Reaction mass of N-(hydroxymethyl)hexadecan-1-amide and N-(hydroxymethyl)stearamide

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

Data waiving:

study technically not feasible

Justification for data waiving:

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING

Exemplarily for the matrices solubility tests were performed with demineralized water, because usually solubility is higher in demineralized water then in other matrices, due to the higher salt content of other matrices. The pH value of the matrices is not expected to show an effect on the solubility of the test item, because the test item is estimated to be unionized ≥ 95 % at pH 0.3 – 12.4 (estimated using software ACD/Labs I-Lab 2.0).

Determination via Shake Flask Method
A test item/water mixture with nominal concentration 100 mg/L was prepared and shaken for 11 days at room temperature on an orbital shaker with 200 rpm. The mixture showed test item particles overall in the mixture, which could not be separated by centrifugation with 3000 resp. 4000 rpm. The mixture was filtrated using PTFE filters 0.45 µm pore size and measured with LC-MS-MS. No signal was detected at the retention time of the test item. Because adsorption of the test item at the PTFE filter was assumed a further pre-test was performed.

Determination via Column Elution Method
Column elution method should be used for essentially pure substances only, and the purity of the test item is not sufficient for this method. Never-theless this test was performed, because adsorption of the test item at PTFE filters as used in chapter 3.2.1 was assumed.
5 g quartz sand was thoroughly mixed with 1 g N-(hydroxymethyl) stearamide. The mixture was filled into the column, which was closed at the lower end. Then, the column was also closed at the upper end.
Using the HPLC pump, a flow of demineralized water of 25 mL/hour was adjusted and the first column volumes were discarded (pre-run over night). Temperature was 20.0 °C. After that, two fractions with about 10 mL were collected for analysis. No signal was detected at the retention time of the test item.

Description of key information

As no validated method for determination of the substance in water could be established, no study on hydrolysis could be performed. In general, the substance is expected to be hydrolysed to the carboxylic acids, ammonium hydroxide and formaldehyde.