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Short-term toxicity to fish

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Description of key information

No toxic effects to fish 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 members decanoic acid, mixed esters with octanoic acid and pentaerythritol (CAS 68441-68-9), decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS No. 71010-76-9) andfatty acids, C8-10 mixed esters with dipenaterythritol, isooctanoic acid, pentaerythritol and tripentaerythritol(CAS 189200-42-8) was conducted to fulfill the data requirements according to Annex VII-IX of fatty acids, C8-10, tetraesters with pentaerythritol (CAS 85586-24-9) in regard to short term toxicity to fish. 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 the same range of those of the target substance. In addition, the read-across substances contain the same alcohol component, i.e. pentaerythritol, and are tetra-esters.

The first short term study with the read-across substance decanoic acid, mixed esters with octanoic acid and pentaerythritol (CAS 68441-68-9) was performed under semi-static conditions according to ISO 7346-1 (Gode & Richterich, 2008).Brachydanio rerio(new name Danio rerio) was exposed to nominal concentrations of 1000 mg/L, 3000 mg/L and 10000 mg/L. The test substance was weighed directly into the test vessels, filled up with standard dilution water and stirred. An LC50 of > 3000 - < 10000 mg/L was determined and is hence above the limit of water solubility.

The second study with the read-across substance decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS No. 71010-76-9 was conducted under static conditions according to OECD 203 usingBrachydanio rerioas test organism (Lili, 2009). Nominal test concentrations of 100 and 150 mg/L were applied. Test substance monitoring using TOC analysis measured test concentrations of 0.696 and 0.704 mg/L, respectively. Undissolved test material was not removed from the test system; however, this is considered negligible, because no mortality was observed in any treatment and the control throughout the test period of 96 h. Hence, the 96 h-LC50 is determined to be > 0.704 mg/L (arithmetic mean) and thus above the limit of water solubility.

The third study with the read-across substancefatty acids, C8-10 mixed esters with dipenaterythritol, isooctanoic acid, pentaerythritol and tripentaerythritol(CAS 189200-42-8) was conducted under semi-static conditions according to EPA OTS 797.1400 (fish acute toxicity test, adopted in 1987) and GLP using Pimephales promelas as test organism (Targia, 1994). Water Accommodated Fractions (WAFs) were prepared. Nominal test concentrations of 0.312 mg/L, 0.625 mg/L, 1.25 mg/L, 2.5 mg/L and 5.0 mg/L were applied. GC analysis resulted in test concentrations of 0.241 mg/L, 0.847 mg/L, 1.30 mg/L, 2.15 mg/L and 4.11 mg/L, respectively. Methods development data suggest that 5 mg/L is the maximum achievable water soluble concentration of the test material using ethanol as a vehicle. The preparation of the test solutions does not indicate that undissolved test material is removed; however, this is considered negligible, because no mortality was observed in any treatment and the control throughout the test period of 96 h. Therefore, an LC50 > 5 mg/L (nominal) could be determined, corresponding to an LC50 > 4.11 mg/L (measured). In conclusion, no toxic effects occurred up to the limit of water solubility.

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 effects to fish 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 category support the hazard assessment of each category member by showing a consistent pattern of results, i.e. no toxic effects to fish or other aquatic organisms were observed up to the limit of water solubility.