Reaction mass of N,N-ethanediylbis- Hexadecanamide, N-[2-[(1-oxohexadecyl)amino]ethyl]-Octadecanamide, Hexadecanoic acid, 12-hydroxystearic acid, reaction products with ethylenediamine, N,N-ethanediylbis-Octadecanamide and Octadecanoic acid, 12-hydroxystearic acid, reaction products with ethylenediamine

Endpoint summary

Description of key information

Licolub FA 6

 

Toxicokinetics

There are no studies available in which the toxicokinetic properties of the substance were investigated.

 

The test item consists of slightly yellow granules. The water solubility is < 0.001 g/L (see IUCLID chapter 4.8). The octanol water partition coefficient (Log P_ow) for the substance was determined to be 3.9 (see IUCLID chapter 4.7). Due to the water insolubility a general potential of bioaccumulation can be excluded.

 

Absorption

With reference to the insolubility in water and its complex structure the absorption of the substance is considered to be restricted (please refer to ECHA Guidance on information requirements and chemical assessment, Chapter R.7c, Table R.7.12-1, p. 168). Furthermore, even if low amounts of the substance are dissolved in aqueous solutions it might dissociate into ionic species (i.e. N⁺). Ionisation does not contribute to a readily diffusion across biological membranes (please refer to ECHA Guidance on information requirements and chemical assessment, Chapter R.7c, p. 167). Therefore, an excessive absorption of the substance can be excluded. This assumption is strengthened by the results of several toxicity studies in rats (acute oral toxicity study: LD₅₀> 2000 mg/kg bw; 14 day DRF: NOEL 1000 mg/kg bw/d (no adverse changes observed in all dose groups)).

 

Distribution

The substance is not water soluble. Therefore, it will not migrate into cells and concentrate in adipose tissues or other systemic compartments (please refer to ECHA Guidance on information requirements and chemical assessment, Chapter R.7c, pp. 176-177).

 

Metabolism

Taking into account the water insolubility and the results of several oral toxicity studies, an uptake of considerable amounts of this substance is not considered to occur. However, absorption of marginal amounts can not be excluded.

Studies on genotoxicity performed with the test item and its structural analogue (Ames-Test; MLA and chromosome aberration study) were negative, i.e. there is no indication of a reactivity of the substance under the test conditions.

 

Excretion

With reference to the limited solubility the biliary excretion might be considered as the most favorable excretion route. Therefore, enterohepatic recycling resulting in a prolonged biological half-life can not be excluded (please refer to ECHA Guidance on information requirements and chemical assessment, Chapter R.7c, p. 178).