Registration Dossier

Environmental fate & pathways

Hydrolysis

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-11-25 to 2015-11-30
Reliability:
1 (reliable without restriction)
Reference:
Composition 0
Qualifier:
according to
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 835.2120 (Hydrolysis of Parent and Degradates as a Function of pH at 25°C)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
See study report
Test material information:
Composition 1
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
* identification JNJ-16479489-AAA (T001159)
* batch: M14IB5308
- Expiration date of the lot/batch: 2016-02-03 (retest date)
- Purity test date: 2014-09-01

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
Radiolabelling:
no
Analytical monitoring:
yes
Details on sampling:
- Sampling intervals for the parent/transformation products:
* Tier 1: at the beginning and after 5 days

- Sampling method:
* Tier 1: Concentration of the test item in the test sample was determined immediately after preparation. The samples taken at t=5 days were cooled to room temperature using running tap water. Samples were diluted 1/1 (v/v) with methanol and analysed.
Buffers:
- pH:
* Tier 1: 4.0, 7.0, 9.0
- Type and final molarity and composition of buffer:
* Acetate buffer pH 4: 0.01 M A solution of 16.7%, 0.01 M sodium acetate in water and 83.3% 0.01 M acetic acid in water. The buffer contained 0.0009% (w/v) sodium azide.
* Phosphate buffer pH 7: 0.01 M A solution of 0.01 M potassium di-hydrogenphosphate in water adjusted to pH 7 using 1 N sodium hydroxide. The buffer contained 0.0009% (w/v) sodium azide.
* Borate buffer pH 9: 0.01 M A solution of 0.01 M boric acid in water and 0.01 M potassium chloride in water adjusted to pH 9 using 1 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.
- Temperature: 50.1°C ± 0.1°C.
- 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)
- Preparation of test medium: The test item was spiked to the solutions at a target concentration of 100 µg/l using a spiking solution in methanol.
- Renewal of test solution: not applicable
- Identity and concentration of co-solvent: not applicable
Duration:
5 d
pH:
4
Temp.:
50.1 °C
Initial conc. measured:
0.106 mg/L
Remarks:
Final conc. 0.103 mg/L
Duration:
5 d
pH:
4
Temp.:
50.1 °C
Initial conc. measured:
0.107 mg/L
Remarks:
Final conc. 0.103 mg/L
Duration:
5 d
pH:
7
Temp.:
50.1 °C
Initial conc. measured:
0.109 mg/L
Remarks:
Final conc. 0.104 mg/L
Duration:
5 d
pH:
7
Temp.:
50.1 °C
Initial conc. measured:
0.11 mg/L
Remarks:
Final conc. 0.102 mg/L
Duration:
5 d
pH:
9
Temp.:
50.1 °C
Initial conc. measured:
0.109 mg/L
Remarks:
Final conc. 0.103 mg/L
Duration:
5 d
pH:
9
Temp.:
50.1 °C
Initial conc. measured:
0.109 mg/L
Remarks:
Final conc. 0.104 mg/L
Number of replicates:
2 at each pH
Positive controls:
no
Negative controls:
no
Statistical methods:
no data
Preliminary study:
The preliminary hydrolysis test were performed at 50.2 ± 0.1 °C. At pH 4, pH 7 and pH 9 a degree of hydrolysis of < 10% was observed after 5 days. It demonstrated that the half-life time of the test item at 25°C is > 1 year. According to the guideline, no further tests were required.
Transformation products:
no
% Recovery:
107
pH:
4
Temp.:
50.2 °C
Duration:
5 d
Remarks on result:
hydrolytically stable based on preliminary test
% Recovery:
109
pH:
7
Temp.:
50.2 °C
Duration:
5 d
Remarks on result:
hydrolytically stable based on preliminary test
% Recovery:
109
pH:
9
Temp.:
50.2 °C
Duration:
5 d
Remarks on result:
hydrolytically stable based on preliminary test
Key result
pH:
4
Temp.:
25 °C
Half-life:
> 1 yr
Key result
pH:
7
Temp.:
25 °C
Half-life:
> 1 yr
Key result
pH:
9
Temp.:
25 °C
Half-life:
> 1 yr
Validity criteria fulfilled:
yes
Remarks:
No test item was detected in the blank buffer solutions. The mean recoveries of the buffer solut ions fell within the criterion range of 90-110%. It demonstrated that the analytical method was ade quate to support the hydrolysis study on the test item.
Conclusions:
T001159 was found to be hydrolytically stable at pH 4.0, pH 7.0 and pH 9.0 with a degree of hydrolysis of < 10% after 5 days. It demonstrated that the half-life time of the test item at 25°C is > 1 year and the test item was considered hydrolytically stable. Therefore, no further testing was performed. The results of the test can be considered reliable without restriction.

Description of key information

One study (Reingruber, 2016) was performed according to OECD guideline 111 and regarded as a key study (Klimisch score of 1).

T001159 was found to be hydrolytically stable at pH 4.0, pH 7.0 and pH 9.0 with a degree of hydrolysis of < 10% after 5 days. It demonstrated that the half-life time of the test item at 25°C is > 1 year and the test item was considered hydrolytically stable. Therefore, no further testing was performed. The results of the test can be considered reliable without restriction.

Key value for chemical safety assessment

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

Additional information