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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:
2016-09-20 to 2017-04-10
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
Qualifier:
according to guideline
Guideline:
EPA OPPTS 835.2120 (Hydrolysis of Parent and Degradates as a Function of pH at 25°C)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: I15FB3131
- Expiration date of the lot/batch: 2017-06-11 (retest date)
- Purity: 100% (based on base titration assay)
- Purity test date: 2015-09-04

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under test conditions: no data
Radiolabelling:
no
Analytical monitoring:
yes
Details on sampling:
- Sampling intervals for the parent/transformation products:
* For tier one, immediately after the preparation and on the fifth day
* For tier two, immediately after the preparation and several times later
- Sampling method: The samples were diluted in a 8:1:1 (v:v:v) ratio with 7.5% NH4Ac in water and 5% formic acid in methanol and analysed.
- Sampling intervals/times for pH measurements: at the beginning and end of the tests
- Sample storage conditions before analysis: at room temperature
Buffers:
- pH:
* Acetate buffer pH 4, 0.1 M: A solution of 16.7% 0.1 M sodium acetate in water and 83.3% 0.1 M acetic acid in water. The buffer contained 0.0009% (w/v) sodium azide.
* Phosphate buffer pH 7, 0.1 M: A solution of 0.1 M potassium di-hydrogenphosphate in water adjusted to pH 7 using 10 or 1 N sodium hydroxide. The buffer contained 0.0009% (w/v) sodium azide.
* Borate buffer pH 9, 0.1 M: A solution of 0.1 M boric acid in water and 0.1 M potassium chloride in water adjusted to pH 9 using 1or 10 N sodium hydroxide. The 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
- Sterilisation method: each solution was filter-sterilised through a 0.2 µm FP 30/0.2 CA-S filter (Whatman, Dassel, Germany) and transferred into a sterile vessel.
- Lighting: in the dark
- Measures taken to avoid photolytic effects: vessels placed in the dark
- Measures to exclude oxygen: Nitrogen was passed through the buffer solutions for about 5 minutes.
- If no traps were used, is the test system closed/open: under vacuum
- Is there any indication of the test material adsorbing to the walls of the test apparatus? no

TEST MEDIUM
- Volume used/treatment: 6 mL
- Kind and purity of water: Tap water purified by a Milli-Q water purification system (Millipore, Bedford, MA, USA)
- Renewal of test solution: not applicable
- Identity and concentration of co-solvent: not applicable

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Dissolved oxygen: no data
Duration:
788.13 h
pH:
4
Temp.:
20 °C
Initial conc. measured:
10.5 mg/L
Duration:
644.48 h
pH:
4
Temp.:
50 °C
Initial conc. measured:
ca. 9.77 mg/L
Duration:
192.13 h
pH:
4
Temp.:
60 °C
Initial conc. measured:
ca. 9.93 mg/L
Duration:
787.97 h
pH:
7
Temp.:
20 °C
Initial conc. measured:
10.5 mg/L
Duration:
143.62 h
pH:
7
Temp.:
50 °C
Initial conc. measured:
10.1 mg/L
Duration:
46.18 h
pH:
7
Temp.:
60 °C
Initial conc. measured:
10 mg/L
Duration:
28.12 h
pH:
9
Temp.:
20 °C
Initial conc. measured:
10.3 mg/L
Duration:
72.87
pH:
9
Temp.:
40 °C
Initial conc. measured:
ca. 10.05 mg/L
Duration:
68.58 h
pH:
9
Temp.:
50 °C
Initial conc. measured:
ca. 10.55 mg/L
Number of replicates:
Calibration solutions were injected in duplicate. Test samples were analysed by single injection.
Positive controls:
no
Negative controls:
no
Statistical methods:
No data
Preliminary study:
A degree of hydrolysis of ≥ 10% was observed at pH 4, pH 7 and pH 9 after 5 days. According to the guideline, the higher Tier test was required to determine the half-life time of the test item.
The mean recoveries of the test item containing buffer solutions at t=0 slightly exceeded the criterion range of 90-110% (i.e. 114, 116 and 113%). At all pH’s the degree of degradation clearly exceeded 10%.
Transformation products:
not measured
% Recovery:
105
pH:
4
Temp.:
20 °C
Duration:
788.13 h
% Recovery:
98
pH:
4
Temp.:
50 °C
Duration:
644.48 h
% Recovery:
99
pH:
4
Temp.:
60 °C
Duration:
192.13 h
% Recovery:
105
pH:
7
Temp.:
20 °C
Duration:
787.97 h
% Recovery:
101
pH:
7
Temp.:
50 °C
Duration:
143.62 h
% Recovery:
100
pH:
7
Temp.:
60 °C
Duration:
46.18 h
% Recovery:
103
pH:
9
Temp.:
20 °C
Duration:
28.12 h
% Recovery:
101
pH:
9
Temp.:
40
Duration:
72.87 h
% Recovery:
106
pH:
9
Temp.:
50 °C
Duration:
68.58 h
pH:
4
Temp.:
20 °C
DT50:
335 d
Key result
pH:
7
Temp.:
20 °C
DT50:
9.1 d
pH:
9
Temp.:
20 °C
DT50:
8 h

The results of the hydrolysis as a function of pH of the test item are:

 Parameter  Result

 Hydrolysis at pH 4       

t½ = 335 days at 20°C

t½ = 167 days at 25°C

t½ = 7.1 days at 50°C

t½ = 2.2 days at 60°C

 Hydrolysis at pH 7

t½ = 9.1 days at 20°C

t½ = 6.5 days at 25°C

t½ = 1.4 days at 50°C

t½ = 0.57 days at 60°C

 Hydrolysis at pH 9    

t½ = 8.0 hours at 20°C

t½ = 5.2 hours at 25°C

t½ = 1.6 hours at 40°C

t½ = 0.55 hours at 50°C

Validity criteria fulfilled:
yes
Conclusions:
Based on the guideline study (OECD 111) performed for the test item JNJ 119379-AAA (T001141) to estimate the hydrolysis at pH values normally found in the environment (pH 4-9), it is concluded that the half-life at 20°C at pH 4, 7 and 9 respectively were 335 days, 9.1 days and 8.0 hours. The results of the study can be considered reliable without restriction.

Description of key information

Based on the guideline study (Reingruber, 2017) performed for the test item JNJ 119379-AAA (T001141) to estimate the hydrolysis at pH values normally found in the environment (pH 4-9), it is concluded that the half-life at 20°C at pH 4, 7 and 9 respectively were 335 days, 9.1 days and 8.0 hours under the conditions of the test. Results of the study are reliable without restrictions.

Key value for chemical safety assessment

Half-life for hydrolysis:
9.1 d
at the temperature of:
20 °C

Additional information