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Short-term toxicity to aquatic invertebrates

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Description of key information

No toxic effects to aquatic invertebrates up to the limit of water solubility (< 0.15 mg/L).

Key value for chemical safety assessment

Additional information

In accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to three structurally related category membersdecanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid(CAS 71010-76-9),decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate(CAS 11138-60-6) andfatty acids, C8-10 mixed esters withdipenaterythritol, isooctanoic acid, pentaerythritol and tripentaerythritol (CAS 189200-42-8) was conducted to fulfill the data requirements according to Annex IX of fatty acids, C8-10, tetraesters with pentaerythritol (CAS 85586-24-9) in regard to toxicity to aquatic invertebrates. This read-across is justified in detail in the overall summary (IUCLID chapter 6.1) and within the category 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 substances were used for the assessment. The fatty acid chain lengths of C5-C10 of the read-across substances are in a similar range to those of the target substance.

The first reliable GLP study was conducted with the read-across substance decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS No. 71010-76-9) according to OECD 202, under static conditions usingDaphnia magnaas test organism (Blattenberger, 2006). The WAFs were prepared by adding the appropriate amount of test substance with subsequent stirring and sampling of the aqueous portions through the outlet at the bottom of the vessels. Loading rate WAFs of 62, 132, 251, 503 and 1072 mg/L were tested. No immobilisation was observed in any treatment and the control throughout the test period of 48 h. Hence, the 48 h-EL50 is determined to be > 1072 mg/L based on the nominal test concentration.

Furthermore, one key and three supporting studies investigating the short-term toxicity to aquatic invertebrates are available for the read-across substancedecanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate(CAS 11138-60-6). The most recent and reliable study was performed under static conditions according to OECD 202 (Häner, 2007).Daphnia magnawas exposed to a nominal concentration of 100 mg/L (prepared as water accommodated fraction, WAF). A 48 hour-LC50 of > 100 mg/L was determined and is hence above the limit of water solubility (< 0.3 mg/L). The result of this key study is confirmed by three supporting studies conducted according to OECD 202 (Kuttler, 1998; Källqvist. 1995; Craig, 2005). In all studies no effects up to the water solubility of the test substance (< 0.3 mg/L) occurred.

For the third read-across substancefatty acids, C8-10 mixed esters with dipenaterythritol, isooctanoic acid, pentaerythritol and tripentaerythritol(CAS 189200-42-8) one short-term toxicity test with daphnids according to OECD 202 is available (Febbo, 1995). The GLP study was conducted under static conditions using Daphnia magna as test organisms. Individual test solutions were prepared as WAF (nominal test concentrations of 62.5, 125, 250, 500 and 1000 mg/L). No effects were observed up to the highest test concentration resulting in an EL50 of > 1000 mg/L.

Based on these results from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile, it can be concluded thatfatty acids, C8-10, tetraesters with pentaerythritol (CAS 85586-24-9)will not exhibit short-term effects to aquatic invertebrates up to the limit of water solubility.As it can be seen in the data matrix of the category justification in section 13 and the overall endpoint summary IUCLID 6.1, all reliable data in the polyol esters category support this hazard assessment by showing a consistent pattern of results, i.e. no toxic effects were observed to aquatic invertebrates or other aquatic organisms up to the limit of water solubility.

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