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Short-term toxicity to aquatic invertebrates

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One reliable study is available. In this study Daphnia magna were exposed to a Water Accommodated Fraction of an analogue substance (EC 613 -848 -7) at a nominal loading rate of 100 mg/L under static conditions for 48 hours. The EL50(48 h) value was > 100 mg/L loading rate WAF. The substance is not acutely harmful to aquatic invertebrates.

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One reliable study is available. In this study (Harris, 2013) performed under GLP according to OECD TG 202 and EC Method C.2, Daphnia magna were exposed to the analogue substance under static conditions for 48 hours at a temperature of 22 °C to 25 °C. Due to the low aqueous solubility and complex nature of the test item, the test medium was prepared as a Water Accommodated Fraction (WAF). Following a preliminary range-finding test, twenty daphnids ( 4 replicates of 5 animals) were exposed to a WAF of the test material at a nominal loading rate of 100 mg/L. The number of immobilized Daphnia and any adverse reaction to exposure were recorded after 24 and 48 hours. The EL50 (48 h) value was > 100 mg/L loading rate WAF.

The results of this study are supported by data available for read-across substances fatty acid polyols (Fatty acids, C5-9, esters with pentaerythritol (EC 270-290-3, CAS 68424-30-6) and Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (EC 234-392-1, CAS 11138-60-6)). The substance with the CAS No. 131459-39-7 is a structural analogue of one of the read-across substances (CAS No. 68424-30-6) and can be used for read-across also.

The justification for read-across is presented in Section 13 Assessment reports- Read-across justification.

Four studies, investigating the short-term toxicity to aquatic invertebrates of Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS-No. 11138-60-6), were available. These studies were conducted with Daphnia magna and according to OECD 202. All measured results from 48 -hour toxicity studies indicate the test substance is of low toxicity to Daphnia magna.

Häner (2007) determined EL 50 (48h) > 100 mg/L (WAF loading rate) and Kuttler (1998) observed no immobilisation at 10000 mg/L (EL50 > 10000 mg/L, WAF loading rate). Both other studies (Källquist 1995 and Craig 2005) calculated EL50 > 1000 mg/L (WAF loading rate) with an immobilisation under 50% at 1000 mg/L (Källquist: 32%; Craig: 45%). In addition, a 15-day reproduction test (Low, 1996, entered in 6.1.4) showed no immobile daphnia during the whole test duration at a WAF loading rate of 2570 mg/L. One other available test result (EC50 = 15.86 mg/L) should be evaluated with caution because the original report was not available and therefore the documentation was insufficient for assessment (Draguez, 1991). Nonetheless, all data show toxicities of Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS-No. 11138-60-6) far in excess of natural occurring concentrations (water solubility < 0.3 mg/L). Therefore, the substance is not harmful to aquatic invertebrates.

In an addition study on 3,5,5-trimethylhexanoic acid mixed tetraesters with PE and valeric acid (CAS-No. 131459-39-7). In this GLP-study withDaphnia magnaaccording to OECD 202 (1984) no effect on immobilisation was observed at the tested WAF loading rates (Sewell and McKenzie, 2003). The observed EL50 (48h) > 1000 mg/L with a NOELR ≥ 1000 mg/L. Chemical analysis of the WAF loading rates at 0 and 48 h showed measured test concentrations less than or at the limit of quantification of the analytical method (< 0.032 mg/L).