Registration Dossier

Ecotoxicological information

Toxicity to terrestrial plants

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

The chemical safety assessment according to Annex I of Regulation (EC) No. 1907/2006 does not indicate the need to investigate further the toxicity to terrestrial plants.

Key value for chemical safety assessment

Additional information

Experimental data on the toxicity of Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS 68604-38-6) to terrestrial plants are not available. In accordance with Regulation (EC) No. 1907/2006, Annex IX, column 2, 9.4 studies on terrestrial organisms do not need to be conducted when there is no risk indicated by the chemical safety assessment.

Based on the available experimental toxicity data the substance is expected to be not toxic to soil organisms. The substance is expected to be largely physically removed in sewage treatment plants and thus a transfer to the terrestrial environment is not likely. If transferred to the soil an adsorption to soil particles is probable as indicated by the high log Koc (C16 FA component: 2.27, C18 unsat. FA component: 46.87, C18 FA component: 48.16; KOWWIN v1.68; Blum, 2011). Furthermore the substance has a low water solubility (< 0.15 mg/L, Frischmann, 2012) indicating that its concentrations in soil pore water are negligible. Thus, the substance is presumably not available for plants in the soil. An uptake of the substance by plant roots is also hindered by the high molecular weight of the substance (1684 – 1853 g/mol) preventing the substance from crossing biological membranes. However, acute or chronic toxicity of the substance to terrestrial organisms is generally not expected. The lack of chronic toxicity of the substance was demonstrated by a study chronic toxicity on Eisenia fetida (OECD 222). Neither mortality nor an effect on earthworm reproduction was observed (NOEC ≥ 1000 mg/kg soil dw).
In conclusion, the substance is unlikely to pose a risk for terrestrial plants based on a) the lack of exposure and b) the low toxicity as expected for this substance for the terrestrial compartment based on the available experimental data, metabolism considerations and the lack of adverse effects in aquatic ecotoxicity tests.
In accordance with Regulation (EC) No. 1907/2006, Annex X, Column 2, 9.4 further studies on the effects on terrestrial organisms do not have to be conducted since the chemical safety assessment indicates that toxicity to terrestrial plants is not expected to be of concern.