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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:
From 11 October 2016 to 25 October 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Version / remarks:
April 2014
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Version / remarks:
May 2008
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 835.2120 (Hydrolysis of Parent and Degradates as a Function of pH at 25°C)
Version / remarks:
October 2008
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Specific details on test material used for the study:
The test item was heated to 40-50°C until complete melting of the crystallized part before being used in liquid form.
Radiolabelling:
no
Analytical monitoring:
yes
Buffers:
- pH: 4,7 and 9
- Type and final molarity of buffer:
Acetate buffer 0.01 M
Phosphate buffer 0.01 M
Borate buffer 0.01M
- Composition of buffer:
Acetate buffer: 16.7% of 0.01M sodium acetate, 83.3% of acetic acid in water and 0.0009% (w/v) sodium azide
Phosphate buffer:0.01 M potassium di-hydrogen-phosphate solution in water adjusted to pH 7 using 1N sodium hydroxide. Buffer contained 0.0009% (w/v) sodium azide.
Borate buffer:0.01 M potassium di-hydrogen-phosphate solution in water adjusted to pH 7 using 1N sodium hydroxide. Buffer contained 0.0009% (w/v) sodium azide.
Details on test conditions:
TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: sterile vessel
- Lighting: no light during the test
- Measures taken to avoid photolytic effects: test performed in the dark
- Measures to exclude oxygen: nitrogen gas
- Is there any indication of the test material adsorbing to the walls of the test apparatus? No

TEST MEDIUM
- Kind and purity of water: tap water purified by a Milli-Q water purification system
- Preparation of test medium: Test item solution spiked in setrile buffers solution using a spiking solution in acetonitrile
- Renewal of test solution: No
- Identity and concentration of co-solvent: Acetonitrile
Duration:
21.2 d
pH:
4
Temp.:
20 °C
Initial conc. measured:
>= 112 - <= 120 µg/L
Duration:
8.1 d
pH:
4
Temp.:
40 °C
Initial conc. measured:
>= 107 - <= 117 µg/L
Duration:
5.1 d
pH:
4
Temp.:
50 °C
Initial conc. measured:
>= 97.3 - <= 100 µg/L
Duration:
21.2 d
pH:
7
Temp.:
20 °C
Initial conc. measured:
>= 113 - <= 125 µg/L
Duration:
4 d
pH:
7
Temp.:
40 °C
Initial conc. measured:
>= 119 - <= 123 µg/L
Duration:
5.1 d
pH:
7
Temp.:
50 °C
Initial conc. measured:
>= 107 - <= 109 µg/L
Duration:
14.1 d
pH:
9
Temp.:
20 °C
Initial conc. measured:
>= 97.5 - <= 111 µg/L
Duration:
2.1 d
pH:
9
Temp.:
40 °C
Initial conc. measured:
>= 114 - <= 115 µg/L
Duration:
1 d
pH:
9
Temp.:
50 °C
Initial conc. measured:
>= 97.2 - <= 99.1 µg/L
Number of replicates:
2 replicates for each pH-temperature conditions
Statistical methods:
Nth-Order Rate or Intermediate Order Rate Equation (IORE) model to determine DT50
Preliminary study:
At pH 4, pH 7 and pH 9, a degree of hydrolysis of ≥ 10% was observed after 5 days.
Test performance:
The main test was performed at pH 4, 7 and 9 at 20, 40 and 50°C.
Transformation products:
not measured
% Recovery:
> 74 - < 80
pH:
4
Temp.:
20 °C
Duration:
0 s
% Recovery:
> 72 - < 78
pH:
4
Temp.:
40 °C
Duration:
0 s
% Recovery:
> 65 - < 67
pH:
4
Temp.:
50 °C
Duration:
0 s
% Recovery:
> 75 - < 83
pH:
7
Temp.:
20 °C
Duration:
0 s
% Recovery:
> 79 - < 82
pH:
7
Temp.:
40 °C
Duration:
0 s
% Recovery:
> 71 - < 73
pH:
7
Temp.:
50 °C
Duration:
0 s
% Recovery:
> 65 - < 74
pH:
9
Temp.:
20 °C
Duration:
0 s
% Recovery:
> 76 - < 77
pH:
9
Temp.:
40 °C
Duration:
0 s
% Recovery:
> 65 - < 66
pH:
9
Temp.:
50 °C
Duration:
0 s
Key result
pH:
4
Temp.:
20 °C
Half-life:
21.1 h
Type:
other: Intermediate Order Rate
Key result
pH:
4
Temp.:
40 °C
Half-life:
1.62 h
Type:
other: Intermediate Order Rate
Key result
pH:
4
Temp.:
50 °C
Half-life:
0.576 h
Type:
other: Intermediate Order Rate
Key result
pH:
7
Temp.:
20 °C
Half-life:
9.61 h
Type:
other: Intermediate Order Rate
Key result
pH:
7
Temp.:
40 °C
Half-life:
0.798 h
Type:
other: Intermediate Order Rate
Key result
pH:
7
Temp.:
50 °C
Half-life:
0.386 h
Type:
other: Intermediate Order Rate
Key result
pH:
9
Temp.:
20 °C
Half-life:
51.7 h
Type:
other: Intermediate Order Rate
Key result
pH:
9
Temp.:
40 °C
Half-life:
1.84 h
Type:
other: Intermediate Order Rate
Key result
pH:
9
Temp.:
50 °C
Half-life:
0.752 h
Type:
other: Intermediate Order Rate
Details on results:
TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes

Conclusions:
The test item is hydrolysed at pH4, 7 and 9 for all the temperature tested (20, 40 and 50°C).
Executive summary:

The behavior of the test item regarding hydrolysis was determined according to recognised guideline and under GLP.

No deviation from the guideline was observed during the study.

The disappearance time 50 (DT50) were calculated according to the Nth-Order Rate or Intermediate Order Rate Equation (IORE) model using Computer Aided Kinetic Evaluation (CAKE) Version 3.3.

The DT50 are detailed in the table below:

 pH  Temperature (°C)  DT50 (Hours)
 4 20  21.1
 4 40 1.62
 4 50  0.576
 7  20  9.61
 7  40  0.789
 7  50 0.386 
 9  20  51.7
 9  40  1.84
 9  50  0.752

Description of key information

The hydrolysis of the test item was determined in experimental key study (Klimisch validity one, according to recognised guidelines).

Key value for chemical safety assessment

Half-life for hydrolysis:
9.61 h
at the temperature of:
20 °C

Additional information

The disappearance time 50 (DT50) were calculated according to the Nth-Order Rate or Intermediate Order Rate Equation (IORE) model using Computer Aided Kinetic Evaluation (CAKE) Version 3.3.

The DT50 are detailed in the table below:

 pH  Temperature (°C)  DT50 (Hours)
 4 20  21.1
 4 40 1.62
 4 50  0.576
 7  20  9.61
 7  40  0.789
 7  50 0.386 
 9  20  51.7
 9  40  1.84
 9  50  0.752