Registration Dossier
Registration Dossier
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EC number: 288-305-7 | CAS number: 85711-45-1
Toxicity to terrestrial plants
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
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 earthworms, Eisenia fetida or Eisenia andrei, as recommended by the “Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance” (ECHA, 2012). Chronic tests were conducted with 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) according to OECD 222 under GLP conditions. These substances did not show any mortality or effects on reproduction of earthworms 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) resulted in no effects on mortality in the treatment group exposed to 1000 mg/kg dw soil.
Based on the above mentioned available data, the terrestrial toxicity of the members of the PE esters group is 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.
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