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Short-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

Additional information

Since no studies investigating the short-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 substance Fatty acids, C16-18 and C18-unsatd., tetraesters with pentaerythritol (CAS 68604-44-4) 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 Fatty acids, C16-18 and C18-unsatd., tetraesters with pentaerythritol (CAS 68604-44-4) is mainly characterized as a tetraester of C18 unsaturated fatty acids.

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.

Two studies are available investigating the short-term toxicity of the source substance Fatty acids, C16-18 and C18-unsatd., tetraesters with pentaerythritol (CAS 68604-44-4) to aquatic invertebrates.

The first study was conducted according to EU Method C.2 (GLP) with Daphnia magna as test organism. Due to the low water solubility of the substance, the test solutions were prepared as Water Accommodated Fractions (WAF) to ensure that no insoluble particles were present in the test solutions to avoid physical effects. The WAF was prepared by adding the appropriate amount of test substance to the test solution with subsequent stirring and a filtration step. A nominal loading rate of 100 mg/L was tested, corresponding to a measured concentration of < 10 mg/L (detection limit). No immobilization was observed in the treatment and the control throughout the test period of 48 h. Hence, the EL50 (48 h) is determined to be > 100 mg/L based on the nominal loading rate. This result is confirmed by a supporting non-GLP study, conducted according to OECD 202. No effects on mobility of the test organisms were recorded at a nominal loading rate of 100 mg/L. Thus, an EL50 (48 h) > 100 mg/L based on nominal loading rate was determined.

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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