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Diss Factsheets

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Deviations:
no
Remarks:
- The study was conducted according to the test guidelines in effect at the time of study conduct.
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Deviations:
no
Remarks:
- The study was conducted according to the test guidelines in effect at the time of study conduct.
GLP compliance:
yes
Radiolabelling:
no
Analytical monitoring:
no
Buffers:
- pH: pH 4, 7 and 9
- Type and final molarity of buffer:
pH 4: 0.2 M aqueous potassium dihydrogen orthophosphate (110 mL) was mixed with 0.07 M aqueous disodium hydrogen orthophosphate dodecahydrate (250 mL) and purified water (640 mL). The pH was adjusted to 4.0 ± 0.05 with orthophosphoric acid.

pH 7: 0.2 M aqueous potassium dihydrogen orthophosphate (250 mL) was mixed with 1 M sodium hydroxide (30 mL) and purified water (720 mL). The pH was adjusted to 7.0 ± 0.05 with 1 M hydrochloric acid.

pH 9: 0.1 M boric acid in 0.1 M aqueous potassium chloride (500 mL) was mixed with 1 M sodium hydroxide (21 mL) and purified water (480 mL). The pH was adjusted to 9.0 ± 0.05 with 1 M hydrochloric acid.
Details on test conditions:
TEST SYSTEM
- Type, material and volume of test flasks, other equipment used:
Aliquots (100 μL) of a stock solution of the test item in methanol (100 g/L) were added to separate Wheaton vials containing buffer solution (10 mL), which had been purged with nitrogen and preequilibrated at test temperature (50 ± 0.5°C). The samples, of nominal concentration 1 g/L, were placed in a 50°C waterbath in the dark until sampling was required (immediately, and then after 2.4 and 120 hours). At each sampling time, two samples were removed from the bath and an aliquot (1 mL) of each was diluted to volume (5 mL) with mobile phase for analysis by high performance liquid chromatography (HPLC).
Duration:
120 h
pH:
4
Initial conc. measured:
1 060 mg/L
Duration:
120 h
pH:
7
Initial conc. measured:
1 010 mg/L
Duration:
120 h
pH:
9
Initial conc. measured:
1 000 mg/L
Number of replicates:
1 vessel for each pH, two aliquots were taken for analysis at sampling time
Positive controls:
no
Negative controls:
no
Preliminary study:
The preliminary study showed that at each of pH 4, 7 and 9 and 50 ± 0.5ºC, less than 10% hydrolysis had occurred after 120 hours (5 days), equivalent to a half-life of greater than 1 year under environmental conditions (25°C). No further testing was considered necessary.
Transformation products:
no
% Recovery:
97.2
pH:
4
Temp.:
50 °C
Duration:
120 h
% Recovery:
112.6
pH:
7
Temp.:
50 °C
Duration:
120 h
% Recovery:
103
pH:
9
Temp.:
50 °C
Duration:
120 h
Key result
pH:
4
Temp.:
50 °C
DT50:
> 1 yr
Type:
not specified
Key result
pH:
7
Temp.:
50 °C
DT50:
> 1 yr
Type:
not specified
Key result
pH:
9
Temp.:
50 °C
DT50:
> 1 yr
Type:
not specified
Details on results:
TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes
Validity criteria fulfilled:
yes
Conclusions:
This study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
The test item was determined to be hydrolytically stable at pH 4, 7, and 9.
Executive summary:

A study was performed to determine the rate of hydrolysis of the test item as a function of pH. The method followed is amongst those described in Commission Regulation (EC) No. 440/2008 (Method C.7) and the OECD Guidelines for the Testing of Chemicals (Method 111). The test item was exposed to pH 4, 7 and 9 buffers at 50°C for 120 hours. Results showed that the half-life would be greater than a year at 25°C. The test item was determined to be hydrolytically stable under acidic, neutral and basic conditions.

Description of key information

The test substance is hydrolytically stable under environmental conditions with a half-life of >1 year at 25°C at pH 4, 7, and 9.

Key value for chemical safety assessment

Half-life for hydrolysis:
1 yr
at the temperature of:
50 °C

Additional information