp.:
50 °C
Duration:
2.4 h
Remarks on result:
other: equivalent to 2.99 g/L
% Recovery:
104
pH:
4
Temp.:
50 °C
Duration:
24 h
Remarks on result:
other: equivalent to 3.14 g/L
% Recovery:
98.8
pH:
4
Temp.:
50 °C
Duration:
48 h
Remarks on result:
other: equivalent to 2.97 g/L
% Recovery:
98.2
pH:
4
Temp.:
50 °C
Duration:
120 h
Remarks on result:
other: equivalent to 2.96 g/L
% Recovery:
104
pH:
7
Temp.:
50 °C
Duration:
2.4 h
Remarks on result:
other: equivalent to 3.13 g/L
% Recovery:
104
pH:
7
Temp.:
50 °C
Duration:
24 h
Remarks on result:
other: equivalent to 3.15 g/L
% Recovery:
102
pH:
7
Temp.:
50 °C
Duration:
48 h
Remarks on result:
other: equivalent to 3.09 g/L
% Recovery:
97.4
pH:
7
Temp.:
50 °C
Duration:
120 h
Remarks on result:
other: equivalent to 2.95 g/L
% Recovery:
104
pH:
9
Temp.:
50 °C
Duration:
2.4 h
Remarks on result:
other: equivalent to 3.09 g/L
% Recovery:
101
pH:
9
Temp.:
50 °C
Duration:
24 h
Remarks on result:
other: equivalent to 3.00 g/L
% Recovery:
100
pH:
9
Temp.:
50 °C
Duration:
48 h
Remarks on result:
other: equivalent to 2.99 g/L
% Recovery:
96.2
pH:
9
Temp.:
50 °C
Duration:
120 h
Remarks on result:
other: equivalent to 2.87 g/L
pH:
4
Remarks on result:
not measured/tested
pH:
7
Remarks on result:
not measured/tested
pH:
9
Remarks on result:
not measured/tested
Details on results:
- Peak heights of the pair of standards associated with each sample were corrected to nominal concentration and the mean value was taken prior to calculation of the sample concentration.
- Typical chromatograms are attached.
- Peak heights relating to the standard and sample solutions are attached.
Validity criteria fulfilled:
not applicable
Conclusions:
The test material was found to undergo less than 10 % hydrolysis after 5 days at 50 °C in pH 4, pH 7 and pH 9 buffers.
Executive summary:

Hydrolysis as a function of pH was investigated using EU Method C.7. The test material was found to undergo less than 10 % hydrolysis after 5 days at 50 °C in pH 4, pH 7 and pH 9 buffers.

Description of key information

The test material was found to undergo less than 10 % hydrolysis after 5 days at 50°C in pH 4, pH 7 and pH 9 buffers (EU Method C.7).

Key value for chemical safety assessment

Additional information

Hydrolysis as a function of pH was investigated using EU Method C.7. The test material was found to undergo less than 10 % hydrolysis after 5 days at 50°C in pH 4, pH 7 and pH 9 buffers.