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Experimental data on the aquatic toxicity of Reaction mass of bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl] adipate and [2-[2-(2-butoxyethoxy)ethoxy]ethyl](3,6,9,12-tetraoxahexadecyl)adipate (EC 943-330-9) are available for aquatic invertebrates and algae. In the study on the acute toxicity of the substance toDaphnia magnano adverse effects were determined (EC50 (48 h) > 100 mg/L, nominal). The algal growth was inhibited by the test substance and an ErC50 > 91 mg/L (measured, geom. mean) and a NOErC of 7 mg/L (measured, geom. mean) were determined.

The assessment of the acute toxicity to fish and the toxicity to microorganisms is based on a read-across approach. In accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across to the structurally related substances bis(2-(2-butoxyethoxy)ethyl) adipate (CAS 141-17-3) and bis(2-ethylhexyl) adipate (CAS 103-23-1)was conducted to fulfill the information requirements for acute toxicity to fish and toxicity to microorganisms.In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for aquatic toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across). According to Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 substances can be considered similar if their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.

The target substance, a multi-constituent, and the mono-constituent source substances consist of diesters of adipic acid. The alcohol moieties of the target substance and the source bis(2-(2-butoxyethoxy)ethyl) adipate are ethoxylated. The alcohol of the source substance bis(2-ethylhexyl) adipate is not ethoxylated.

The target and the source substance bis(2-(2-butoxyethoxy)ethyl) adipate are characterised by a relatively high water solubility (WS> 0.5 g/Lat 20 °C), low vapour pressure (<0.0001 Pa at 20 °C)and low log Koc values (log Koc <3). Thus, the substances are expected to have a similar environmental fate and ecotoxicity profile. The source substance bis(2-ethylhexyl) adipate is characterised by a lower water solubility (WS: 0.78 mg/L at 22°C) and a higher adsorption potential as the target substance (log Koc: 5.28). The substance characteristics are slightly different from the physico-chemical properties of the target substance. The read across was nevertheless considered suitable for the prediction of the toxicity to microorganisms as both, target and the source substance, are readily biodegradable. Furthermore the risk assessment for the target substance predicted very low exposure concentrations and thus a risk for STP microorganisms is considered unlikey (Local PEC STP < 0.001 mg/L). A detailed justification of the Analogue Approach is attached in IUCLID section 13.

The available data on the toxicity to microorganisms of the source substance Bis(2-ethylhexyl) adipate (CAS 103-23-1)determined no adverse effects on micororganisms.

In the available acute toxicity study to fish performed with the source substance Bis[2-(2-butoxyethoxy)ethyl] adipate (CAS 141-17-3) lethal and sublethal effects (i.e. loss of equilibrium) were observed. After 96 h of exposure aLC50 (96 h) of 13 mg/L was determined. The determined effect concentrations do not lead to a classication of the substance, however due to the observed effects a PNEC was derived and an environmental exposure caluculation was performed.