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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

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.

Key value for chemical safety assessment

Additional information