Rabitle FP-100

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31st Jan to 12th june 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: - Study generated according to generally valid and/or internationally accepted testing guidelines - Performed according to GLP - Test parameters based on specific testing guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 111 (Hydrolysis as a Function of pH)

Deviations:

no

Principles of method if other than guideline:

OECD Guideline for Testing of Chemicals No. 111, “Hydrolysis as a Function of pH; adopted April 13, 2004 (only at pH 4.0, pH 7.0 and pH 9.0).

EEC Directive 92/69, Section C.7, “Abiotic Degradation: Hydrolysis as a Function of pH”, L383 A, December 1992.

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
None

Radiolabelling:

not specified

Analytical monitoring:

not specified

Details on sampling:

See below

Buffers:

Buffer pH 4, Biphthalate Baker Art. No. 5657
Buffer pH 7, Phosphate Baker Art. No. 5656
Buffer pH 9, Borate Baker Art. No. 7145
The buffer solutions were sterilized for 25 minutes in an autoclave prior to first use. Nitrogen was passed through the buffer solutions for 2 minutes except when freshly sterilized.

Details on test conditions:

According to the OECD guidelines. However due to the very low solubility of the FP-100 the test was not completed

Number of replicates:

N/A

Statistical methods:

see report

Preliminary study:

See report

Test performance:

The solubility of FP-100 in the buffer solutions pH 4.0, pH 7.0 and pH 9.0 was very low. It was not possible to increase the solubihty of the test item with the use of different solubilizers (acetonitrile, dimethylsulfoxide and tetrahydrofuran). 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 with FP-100 at pH 4.0, pH 7.0 and pH 9.0.

The r2 fit was 0.9999 (optimum = 1.0000). This reflects the linearity of the HPLC-system within the calibration range of 0.948 µg/mI to 113.76 µg/mI of the test item.

Transformation products:

not measured

Remarks on result:

not determinable

Other kinetic parameters:

N/A

Details on results:

N/A

Validity criteria fulfilled:

yes

Remarks:

Solubility too low for test to be completed

Conclusions:

Hydrolysis of FP-100 could not be determined due to its poor water solubility

Description of key information

FP-100 is poorly water soluble and its hydrolysis could not be determined

Key value for chemical safety assessment

Half-life for hydrolysis:

1 yr

at the temperature of:

20 °C

Additional information

Hydrolysis of FP-100 could not be determined due to its poor water solubility