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Description of key information

Determination of the Abiotic Degradation of FAT 40858/A TE (Hydrolysis as a Function of pH)

Key value for chemical safety assessment

Additional information

In a preliminary test the test item was dissolved in aqueous solutions buffered at pH 4, 7 and 9 and incubated at 50 ± 0.5 °C for maximum of 5 days.

No significant reduction of the test item concentration was observed in the samples incubated at pH 4.

In the incubated samples at pH 7 a significant reduction of the test item concentration was observed.

In the incubated samples at pH 9 the test item degraded rapidly. No test item related signal could be found in the freshly prepared samples.

A main test was performed to determine the half-life time of FAT 40858/A TE at pH 7. No main test was performed at pH 4 and pH 9.

Amain test was performed in buffered solutions at pH 7. The test item was dissolved and incubated at 23°C, 40 °C and 50 °C.The concentration of the test item was determined as a function of time. The logarithms of the concentration relation (co/ct) were plotted against the time. A pseudo first order reaction was assumed. The correlation coefficients were calculated and the reaction constants and half lifes were calculated from regression data at each temperature.

For reaction at pH 7 the Arrhenius relationship was calculated based on data generated at 23, 40 and 50 °C. Logarithm of the rate constants were plotted against the reciprocal of the absolute temperature.
Following relation was found:

pH 7: ln k = - 11866 * 1/T + 36

Degradation Products: The UV-chromatograms showed several degradation products as signal eluting prior to the test item signal. In agreement with the sponsor, no identification of the metabolites was performed.


The test item is stable at pH 4.

At pH 7, the test item is degraded by hydrolysis. The half life of reaction at 23 °C was determined to be 23 h at pH 7.

At pH 9 the test item is supposed to degrade immediately.