Registration Dossier
Registration Dossier
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EC number: 292-947-3 | CAS number: 91031-45-7
Toxicity to terrestrial arthropods
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 arthropods.
Key value for chemical safety assessment
Additional information
In accordance with Regulation (EC) No. 1907/2006, Annex IX, 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 fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters (3EO) (CAS 91031-45-7). The test substance is characterised by a high log Koc indication a considerable potential for adsorption to the soil particles. Therefore, tests with soil-dwelling organisms that feed on soil particles are most relevant for the evaluation of soil toxicity of ethylene distearate.
Read-across in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 from structurally related analogue substances butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) and decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) did not show any mortality to earthworms in acute tests according to OECD 207 and EU Method C.8, respectively (LC50 > 1000 mg/kg soil dw). A plant study with butylene glycol dicaprylate / dicaprate according to OECD 208 with three species from different taxonomic groups resulted in an EC50 of > 100 mg/kg soil for all tested species.
Moreover, the read-across substance butylene glycol dicaprylate / dicaprate did not show any chronic effects up to the limit of water solubility on the water flea Daphnia magna in a study according to OECD 211.
Since the substance is readily biodegradable, a chronic exposure of terrestrial organisms is not likely. Thus, acute tests with terrestrial organisms from different taxonomic groups in combination with chronic aquatic data indicating no effects up to the limit of water solubility are sufficient to assess the toxicity to terrestrial organisms.
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