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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.

Key value for chemical safety assessment

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Since no studies investigating the long-term toxicity of Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, tri- and tetraesters with pentaerythritol 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 Fatty acids, C16-18 and C18-unsatd., esters with pentaerythritol (CAS 85711-45-1) and Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) was conducted. The target substance is mainly characterized as a tetraester of pentaerythritol and C16-C18 branched, saturated and unsaturated fatty acids. The source substance Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) is a tetraester of pentaerythritol and mainly C5, C7 and C8 fatty acids. Fatty acids, C16-18 and C18-unsatd., esters with pentaerythritol (CAS 85711-45-1) is mainly characterized as a tetraester of C16 and C18 saturated and unsaturated fatty acids. The use of the source substance Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) is a worst case read-across since this substance may have a higher bioavailability to aquatic organisms based on its smaller molecular size and expected higher solubility in water.

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 substance was used for the assessment.

The first study investigated the long-term toxicity of the source substance Fatty acids, C16-18 and C18-unsatd., esters with pentaerythritol (CAS 85711-45-1) to aquatic invertebrates . The GLP study was conducted under semi-static conditions according to OECD 211 using Daphnia magna as test organism. A loading rate of 1 mg/L (nominal) was applied in the limit test. No significant effect on reproduction, mean age of first brood and immobilisation was observed in the treatment throughout the test period of 21 d. A difference between the mean length of the control and treatment group was < 10% (i.e. 6.04%) and is therefore be considered as biologically not relevant. Hence, the NOELR (21 d) is determined to be ≥ 1 mg/L on the basis of the nominal loading rate, i.e. no effects occurred up to the limit of water solubility (< 0.05 mg/L).

The second study investigated the long-term toxicity of the source substance decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) to aquatic invertebrates. 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.

Based on the available results from a structurally related read-across substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by a similar ecotoxicological profile and comparable structure, it can be concluded that Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, tri- and tetraesters with pentaerythritol will not exhibit short-term effects to aquatic invertebrates up to the limit of water solubility.

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