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Experimental data investigating the terrestrial toxicity of 2,2-bis[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 25811-35-2) are not available. Therefore the assessment was based on data from the source substances decanoic acid, mixed esters with 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). The short term toxicity study following OECD 207 conducted with decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS No. 71010-76-9) determined no effects on earthworm survival (NOEC (14 d) ≥ 1000 mg/kg dw). Comparable results were obtained in two long-term studies conducted with the source substances 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) according to OECD 222. No effects on survival or reproduction of the earthworms were observed (NOEC (56 d) ≥ 1000 mg/kg dw). Thus the toxicity of the target substance 2,2-bis[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 25811-35-2) to terrestrial arthropods is expected to be low. The target and source substances are generally characterised by a high adsorption potential (log Koc > 3) and low water solubility (WS <1 mg/L). However, an accumulation in soil is not expected. The substances are expecte to be extensively removed in sewage treatment plants. Tthe 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. The high log koc and low water solublity indicate furthermore that an uptake of the substances via plant roots is unlikely. Acute and chronic tests conducted with the source substances 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. Additionally, the target and source substances are not expected to persist 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 low calculated BCF values of 0.89 – 24.7 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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