Registration Dossier

Diss Factsheets

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:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
A) The study was conducted according to OECD Guideline 111. B) Well-defined information were provided on: 1. Compositional information of the test substance 2. Test methods used in the study 3. Description of methodologies 4. Test results 5. Definite conclusion
Qualifier:
according to guideline
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Deviations:
no
GLP compliance:
not specified
Analytical monitoring:
yes
Details on sampling:
- Sampling intervals for the parent/transformation products: All samples from control at 5°C, control at 50°C and buffer solutions were analysed for total Formate concentration after 5 days.
- Sampling method: No details available
- Sampling methods for the volatile compounds, if any: Not applicable
- Sampling intervals/times for pH measurements: No data on pH measurements
- Sampling intervals/times for sterility check: Not applicable
- Sample storage conditions before analysis: Samples were immediately analysed after the test period of 5 days.
- Other observation, if any (e.g.: precipitation, color change etc.): None
Buffers:
- pH: 4.0
- Type and final molarity of buffer: No data
- Composition of buffer: 2 mL of 0.1 N NaOH and 250 mL of 0.1 M Potassium Biphthalate were mixed and diluted to 500 mL with sterilised deionised water
- pH: 7.0
- Type and final molarity of buffer: No data
- Composition of buffer: 148.2 mL of 0.1 N NaOH and 250 mL of 0.1 M Monopotassium Phosphate were mixed and diluted to 500 mL with sterilised deionised water
- pH: 9.0
- Type and final molarity of buffer: No data
- Composition of buffer: 106.5 mL of 0.1 N NaOH and 250 mL of 0.1 M H3BO3 in 0.1 M KCl were mixed and diluted to 500 mL with sterilised deionised water
Estimation method (if used):
The pH of the buffer solution is estimated by pH meter
Details on test conditions:
TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: 100 mL glass volumetric flasks containing 100 mL of the test solution
- Sterilisation method: Autoclaving
- Measures taken to avoid photolytic effects: The water bath was housed in black plastic covered fume hood to avoid photolytic reaction
- Measures to exclude oxygen: All the flasks were sparged with nitrogen gas for 2 min
Duration:
5 d
pH:
4
Initial conc. measured:
ca. 0.008 mol/L
Duration:
5 d
pH:
7
Initial conc. measured:
ca. 0.008 mol/L
Duration:
5 d
pH:
9
Initial conc. measured:
ca. 0.008 mol/L
Duration:
5 d
Temp.:
5 °C
Initial conc. measured:
0.008 mol/L
Duration:
5 d
Initial conc. measured:
ca. 0.008 mol/L
Number of replicates:
Duplicate
Positive controls:
yes
Remarks:
Flasks (in duplicate) containing test solution diluted with deionised water without buffer were kept at 5°C and 50°C for 5 d
Negative controls:
no
Preliminary study:
The mean final concentration of the test substance solution in the control was 0.0086 M, in the blank test substance solution without buffer at 50 °C was 0.0083 M, and in all three buffered test solutions (pH 4.0, 7.0 and 9.0) was 0.0084 M.
Test performance:
The Formate concentrations in the buffered test solutions at 50 °C were very close to the initially added. The relative differences in the Formate concentrations between the buffered test solutions and the control at 5 °C were less than 3%.
Transformation products:
not specified
Details on hydrolysis and appearance of transformation product(s):
Not applicable
% Recovery:
ca. 97
pH:
4
Temp.:
50 °C
Duration:
ca. 5 d
% Recovery:
ca. 97
pH:
7
Temp.:
50 °C
Duration:
ca. 5 d
% Recovery:
ca. 97
pH:
9
Temp.:
50 °C
Duration:
ca. 5 d
Key result
Remarks on result:
hydrolytically stable based on preliminary test
Details on results:
The Formate concentrations in the buffered test solutions at 50°C were very close to that initially added. The relative differences in the Formate concentrations between the buffered test solutions and the control at 5°C were less than 3%.

Table 1. Final concentrations of Formate in the controls and buffered test solutions after 5 days

 Test Condition    Final concentration   Final concentration  Relative to Control at 5°C
      (M)  (M)  %
 Control  5°C  0.0084  0.0086  -
     0.0087    
Control  50°C  0.0082  0.0083 -3.5
     0.0084    
 Buffer pH 4.0  50 °C  0.0085  0.0084 -2.3
     0.0083    
 Buffer pH 7.0  50°C  0.0083  0.0084 -2.3
     0.0085    
 Buffer pH 9.0  50 °C  0.0084  0.0084 -2.3 
    0.0084     
Validity criteria fulfilled:
not specified
Remarks:
1. Duplicate buffered test solutions were used. 2. Recovery of test material was within recommended range (90-110 %).
Conclusions:
Under the study conditions the test substance solution was considered to be hydrolytically stable.
Executive summary:

A study was conducted to determine the hydrolytic stability of the test substance solution according to OECD Guideline 111. 0.1 M of the test substance solution was mixed with pH 4.0, 7.0 and 9.0 buffered solutions in duplicate 100 mL volumetric flasks and kept in a light-protected water bath at 50±0.1°C for 5 days. Concurrent controls without buffers were also kept at 50±0.1°C and 5°C for 5 days. All samples were analysed in HPLC for total formate concentration immediately after removal from water bath. The relative differences in the formate concentrations between the buffer pH solutions and the control at 5°C were less than 3%. Under the study conditions the test substance solution was considered to be hydrolytically stable (Gibb, 1998).

Description of key information

Key value for chemical safety assessment

Additional information

A study was conducted to determine the hydrolytic stability of the test substance solution according to OECD Guideline 111. 0.1 M of the test substance solution was mixed with pH 4.0, 7.0 and 9.0 buffered solutions in duplicate 100 mL volumetric flasks and kept in a light-protected water bath at 50±0.1°C for 5 days. Concurrent controls without buffers were also kept at 50±0.1°C and 5°C for 5 days. All samples were analysed in HPLC for total formate concentration immediately after removal from water bath. The relative differences in the formate concentrations between the buffer pH solutions and the control at 5°C were less than 3%. Under the study conditions the test substance solution was considered to be hydrolytically stable (Gibb, 1998).