Tetra-esterification products of C5-(branched and linear), C7, C8 and C10 fatty acids with pentaerythritol

Toxicity to terrestrial plants

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.

Additional information

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 there is no need. No experimental data on toxicity to terrestrial plants are available for the members of the PE esters group. Generally, all members show high adsorption potential (log Koc 3.3 – 30.23). Exposure of plants to these substances is expected to be very limited, since they are not expected to be found in the pore water in significant quantities, due to poor water solubility and high adsorption potential.

In absence of a clear indication of selective toxicity towards a specific group of organisms, terrestrial toxicity of PE esters was tested on the earthworm Eisenia fetida, as recommended by the “Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance” (ECHA, 2012).The study was conducted with the group member2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate(CAS 25151-96-6). This substance did not show any mortality or effects on reproduction of earthworms in a chronic test according to OECD 222 up to 1000 mg/kg dw soil.

Testing according to OECD 207 with the group member decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS No. 71010-76-9) is still ongoing. In addition, the results of tests according to OECD 222 with two group members (fatty acids, C16-18 and C18-unsaturated, esters with pentaerythritol(CAS 85711-45-1) andfatty acids, C16-18 and C18-unsatd., tetraesters with pentaerythritol(CAS 68604-44-4) are also not yet available. It is not expected that the results from the new studies will lie out of the overall ecotoxicological profile of the group. The dossier will be updated as soon as possible and the Chemical Safety Assessment according to Annex I of Regulation (EC) No 1907/2006 will be re-evaluated based on the outcome of this new study.

Based on the above mentioned available data, the terrestrial toxicity of the members of the PE esters group are expected to be very low. Additionally, the members are not expected to remain in the terrestrial environment, due to ready biodegradation. A relevant uptake and bioaccumulation in aquatic organisms is not expected due to the low water solubility, rapid environmental biodegradation and metabolisation via enzymatic hydrolysis. Enzymatic breakdown will initially lead to the free fatty acid and the free alcohol (e. g. pentaerythritol). This is supported by a low calculated BCF value of 0.89 – 24.7 L/kg ww (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic) of the members of the PE esters group. Since the hydrolysis products are supposed to be satisfactory metabolized in organisms, no potential for bioaccumulation is to be expected. For more information on the metabolism of enzymatic hydrolysis products please refer to IUCLID section 5.3, 6.3 or Chapter 4.3 Bioaccumulation.

In conclusion, the PE esters group members are 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.