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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:
20.07.-27.07.2015
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)
Analytical monitoring:
yes
Buffers:
The hydrolysis of test substance was examined at buffered solutions of selected pH value: 4.0, 7.0 and 9.0. The actual pH value at given temperature was measured using a calibrated pH meter. All prepared buffer solutions were sterilized in an autoclave (121 °C, 50 min) and purged by nitrogen. -Buffer pH 4.0-pH 4.04, (26.9°C)-Buffer pH 7.0-pH 7.02 (26.9°C)-Buffer pH 9.0-pH 9.02 (26.9°C)
Details on test conditions:
TEST SYSTEM- Type, material and volume of test flasks, other equipment used: volumetric flask wrapped with an aluminum foil and tightly closed with a stopper. - Sterilisation method: All glassware, reagent-grade water and buffer solutions were sterilized in an autoclave (121 °C, 50 min). TEST MEDIUM- Kind and purity of water: deonized waterCALIBRATION SOLUTIONSStock Solution (SS, 10 000 mg/L): Approximately 100 mg of Akardit was weighed into a 10 mL volumetric flask, dissolved in and diluted to volume with ACN g.g. SAMPLE SOLUTIONS407 μL of (10 000 μg/mL) stock solution was pipetted into a 50mL volumetric flask and diluted with a buffered solution of certain pH (4.0, 7.0, or 9.0) – in duplicate. A nominal concentration of 80 mg/L akardit was prepared.
Duration:
6.83 d
pH:
4.01
Temp.:
50 °C
Duration:
6.83 d
pH:
6.98
Temp.:
50 °C
Duration:
6.83 d
pH:
8.94
Temp.:
50 °C
Number of replicates:
2 replicate
Positive controls:
no
Negative controls:
no
Preliminary study:
The preliminary test has shown that the test substance was not hydrolyzed by more than 10% in period of 5 days at pH 4, 7 and 9
Transformation products:
no
% Recovery:
0.4
pH:
4.01
Temp.:
50 °C
Duration:
6.83 d
% Recovery:
-0.2
pH:
6.98
Temp.:
50 °C
Duration:
6.83 d
% Recovery:
0.4
pH:
8.94
Temp.:
50 °C
Duration:
6.83 d
Key result
pH:
4.01
Temp.:
50 °C
Remarks on result:
hydrolytically stable based on preliminary test
Key result
pH:
6.98
Temp.:
50 °C
Remarks on result:
hydrolytically stable based on preliminary test
Key result
pH:
8.94
Temp.:
50 °C
Remarks on result:
hydrolytically stable based on preliminary test
Validity criteria fulfilled:
yes
Conclusions:
The preliminary test has shown that the test substance was not hydrolyzed by more than 10% in period of 5 days at pH 4, 7 and 9. Therefore the test substance was considered to be hydrolytically stable at above pHs. It can be assumed that the half-time at 25 °C would be > 1 year.
Executive summary:

The procedure was performed according to: Method C.7 – Degradation – Abiotic Degradation: Hydrolysis as a Function of pH, Council regulation (EC) No 440/2008. Published in OJ No L 142/518 May 2008 and OECD Test Guidline No.111, Hydrolysis as a function of pH, Adopted April 13, 2004.

 

The preliminary test has shown that the test substance was not hydrolyzed by more than 10% in period of 5 days at pH 4, 7 and 9. Therefore the test substance was considered to be hydrolytically stable at above pHs. It can be assumed that the half-time at 25 °C would be> 1 year.

Description of key information

The test was performed according to method C.7 – Degradation – Abiotic Degradation: Hydrolysis as a Function of pH, Council regulation (EC) No 440/2008. Published in OJ No L 142/518 May 2008.

Only one study is available.

GLP study.

Klimish score 1.

The preliminary test has shown that the test substance was not hydrolyzed by more than 10% in period of 5 days at pH 4, 7 and 9. Therefore the test substance was considered to be hydrolytically stable at above pHs. It can be assumed that the half-time at 25 °C would be> 1 year.

Key value for chemical safety assessment

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

Additional information