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Long-term toxicity to aquatic invertebrates

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Description of key information

No effects up to the limit of water solubility (OECD 211); read-across

Key value for chemical safety assessment

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Since no studies investigating the long-term toxicity of Tetraesters of pentaerythritol with 2-ethylhexanoic acid, heptanoic acid and nonanoic acid (EC 806-879-4) to aquatic invertebrates are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substances Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) and Hexanoic acid, 2-ethyl-, pentaerythritol tetraester (CAS 7299-99-2) was conducted.

The source substances are representative to evaluate the long-term toxicity of Tetraesters of pentaerythritol with 2-ethylhexanoic acid, heptanoic acid and nonanoic acid (EC 806-879-4) to aquatic invertebrates. The target substance is characterized as a tetraester of pentaerythritol and different fatty acids (C7, C9 and 2-ethylhexanoic acid). Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid is a tetraester of C5/C7/C9/C10 with pentaerythritol whereas Hexanoic acid, 2-ethyl-, pentaerythritol tetraester covers the content of 2-ethylhexanoic acid present in the target substance (2-ethylhexanoic acid tetraester with pentaerythritol). All substances share similar physico-chemical properties, only differ in the distribution of chain lengths of the fatty acid and do not share any functional group which might increase aquatic toxicity the read-across is suitable to investigate the aquatic toxicity using read-across. This read-across is justified in detail in the overall summary (IUCLID Section 6.1) and within the analogue 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 study with the source substance decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) investigated the long-term toxicity aquatic invertebrates (Letinski & Bragin, 2011). The GLP study was conducted under semi-static conditions according to OECD 211 using Daphnia magna as test organism. A loading rate of 135 mg/L (nominal) was applied in the limit test. The WAF solution was prepared by adding the appropriate amount of test substance with subsequent stirring and sampling of the aqueous portions (WAFs) through the outlet at the bottom of the vessels. No significant effect on reproduction was observed in the treatment throughout the test period of 21 d. Hence, the NOELR (21 d) is determined to be ≥ 135 mg/L on the basis of the nominal loading rate.

The second study with the source substance Hexanoic acid, 2-ethyl-, pentaerythritol tetraester (CAS 7299-99-2) investigated the chronic toxicity to Daphnia magna in a semi-static test according to OECD 211 and GLP (MOE, 2005). A limit test at a concentration of 0.16 mg/L was performed. The actual test concentrations were verified by LC-MS and resulted in a time-weighted average (TWA) concentration of 0.0132 mg/L throughout the exposure period. No inhibition of reproduction was recorded after 21 d resulting in a NOEC (21 d) ≥ 0.0132 mg/L (measured, TWA).

Based on the available result from two 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 and comparable structure, it can be concluded that Tetraesters of pentaerythritol with 2-ethylhexanoic acid, heptanoic acid and nonanoic acid (EC 806-879-4) will not exhibit long-term effects to aquatic invertebrates up to the limit of water solubility.

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