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Description of key information

One reliable key study is available on the registered mixture investigating the hydrolysis of its two main constituents: the monoester and the diester. As less than 10 percent of the constituents is observed to hydrolyse after 5 days at 50°C and pH 4, 7 and 9 ( Tier 1), the substance is considered to be stable to hydrolysis with an half-life > 1 year.

Key value for chemical safety assessment

Half-life for hydrolysis:
1 yr
at the temperature of:
25 °C

Additional information

The determination of hydrolysis was carried out on the registered mixture according to Method C7 Abiotic Degradation, Hydrolysis as a Function of pH of Commission Regulation (EC) No 440/2008 of 30 May 2008 and the OECD Guideline 111 for Testing of Chemicals, 13 April 2004 and is GLP compliant. No deviation from the guidelines were observed during the test.

The test system uses sterile buffer solutions at pH 4.0, 7.0 and 9.0. The test item was dissolved in an aqueous solution at a specific pH value (4.0, 7.0 and 9.0) and was incubated in the dark and at a specific temperature, in a water bath thermostated at 50 ± 0.5 °C.

The concentration of the two main constituents of the test item, the monoester and the diester, was determined as a function of time, using a HPLC-MS method. Calculations were performed individually for the monoester and the diester component peaks of the test item.

On initial undertaking of the preliminary test, analytical results from the pH 4 and pH 7 samples were inconclusive. The preliminary test was repeated using an adapted procedure designed to minimize the potential for excessive influence from experimental variance and an additional test was performed at pH 4 using a citrate buffer system, to attempt to eliminate the influence of the matrix peak observed from the original pH 4 phthalate buffer composition.After 5 days at 50°C , less than 10% hydrolysis were measured for both the monoester and the diester at pH 4 (in phtalate and citrate buffers), 7 and 9.

The estimated half-life at 25 °C of the test item for pH 4, 7 and 9 has been shown to be greater than 1 year (Tier1 assessment).