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Long-term toxicity to fish

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Experimental data on the long-term toxicity of Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS 68604-38-6) to fish are not available. The chemical safety assessment according to Annex I of Regulation (EC) 1907/2006 does not indicate the need to investigate further the long-term toxicity to fish. Thus, in accordance to Annex IX, column 2, no further long-term toxicity test to fish is proposed.

According to the Guidance on information requirements and chemical safety assessment Chapter R.7b: Endpoint specific guidance, R.7.8.5.3 (ECHA, 2012), long-term testing of fish should only be conducted if it represents the most sensitive taxonomic group. The Guidance states that if 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. The acute toxicity testing demonstrated no toxic effects of Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS 68604-38-6) to fish. Since fish cannot be identified as the most sensitive organism, a long-term test on Daphnia magna was conducted as recommended by the Guidance document. Testing according to OECD guideline 211 demonstrated no toxic effects of the substance on survival and reproduction of Daphnia magna up to the limit of water solubility (NOEC (21 d) ≥ 100 mg/L) (Caduff, 2013). Based on the available data long-term toxic effects of Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS 68604-38-6) on fish are not to be expected. Therefore and for reasons of animal welfare, long-term testing on fish is not proposed.

A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within CSR.