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EC number: 239-269-6 | CAS number: 15217-42-2
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See read-across justification in Section 13.2.
- Reason / purpose for cross-reference:
- assessment report
- Reason / purpose for cross-reference:
- read-across source
- Preliminary study:
- After 5 days (120 h) at 50 +/-0.5 °C the concentrations of the test item was about 100 % of the start concentrations at pH 4,7, and 9. Thus the test item can be considered to be hydrolytically stable.
- Test performance:
- Due to the results of the tier 1 test no higher tier tests were conducted.
- Transformation products:
- no
- % Recovery:
- 99.2
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 5 d
- % Recovery:
- 101.1
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 5 d
- % Recovery:
- 100
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 5 d
- 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
at pH4:
- no transformation products observed, recovery 100 %
at pH7:
- no transformation products observed, recovery 100 %
at pH9:
- no transformation products observed, recovery 100 % - Validity criteria fulfilled:
- yes
- Conclusions:
- After 5 days (120 h) at 50 +/-0.5 °C the concentrations of the test item was about 100 % of the start concentrations at pH 4,7, and 9. Thus the test item can be considered to be hydrolytically stable.
- Executive summary:
The hydrolysis of the test item was investigated in accordance with OECD Guideline 111 (Hydrolysis as a function of pH). After 5 days (120 h) at 50 +/-0.5 °C the concentrations of the test item was about 100 % of the start concentrations at pH 4,7, and 9. Thus the test item can be considered to be hydrolytically stable.
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD 111
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: 3 samples were taken for measurements at the beginning of the test and after 5 days
- Sampling intervals/times for sterility check: The buffered solutions of the test items were sterilised by filtration using sterile 0.2 filters. For each sampling time, fresh tubes were used to avoid microbial contamination and contact with oxygen.
- Sample storage conditions before analysis: The solutions were stored at 50 +/- 0.5°C. - Buffers:
- The buffer solutions were prepared on the basis of the recommended compositions of the annex of the OECD method (buffer solutions 7 and 9) resp. Küster et al. (buffer solution 4). All chemicals used were of analytical grade. The pH was measured with a pH-meter with an uncertainty of 0.01 units and pH was adjusted to the nominal pH value ± 0.02 units.
Buffer-Solution, pH 4
- CH3COOH, 2-m (160 mL)
- CH3COONa, 1-m (80 mL)
- Water (ad 2000 mL)
Buffer-Solution, pH 7
- KH2PO4 (17.4171 g)
- Water (500 mL)
- NaOH, 2-m (29.8 mL)
- Water (ad 2000 mL)
Buffer-Solution, pH 9
- H3BO3 (6.1863 g)
- KCl (7.4579 g)
- Water (1000 mL)
- NaOH, 2-m (21.5 mL)
- Water (ad 2000 mL) - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: sterilised vials
- Sterilisation method: the solution of the buffered test solution was filtrated using sterilised 0.2 µm filters; all glassware was autoclaved before use.
- Measures taken to avoid photolytic effects: the tubes containing solutions were stored in an incubation chamber.
- Measures to exclude oxygen: sterilised vials were filled with the solutions and purged with oxygen-free argon. Fresh tubes were used for each for each sampling time to avoid microbial contamination and contact with oxygen.
- There was no indication of the test material adsorbing to the walls of the test.
TEST MEDIUM
- Preparation of test medium: the solution of the test item was mixed 1:1 with the appropriate buffer solution
OTHER TEST CONDITIONS
- Oxygen was excluded by purging the vials with oxygen-free argon during preparation. - Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 100
- Number of replicates:
- 3
- Preliminary study:
- After 5 days (120 h) at 50 +/-0.5 °C the concentrations of the test item was about 100 % of the start concentrations at pH 4,7, and 9. Thus the test item can be considered to be hydrolytically stable.
- Test performance:
- Due to the results of the tier 1 test no higher tier tests were conducted.
- Transformation products:
- no
- % Recovery:
- 99.2
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 5 d
- % Recovery:
- 101.1
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 5 d
- % Recovery:
- 100
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 5 d
- 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
at pH4:
- no transformation products observed, recovery 100 %
at pH7:
- no transformation products observed, recovery 100 %
at pH9:
- no transformation products observed, recovery 100 % - Validity criteria fulfilled:
- yes
- Conclusions:
- After 5 days (120 h) at 50 +/-0.5 °C the concentrations of the test item was about 100 % of the start concentrations at pH 4,7, and 9. Thus the test item can be considered to be hydrolytically stable.
- Executive summary:
The hydrolysis of the test item was investigated in accordance with OECD Guideline 111 (Hydrolysis as a function of pH). After 5 days (120 h) at 50 +/-0.5 °C the concentrations of the test item was about 100 % of the start concentrations at pH 4,7, and 9. Thus the test item can be considered to be hydrolytically stable.
Referenceopen allclose all
Description of key information
Based on the information available on source substance 1H-Benzotriazole, sodium benzotriazolate is considered to be hydrolytically stable under environmental conditions. Thus half-life in water was set to default value (OECD guideline 111).
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 365 d
- at the temperature of:
- 20 °C
Additional information
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