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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 as the chemical safety assessment indicates no need for further testing. Experimental data on the toxicity of 2,2-bis[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 25811-35-2) to terrestrial arthropods is not available. Though the substance is characterised by a high adsorption potential (log Koc > 5) an accumulation in soil is not expected. Thus, a rapid and extensive removal of the substance in sewage treatment plants can be expected. Furthermore the Guidance on information requirements and chemical safety assessment, Chapter R7.b (ECHA, 2012) states that once insoluble chemicals enter a standard STP, they will be extensively removed in the primary settling tank and fat trap and thus, only limited amounts will get in contact with activated sludge organisms. Due to the high log Koc a significant degree of removal of these substances from the water column due to adsorption can be expected (Guidance on information requirements and chemical safety assessment, Chapter R.7a (ECHA, 2012)). Consequently a significant release to the environment of the substance via STP effluents is not expected and thus an exposure of terrestrial organisms is unlikely. However, acute and chronic tests conducted with structurally analogue substances decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9), fatty acids, C16-18 and C18-unsatd., tetraesters with pentaerythritol (CAS 68604-44-4) and fatty acids, C16-18 and C18-unsaturated, esters with pentaerythritol (CAS 85711-45-1) on Eisenia fetida indicate that an acute or chronic toxicity of the substance is unlikely. The substances caused neither mortality nor a decrease in the reproduction rate of adult earthworms and thus a NOECmort/repro of ≥ 1000 mg/kg was reported for the read across substances. Additionally, the test substance is 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 0.895 L/kg ww (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic). 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.

 

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