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EC number: 403-530-4 | CAS number: 129423-54-7 PV-ECHTGELB HGR
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- According to Directive 84/449/EEC and GLP
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 84/449/EEC, annex V, C.10.
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Buffers:
- buffers were prepared as specified in Directive 84/449/EEC
- pH: 4
- Composition of buffer: aqueous solution of potassium biphthalate with 0.1 mol/L sodium hydroxide; adjusted to pH 4
- pH: 7
- Composition of buffer: aqueous solution of 0.05 mol/L potassium dihydrogenorthophosphate; adjusted to pH 7 with sodium hydroxide
- pH 9:
- Composition of buffer: solution of 0.05 mol/L boric acid in aqueous potassium chloride (0.05 mol/L) solution; adjusted to pH 9 with sodium hydroxide - Number of replicates:
- 1
- Preliminary study:
- Due to the low water solubilty of the test substance DMF was added to increase solubility (as specified in Directive 84/449/EEC)
A stock solution of 115 mg test substance in 100 mL DMF was prepared. 1 mL stock solution was added to a volumetric flask and filled up to 100 mL with the buffer solutions respectively.
In the preliminary test volumetric flasks were heated at 50°C for 2.4 h and 5 d. After heating the test solutions were cooled with ice and the concentrations were measured immediately. - Transformation products:
- not measured
- 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:
- According to the criteria of Directive 84/449/EEC the test substance is regarded as hydrolytically stable.
- Endpoint:
- hydrolysis
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reason / purpose for cross-reference:
- read-across source
- Transformation products:
- not measured
- 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
Referenceopen allclose all
Results preliminary test
Time duration |
pH |
Concentration start [mg/L] |
Concentration end [mg/L] |
Degradation [%] |
2.4 h |
4.0 |
11.4 |
11.3 |
0.7 |
2.4 h |
7.0 |
11.4 |
11.4 |
0.6 |
2.4 h |
9.0 |
11.4 |
11.3 |
1.2 |
5 d |
4.0 |
10.4 |
10.4 |
0 |
5 d |
7.0 |
10.4 |
10.2 |
1.6 |
5 d |
9.0 |
10.4 |
9.9 |
4.3 |
Description of key information
Hydrolysis
In the preliminary test degradation was below 10 % after 5 days (= t0.5> 1 year). Therefore, the test substance is regarded as hydrolytically stable at pH 4, 7 and 9 and no additional testing is required.
Key value for chemical safety assessment
Additional information
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