Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Additional information

The substance “condensation products of tall-oil fatty acids with diethanolamine and triethanolamine” is a UVCB-substance having variable composition. Therefore, it is not possible to analytically quantify the substance in environmental systems like water, sediment, soil. Accordingly, it also is not possible to experimentally determine absence or presence of a bioaccumulation potential. However, based on the chemical composition, the physical-chemical properties, and the very low toxicological potential as observed in all toxicological and eco-toxicological tests it is very likely that the substance does not have a bioaccumulation potential.

This conclusion is developed in the endpoint summary of Chapter 7.1 “Toxicokinetics” (Section 5.1 of the CSR):

“Based on all available information no final conclusion on a bioaccumulation potential can be drawn. However, based on the physico-chemical properties, the chemical composition and the very low toxicological potential observed in the animal tests the following fate in the animal body is very likely:

1) in an aqueous environment WS400128 forms micelles and thus it may not be available (or only to a small part) for absorption in the digestive tract;

2) the fatty acid esters may be hydrolysed in the digestive tract by digestive enzymes;

3) fatty acid esters that may be absorbed in the digestive tract may be hydrolysed by esterases in the liver (and blood).

The products of hydrolysis, e.g. mono- and diesters of triethanolamine and free fatty acids, are more hydrophilic and thus do not have an accumulation potential.

 

Therefore, it is rather likely that WS400128 will not bioaccumulate because it is not absorbed in the digestive tract and directly excreted as such and/or it is (partially) hydrolysed to more hydrophilic substances not having an accumulation potential.”