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EC number: 292-947-3 | CAS number: 91031-45-7
Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
Description of key information
LC50 (14 d) > 1000 mg/kg dw for Eisenia fetida (OECD 207/EU Method C.8)
Key value for chemical safety assessment
Additional information
Since no studies investigating the toxicity to soil macroorganisms of fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters (3EO) (CAS 91031-45-7) are available for this endpoint, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to the two 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) was conducted. This read-across is justified in detail in the analogue justification in IUCLID Section 13. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substance was used for the assessment. Nevertheless, as it can be seen in the data matrix of the analogue justification in section 13 and the overall summary, all reliable data from the source substances support the hazard assessment by showing a consistent pattern of results.Testing of the toxicity on earthworm evaluates the exposure to the test substance via soil pore water, surface contact as well as by ingestion of soil particles. A long-term test is considered not be relevant as the results of the chemical safety assessment according to Annex I of Regulation (EC) No 1907/2006 did not indicate the need to investigate further effects of the substance on terrestrial organisms. The substance has been shown to be readily biodegradable and therefore does not have a potential for persistence and thus no indirect chronic exposure of the soil. Additionally, no toxicity was observed in the standard acute toxicity tests to aquatic organisms on the three trophic levels (fish,daphnia, algae). Since indirect exposure is ruled out due to the ready biodegradability of the substance, only direct exposure could pose a risk. A higher solubility would imply that if exposure were to occur this substance would not only be adsorbed to soil particles (log Koc >5) but also concentrations may exist within the soil pore water also. The smaller fatty acid chain length increases the water solubility and therefore the bioavailability in the pore water. Water solubility is negatively correlated with the C-chain length of the fatty alcohol and fatty acid (Lide, 2005). Therefore, it is possible to extrapolate from a read-across substance with higher water solubility since it has an increased bioavailability in the pore water and can therefore be seen as a worst case for absorption via pore water (ECHA, 2012).
The first study with butylene glycol dicaprylate / dicaprate was performed according to OECD 207 under GLP conditions (Lührs, 2001). Eisenia fetida was exposed to 5 different test substance concentrations up to 1000 mg/kg dw in artificial soil for 14 d. Mortality and body weight were recorded at the end of the study. No mortality was observed resulting in a LC50 of > 1000 mg/kg dw. The body weight increased significantly at a test concentration of 1000 mg/kg dw. Therefore, a NOEC of 500 mg/kg dw was determined.
Eisenia foetida foetida was used in the second study according to EU Method C.8 (GLP) to evaluate the toxicity of decanoic acid, mixed diesters with octanoic acid and propylene glycol to soil macroorganisms (Scholz, 1996). A limit test with a concentration of 1000 mg/kg dw did not result in mortality after 14 d of exposure. Therefore, a LC50 > 1000 mg/kg dw was determined.
Based on the results from a structurally related read-across substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by an equal ecotoxicological profile, it can be concluded that fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters (3EO) will not exhibit effects on soil macroorganisms.
References
ECHA (2012): Guidance on information requirements and chemical safety assessment, Chapter R.7b: Endpoint specific guidance.
Lide, D.R., Ed. (2005): CRC Handbook of Chemistry and Physics. 86th Edition, CRC Press Taylor & Francis Group, Boca Raton, USA.
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