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Ecotoxicological information

Long-term toxicity to fish

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The chemical safety assessment according to Annex I of Regulation (EC) No. 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, 2014), 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 should be preferred instead of fish. Since no effects were observed or are expected in acute aquatic studies for 3,5,5 trimethylhexanoic acid, mixed esters with dipentaerythritol (CAS 84418-63-3), fish cannot be identified as the most sensitive organism, and consequently long-term testing of Daphnia magna was preferred, as recommended by the Guidance document. This long-term daphnia study is still ongoing, but the dossier will be updated as soon as possible and the Chemical Safety Assessment according to Annex I of the Regulation (EC) No 1907/2006 will be re-evaluated based on the outcome of this new study.