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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.

Key value for chemical safety assessment

Additional information

Experimental data on the toxicity of Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS 68604-38-6) to terrestrial arthropods are not available. In accordance with Regulation (EC) No. 1907/2006, Annex IX, column 2, 9.4 studies on terrestrial organisms do not need to be conducted when there is no risk indicated by the chemical safety assessment.
Based on the available experimental toxicity data the substance is expected to be not toxic to soil organisms. The substance is expected to be largely physically removed in sewage treatment plants and thus a transfer to the terrestrial environment is not likely (according to the Guidance on information requirements and chemical safety assessment, Chapter R.7b (ECHA, 2012)). If transferred to the soil an adsorption to soil particles is probable as indicated by the high log Koc (C16 FA component: 2.27, C18 unsat. FA component: 46.87, C18 FA component: 48.16; KOWWIN v1.68; Blum, 2011). Therefore the substance might be ingested by soil-dwelling organism feeding on soil particles. When ingested by soil dwelling organisms, the substance is expected to be metabolised and thus an accumulation and/or chronic effects are not likely. The lack of chronic toxicity was demonstrated by a chronic toxicity test on Eisenia fetida (OECD 222). Neither mortality nor an effect on earthworm reproduction was observed (NOEC reproduction/mortality: 1000 mg/kg soil dw).
Moreover, a chronic toxicity test with aquatic invertebrates is conducted with Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS 68604-38-6). The substance did not show any chronic effects up to the highest tested concentration of 100 mg/L on the water flea Daphnia magna in a GLP study according to OECD 211.
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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