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Ecotoxicological information

Short-term toxicity to fish

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Link to relevant study record(s)

Description of key information

No toxic effects up to the limit of water solubility for fish (OECD 203).

Key value for chemical safety assessment

Additional information

In accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to structurally related category members was performed in order to fulfil the data requirements according to Annex VII-IX. 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.

Short-term toxicity of decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS No. 71010-76-9) to freshwater fish was investigated according to OECD 203 under static conditions using Brachydanio rerio as 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 (< 0.02 mg/L, purified water).

One study investigating the short-term toxicity of decanoic acid, mixed esters with octanoic acid and pentaerythritol (CAS No. 68441-68-9) to freshwater fish is available. The study is conducted under semi-static conditions according to ISO guideline 7346-1 using Brachydanio rerio as test organism (Gode & Richterich, 2008). Test concentrations of 1000, 3000 and 10000 mg/L are applied. No mortality is observed in the 1000 and 3000 mg/L treatments. Mortality is observed in the 10000 mg/L treatment; however, as undissolved test material is not removed from the test vessels it is considered that the observed toxicity is caused by physical interferences rather than systemic toxicity. Hence, the 96 h-LC50 is determined to be > 3000 mg/L based on the nominal test concentration.

One study, investigating the short-term toxicity to freshwater fish, was available for pentaerythritol tetraesters of n-decanoic, n-heptanoic, n-octanoic and n-valeric acids (CAS-No. 68424-31-7). This semi-static study (Combert and Caunter, 1991) with Salmo gairdneri equivalent or similar to OECD 203 determined LC50 (96h) > 1000 mg/L (nominal). No mortality was observed within the tested concentration (1000 mg/L nominal) during 96h exposure. As the test material did not dissolved completely in the dilution water, the tested concentration demonstrated a worst case. Due to the low water solubility of the test substance (< 1 mg/l), no toxicity was observed in the range of water solubility of the test substance.

One study, investigating toxic effects of fatty acids, C6-18, triesters with trimethylolpropane (CAS 91050-88-3) to freshwate fish, Danio rerio, according to OECD 203, is available. The limit test under static conditions (Bouillon, 2011) resulted in a LL50 (96h) > 1000 mg/L (Water Accomodated Fraction).

These results were supported by a study conducted according to EPA OTS 797.1400 investigating the toxicity of fatty acids, C8-10 mixed esters with dipentaerythritol, isooctanoic acid, pentaerythritol and tripentaerythritol (CAS 189200-42-8) on Pimephales promelas. No effects were observed up to the highest tested concentration (5 mg / L) after a 96 h exposure period.

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 that fatty acids, C8, C10, C12, C14, C16 esters with pentaerythritol, reaction product of coconut oil fatty acids, C8-10 fatty acid mix and pentaerythritol (CAS-No. 85049-33-8) will not exhibit short-term toxic effects to freshwater 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 summary, all reliable data in the category support the hazard assessment of each category member by showing a consistent pattern of results; no toxicological effects up to the limit of water solubility.