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Hydrolysis

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Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
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)
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
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: Product no. B4429, Lot no. SLBK5235V
- Expiration date of the lot/batch: 30 April 2018
- Purity test date: na

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

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no

Radiolabelling:
no
Analytical monitoring:
yes
Details on sampling:
- Sampling intervals for the parent/transformation products: 0 and 120h
- Sampling method: -
- Sampling methods for the volatile compounds, if any: not applicable
- Sampling intervals/times for pH measurements: 0 and 120h
- Sampling intervals/times for sterility check: not applicable
- Sample storage conditions before analysis: not applicable (no storage)
- Other observation, if any (e.g.: precipitation, color change etc.): none
Buffers:
- pH: 4, 7, 9
- Type and final molarity of buffer:
- Composition of buffer:
pH 4.0: 76.5 mL 0.1 M sodium acetate and 423.5 mL 0.1 M acetic acid;
pH 7.0: 250 mL 0.1 TRIS buffer and 233 mL 0.1 M hydrochlorid acid diluted to 500 mL with ultra-pure water;
pH 9.0: 53.5 mL 0.2 M sodium hydroxide and 125 mL 0.1 M boric acid and potassium chloride diluted to 500 mL with ultra-pure water)
Details on test conditions:
TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: 20 mL headspace vials
- Sterilisation method: sterile working conditions
- Lighting: no information available
- Measures taken to avoid photolytic effects: no information available
- Measures to exclude oxygen: test tubes were filled up with test solutions
- Details on test procedure for unstable compounds: not applicable
- Details of traps for volatile, if any: not applicable
- If no traps were used, is the test system closed/open: no information available
- Is there any indication of the test material adsorbing to the walls of the test apparatus? none
TEST MEDIUM
- Volume used/treatment: 20 mL
- Kind and purity of water: ultra-pure sterile water
- Preparation of test medium: 250 mg dissolved in each buffer solution to a total volume of 250 mL
- Renewal of test solution: none
- Identity and concentration of co-solvent: not applicable
Duration:
120 h
pH:
4
Temp.:
50 °C
Initial conc. measured:
0.99 µg/L
Duration:
120 h
pH:
7
Temp.:
50 °C
Initial conc. measured:
0.99 µg/L
Duration:
120 h
pH:
9
Temp.:
50 °C
Initial conc. measured:
0.95 µg/L
Number of replicates:
5 per pH
Positive controls:
no
Negative controls:
yes
Preliminary study:
Recovery after 120h at 50°C:
- pH 4: 105%
- pH 7: 95%
- pH 9: 96%
Therefore, it was concluded that the substance is hydrolytically stable and no further experiments were conducted.
Transformation products:
not measured
% Recovery:
100
pH:
4
Temp.:
50 °C
Duration:
120 h
Remarks on result:
hydrolytically stable based on preliminary test
% Recovery:
95
pH:
7
Temp.:
50 °C
Duration:
120 h
Remarks on result:
hydrolytically stable based on preliminary test
% Recovery:
96
pH:
9
Temp.:
50 °C
Duration:
120 h
Remarks on result:
hydrolytically stable based on preliminary test
Key result
Remarks on result:
hydrolytically stable based on preliminary test
Details on results:
TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes
- Anomalies or problems encountered (if yes):

MAJOR TRANSFORMATION PRODUCTS: - not applicable

MINERALISATION (distinguish between dark and irradiated samples): not applicable

INDICATION OF UNSTABLE TRANSFORMATION PRODUCTS: none

VOLATILIZATION (at end of study): none

UNIDENTIFIED RADIOACTIVITY (at end of study): not applicable

PATHWAYS OF HYDROLYSIS: not applicable

The hydrolysis of the substance as a function of pH was determined in a preliminary test according to OECD Test Guideline 111 under GLP conditions.

As no hydrolysis was observed at pH 4, 7 and 9 at 50°C for 120h, it was concluded that the substance is hydrolytically stable and the hydrolysis was not investigated further.

Validity criteria fulfilled:
yes
Executive summary:

The hydrolysis of the substance as a function of pH was determined in a preliminary test according to OECD Test Guideline 111 under GLP conditions.

As no hydrolysis was observed at pH 4, 7 and 9 at 50°C for 120h, it was concluded that the substance is hydrolytically stable and the hydrolysis was not investigated further.

Description of key information

In a preliminary test, the substance was hydrolytically stable.

Key value for chemical safety assessment

Additional information