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Hydrolysis

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Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12-12-2014 to 09-05-2015
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:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: PFW-120356
- Expiration date of the lot/batch: not supplied


STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark


Radiolabelling:
no
Analytical monitoring:
yes
Details on sampling:
- Sampling intervals for the parent/transformation products: 0h, 24h, 120h, 144h
- Sampling intervals/times for pH measurements: 0h, 24h, 120h, 144h

Buffers:
Buffer solution (pH 4):
- Citric acid 0.06 mol/dm³
- Sodium chloride 0.04 mol/dm³
- Sodium hydroxide 0.07 mol/dm³

Buffer solution (pH 7):
- Disodium hydrogen orthophosphate (anhydrous) 0.03 mol/dm³
- Potassium dihydrogen orthophosphate 0.02 mol/dm³
- Sodium chloride 0.02 mol/dm³

Buffer solution (pH 9):
- Disodium tetraborate 0.01 mol/dm³
- Sodium chloride 0.02 mol/dm³
Details on test conditions:
TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: stoppered glass flasks
- Sterilisation method: no data
- Lighting: the solutions were shielded from light while maintained at the test temperature
- Measures taken to avoid photolytic effects: vessels placed in the dark
- Measures to exclude oxygen: the solutions were subjected to ultrasonication and degassing with nitrogen to minimize dissolved oxygen content
- Details on test procedure for unstable compounds: no data
- Details of traps for volatile, if any : not applicable
- If no traps were used, is the test system closed/open : stoppered flasks
- Is there any indication of the test material adsorbing to the walls of the test apparatus? no data

TEST MEDIUM
- Volume used/treatment : no data
- Kind and purity of water: no data
- Preparation of test medium: no data
- Renewal of test solution: not applicable
- Identity and concentration of co-solvent: not applicable

OTHER TEST CONDITIONS
- Adjustment of pH: no data
- Dissolved oxygen: no data
Duration:
144 h
pH:
4
Temp.:
50 °C
Initial conc. measured:
1.84 - 1.87 g/L
Remarks:
final conc. 1.82 and 1.91 g/L
Duration:
144 h
pH:
7
Temp.:
50 °C
Initial conc. measured:
1.79 - 1.88 g/L
Remarks:
final conc. 1.48 and 0.947 g/L
Duration:
144 h
pH:
9
Temp.:
50 °C
Initial conc. measured:
1.91 - 1.94 g/L
Remarks:
final conc. 1.37 and 1.75 g/L
Number of replicates:
Duplicate aliquots (A and B) of each sample solution
Positive controls:
no
Negative controls:
no
Statistical methods:
no data
Preliminary study:
For the preliminary study, sample solutions at pH 4, 7 and 9 were maintained at 50.0 +/- 0.5°C for a period of 144 hours.
Results from the preliminary tier 1 test showed it was not necessary to undertake further testing at pH 4, pH 7 and pH 9.
Transformation products:
no
% Recovery:
98 - 103
pH:
4
Temp.:
50 °C
Duration:
144 h
Remarks on result:
hydrolytically stable based on preliminary test
% Recovery:
51.6 - 80.6
pH:
7
Temp.:
50 °C
Duration:
144 h
Remarks on result:
other: The 51.6% recovery was considered to be an outlier since it was out-of-agreement with the other time point samples. Therefore the replicate was not used in any subsequent calculations
% Recovery:
71.1 - 90.8
pH:
9
Temp.:
50 °C
Duration:
144 h
Remarks on result:
other: The 71.1% recovery was considered to be an outlier since it was out-of-agreement with the other time point samples. Therefore, the replicate was not used in any subsequent calculations.
pH:
4
Temp.:
25 °C
DT50:
> 1 yr
Key result
pH:
7
Temp.:
25 °C
DT50:
> 1 yr
pH:
9
Temp.:
25 °C
DT50:
> 1 yr
Validity criteria fulfilled:
yes
Conclusions:
The test substance was found to be hydrolytically stable at pH 4, pH 7 and pH 9 with an estimated half-life time greater than 1 year at 25°C, therefore no further testing was performed. The results of the test can be considered reliable without restriction.

Description of key information

Based on a study carried out according to the OECD guideline 111, the substance was found to be hydrolytically stable at pH 4, pH 7 and pH 9 with an estimated half-life time greater than 1 year at 25°C.

Key value for chemical safety assessment

Additional information