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EC number: - | CAS number: -
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 December 2015 to 08 March 2016
- 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)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 835.2120 (Hydrolysis of Parent and Degradates as a Function of pH at 25°C)
- Principles of method if other than guideline:
- Only a preliminary test was performed.
- GLP compliance:
- yes
- Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent products: at start and day 5
- Sampling method: in duplicate
- Sampling intervals/times for pH measurements: at start and day 5
- Sample storage conditions before analysis: analyzed immediately - Buffers:
- Acetate buffer pH 4, 0.01 M:
solution of 16.7% (v/v) 0.01 M sodium acetate in water and 83.3% (v/v) 0.01 M acetic acid in water. The buffer contains 0.0009% (w/v) sodium azide.
Phosphate buffer pH 7, 0.01 M:
solution of 0.01 M potassium di-hydrogenphosphate in water adjusted to pH 7 using 1 N sodium hydroxide. The buffer contains 0.0009% (w/v) sodium azide.
Borate buffer pH 9, 0.01 M :
solution of 0.01 M boric acid in water and 0.01 M potassium chloride in water adjusted to pH 9 using 1 N sodium hydroxide. The buffer contains 0.0009% (w/v) sodium azide - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: sterile vessel containing 6 mL test solution
- Sterilisation method: filter-sterilised through a 0.2 µm FP 30/0.2 CA-S filter (Whatman, Dassel, Germany)
- Lighting: in dark (all test solutions were protected from light at any time)
- Measures to exclude oxygen: nitrogen gas purged through solution
- Is there any indication of the test material adsorbing to the walls of the test apparatus; no
- Test temperature: 50.0°C ± 0.1°C
TEST MEDIUM
- Volume used/treatment: 6 mL (1.00 mg/L)
- Kind and purity of water: milli-Q water
- Preparation of test medium: sterilised through a 0.2 um filter - Number of replicates:
- 2 replicates/ pH-value
- Positive controls:
- no
- Negative controls:
- not specified
- Remarks:
- blanks were included but not reported
- Statistical methods:
- NA
- Preliminary study:
- Hydrolysis was < 10% at all pH values. The concomittant t1/2 is > 1 year at 25 °C
- Test performance:
- In view of the results of the preliminary study no further tests were performed
- Transformation products:
- not measured
- % Recovery:
- 96.4
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- 91.1
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- 102.4
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 4
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 7
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 9
- Remarks on result:
- hydrolytically stable based on preliminary test
- Validity criteria fulfilled:
- yes
- Conclusions:
- The hydrolysis rate of the substance at pH 4, 7 and 9 is >1 year
- Executive summary:
In a hydrolysis study performed according to OECD 111, the preliminary test at pH 4, 7 and 9 showed hydrolysis < 10% at 50 °C over the 5 day test period..
It can therefore be concluded that the hydrolysis rate of the substance at all tested pH values is > 1 year.
Reference
Preliminary hydrolysis test of the test substance at pH 4, pH 7 and pH 9
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Description of key information
In a hydrolysis study performed according to OECD 111, the preliminary test at pH 4, 7 and 9 showed hydrolysis < 10% at 50 °C over the 5 day test period..
The substance is considered hydrolytically stable.
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 1 yr
- at the temperature of:
- 25 °C
Additional information
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