Registration Dossier
Registration Dossier
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EC number: 417-440-8 | CAS number: 2516-92-9
Hydrolysis
Administrative data
- Endpoint:
- hydrolysis
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- the study does not need to be conducted because the substance is highly insoluble in water
- Justification for type of information:
- The water solubility of the test substance (test no. 931530/01) is <0.0005 g/L.
Assuming this value represents the true order of magnitude, the detection limit of the analytical method must be at least at 1.25 x 10^-5 g/l (1/40 of the value of water solubility) to perform the hydrolysis test.
The factor of 40 is due to the fact that:
- the initial concentration for the hydrolysis test must not exceed half the saturation concentration
- the accuracy of the analytical method should be better than 5% of the initial concentration (e.g. to determine a 10% decomposition during the preliminary test)
It was not possible to develop an analytical method with such low a detection limit. For this reason and because only the upper limit of the water solubility was experimentally determinable, the hydrolysis test could not be performed.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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