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Long-term toxicity to fish

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Description of key information

According to Regulation (EC) No. 1907/2006, Annex IX, Column 2, 9.1.6, the testing of the long-term to fish is not required.

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Additional information

The substance Fatty acids, C18-unsatd., dimers, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynemethanol (CAS 162353-70-0) is readily biodegradable and poorly soluble in water (< 1 mg/L). Due to these characteristics, extensive elimination of the substance in conventional STPs can be expected. Therefore, only low concentrations, if any, are likely to be released into the water phase. Exposure of aquatic organisms like fish is thus expected to be low. Furthermore, read across data on short-term toxicity available for all three trophic levels (fish, aquatic invertebrates and algae) indicate no potential for aquatic toxicity. Chronic effects of the substance are not expected based on the environmental fate and on the data on acute toxicity of the substance. According to the Guidance on information requirements and chemical safety assessment Chapter R.7b: Endpoint specific guidance (ECHA, 2016), long-term testing of fish should only be conducted if it represents the most sensitive taxonomic group. The Guidance states that if aquatic invertebrates are likely to be more sensitive than fish and algae or the relative sensitivity of invertebrates cannot be predicted, long-term testing on Daphnia sp. should be preferred instead of fish. Furthermore the available read-across study on Daphnia magna, conducted withFatty acids, C16-18 and C18-unsatd., triesters with trimethylolpropane (CAS 68002-78-8), determined no adverse effects (NOELR (21 d) ≥0.11 g/L, nominal). Taking all this information into account, further long-term testing with fish is not considered necessary and was thus omitted.

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