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

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Data waiving:

study technically not feasible

Justification for data waiving:

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
[Specific explanation in addition to field 'Justification for data waiving']
As stated and explained in the endpoint Water Solubility (4.8), no robust and reliable analytical validation method in aqueos solutions could be established. Additionally, pre-testing with nominal limit concentrations showed no biological effect in fish.

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

water solubility

Data waiving:

study technically not feasible

Justification for data waiving:

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
Pre-tests for the determination of the water solubility with shake flask method showed insufficient phase separation using centrifugation. Because the test item was distributed in the test item/water mixtures in all layers the slow stirring method cannot be applied too. The filtrated test item/water mixture did not show an evaluable test item signal. This may be due to adsorption effects of test item at the filter.
Column elution method should be used for essentially pure substances only, and the purity of the test item is not sufficient for this method. Nevertheless, this test was performed, but did not show an evaluable test item signal too.
Water solubility of the test item lay < 40 µg/L during these tests therefore (the proposed LOQ of 20 µg/L dilution by sample preparation were taken into account).
Because the test item was not dissolvable in solvents which are not miscible with water, the extraction of eluates was not possible.
Because of the low solubility of the test item in aqueous medium and in further solvents, usable for extractions, no analytical method for the determination of N-(hydroxymethyl) stearamide could be found for the determination of test item in aqueous solutions.