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Hydrolysis

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Reference
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
- Name of test material (as cited in study report): T002615
- Appearance: solid white
- Analytical purity: > 98 %
- Lot/batch No.: 00403487
- Expiration date of the lot/batch: 31 December 2003
- Storage condition of test material: at room temperature at about 20°C
Radiolabelling:
no
Buffers:
- pH: 4, 7, 9
- Type and final molarity of buffer: buffer pH 4 biphthalate, buffer pH 7 phosphate, buffer pH 9 borate, no final molarity reported
- Composition of buffer: no data
Details on test conditions:
TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: glass flasks which were stoppered or sealed with an inert material
- Measures to exclude oxygen: Nitrogen was passed through the buffer solutions for 2 minutes except when freshly sterilized.

TEST MEDIUM
- Volume used/treatment: 50 mL
- Preparation of test medium:
The solubility of T002615 in the buffer solutions pH 4, 7, 9 is very low, therefore a test with different solubilizers was performed to increase the solubility of T002615.

Preparation of the test solutions with DMF as solubilizer:
13.97 mg, 12.22 mg and 12.24 mg of T002615 were each dissolved in 2 mL DMF and filled up to 100 mL with the respective buffer solution (pH 4, 7, 9).
Preparation of the test solutions with acetonitrile as solubilizer:
14.50 mg, 12.03 mg and 12.82 mg of T002615 were each dissolved in 2 mL acetonitrile and filled up to 100 mL with the respective buffer solution (pH 4, 7, 9).
Preparation of the test solutions with DMSO as solubilizer:
12.28 mg, 12.29 mg and 12.59 mg of T002615 were each dissolved in 2 mL DMSO and filled up to 100 mL with the respective buffer solution (pH 4, 7, 9).
Preparation of the test solutions with THF as solubilizer:
12.92 mg, 12.80 mg and 14.09 mg of T002615 were each dissolved in 2 mL THF and filled up to 100 mL with the respective buffer solution (pH 4, 7, 9).

These solutions were ultrasonificated for 10 minutes. To obtain test solutions of not more than half the water solubility, the solutions were diluted 1:1 with the respective buffer. Two aliquots of each test solution of approximately 50 mL each were transferred into 50 mL Erlenmeyer flasks in order to perform duplicate tests.
Details on results:
The test item was dissolved in the buffer solutions at pH 4, 7 and 9. The concentration of the test item was determined as a function of time at each pH. The solubility of T002615 in the buffer solutions pH 4, 7 and 9 was very low. It was not possible to increase the solubility of the test item with the use of different solubilizers (DMF, acetonitrile, DMSO and THF). Peaks obtained, if any, were too small to follow a degradation curve or even to allow quantification.
Conclusions:
The solubility of T002615 in the buffer solutions pH 4, 7 and 9 was very low. It was not possible to increase the solubility of the test item with the use of different solubilizers (DMF, acetonitrile, DMSO and THF). Peaks obtained, if any, were too small to follow a degradation curve or even to allow quantification. According to the EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH), the method is applicable only to water soluble substances. The test item shows no significant solubility in the different solvent systems. Therefore, no further testing could be performed with T002615 at pH 4, 7 and 9.

Description of key information

Based on the guideline study (Tognucci, 2003) it is concluded that a hydrolysis study for the test item (T002615) cannot be performed. The solubility of T002615 in the buffer solutions pH 4, 7 and 9 was very low. It was not possible to increase the solubility of the test item with the use of different solubilizers (DMF, acetonitrile, DMSO and THF). Peaks obtained, if any, were too small to follow a degradation curve or even to allow quantification. According to the EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH), the method is applicable only to water soluble substances. The test item shows no significant solubility in the different solvent systems. Therefore, no further testing could be performed with T002615 at pH 4, 7 and 9.

Key value for chemical safety assessment

Additional information