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Toxicity to terrestrial arthropods

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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 arthropods.

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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 arthropods.

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 arthropods are available for the members of the PE esters group. Generally, all members show high adsorption potential (log Koc 3.25 – 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).

Five studies (according to OECD 222, 207 and 216) are available for four PE group members. Chronic toxicity studies conducted under GLP according to OECD 222 with earthworms exposed to the group members fatty acids, C16-18 and C18-unsaturated, esters with pentaerythritol (CAS 85711-45-1), 2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6) and fatty acids, C16-18 and C18-unsatd., tetraesters with pentaerythritol (CAS 68604-44-4) resulted in no effects on mortality and reproduction up to a concentration of 1000 mg/kg dw soil in all three chronic toxicity studies. Additionally, in an acute test according to OECD 207 with decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS No. 71010-76-9) no mortality occurred in both the control and treatment group resulting in a NOEC (14 d) ≥ 1000 mg/kg dw soil. These four substances represent both ends of the group and the results are used to cover other polyol esters by interpolation. The category member decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) belongs to the lower end of the category (C5-C10 fatty acid chain length) and is assumed to represent worst case in terms of absorption via pore water as explained above. The long-term studies with fatty acids, C16-18 and C18-unsaturated, esters with pentaerythritol (CAS 85711-45-1), 2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6) and fatty acids, C16-18 and C18-unsatd., tetraesters with pentaerythritol (CAS 68604-44-4) strengthen the read-across approach for esters with fatty alcohol chain lengths of C16-18 and C18 unsaturated. The toxicity to soil micro-organisms with 2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6) was tested in a GLP study according to OECD 216. The EC50 for the nitrogen transformation was calculated to be > 1000 mg/kg dw soil (the highest concentration tested). Available data for toxicity to aquatic microorganisms for the PE ester group members confirms the determination of a lack of toxicity to soil microorganisms. No inhibition of respiration rate of aquatic microorganisms was observed in any of the available studies for the PE esters group members. 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 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 arthropods is not expected to be of concern.