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Hydrolysis

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Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 December 2006 to 13 June 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Deviations:
no
GLP compliance:
yes
Radiolabelling:
not specified
Analytical monitoring:
yes
Details on sampling:
- Sampling method: About 40 mg of the test substance were dissolved in 2 mL solubilizer (acetone, acetonitrile and ethanol) and filled up to 100 mL with the respective buffer solution (pH 4.0, pH 7.0 and pH 9.0). Each mixture was ultrasonified and submitted to a 0.2 μm filtration. To obtain a test solution of not more than half the water solubility, one part of the solution was diluted with one part of the respective buffer.
Buffers:
- pH: 4.0, 7.0 and 9.0
Details on test conditions:
None stated
Number of replicates:
None stated
Positive controls:
not specified
Negative controls:
not specified
Statistical methods:
None stated
Preliminary study:
The solubility of the test substance in the buffer solutions pH 4, pH 7.0 and pH 9.0 is very low, therefore a test with different solubilizer was performed to increase the solubility of the test substance.

It was not possible to increase the solubility of the test item with the use of different solubilizers. Peaks obtained, if any, were too small to allow quantification or even to follow a degradation curve.

According to the EEC Directive 92/69 Section C.7, 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 on the substance at pH 4, pH 7 and pH 9.
Transformation products:
not specified
Details on hydrolysis and appearance of transformation product(s):
No information on hydrolysis was acheived in the test due to solubility.
Remarks on result:
other: No information on hydrolysis was acheived in the test due to solubility.
Remarks on result:
not measured/tested
Remarks:
The solubility of the test substance in the buffer solutions pH 4, pH 7.0 and pH 9.0 is very low, therefore a test with different solubilizer was performed to increase the solubility of the test substance. It was not possible to increase the solubility of the test item with the use of different solubilizers. Peaks obtained, if any, were too small to allow quantification or even to follow a degradation curve. According to the EEC Directive 92/69 Section C.7, 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 on the substance at pH 4, pH 7 and pH 9.
Details on results:
The solubility of the test substance in the buffer solutions pH 4.0, pH 7.0 and pH 9.0 was very low. It was not possible to increase the solubility of the test substance with the use of different solubilizers (acetone, acetonitrile and ethanol).

Peaks obtained, if any, were too small to allow quantification or even to follow a degradation curve.

According to the EEC Directive 92/69 Section C.7, 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 on the substance at pH 4, pH 7 and pH 9.

The solubility of the test substance in the buffer solutions pH 4, pH 7.0 and pH 9.0 is very low, therefore a test with different solubilizer was performed to increase the solubility of the test substance.

It was not possible to increase the solubility of the test item with the use of different solubilizers. Peaks obtained, if any, were too small to allow quantification or even to follow a degradation curve.

According to the EEC Directive 92/69 Section C.7, 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 on the substance at pH 4, pH 7 and pH 9.

Validity criteria fulfilled:
yes
Conclusions:
In an OECD 111 study conducted to GLP, the solubility of the test item in the buffer solutions pH 4.0, pH 7.0 and pH 9.0 was very low. It was not possible to increase the solubility of the test substance with the use of different solubilizers (acetone, acetonitrile and ethanol). Peaks obtained, if any, were too small to allow quantification or even to follow a degradation curve.

According to the EEC Directive 92/69 Section C.7, 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 on the substance at pH 4, pH 7 and pH 9. (RCC Ltd, 2007).

Description of key information

In an OECD 111 study conducted to GLP, the solubility of the test item in the buffer solutions pH 4.0, pH 7.0 and pH 9.0 was very low. It was not possible to increase the solubility of the test substance with the use of different solubilizers (acetone, acetonitrile and ethanol). Peaks obtained, if any, were too small to allow quantification or even to follow a degradation curve.

According to the EEC Directive 92/69 Section C.7, 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 on the substance at pH 4, pH 7 and pH 9. (RCC Ltd, 2007).

Key value for chemical safety assessment

Additional information