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Ecotoxicological information

Long-term toxicity to fish

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Description of key information

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.

This substance is part of the Dossier Improvement Pilot Project (DIP) as a member of the category “Epoxidized fatty acid esters (EFAE)”, as agreed upon by the European Chemicals Agency (ECHA) and the European Chemical Industry Council (CEFIC).

To confirm the hypothesis a testing proposal for long-term toxicity to fish for Fatty acids, C16-18 and C18-unsatd., Me esters, epoxidized (CAS 158318 -67 -3) is submitted.

Key value for chemical safety assessment

Additional information

According to Regulation (EC) No. 1907/2006, Annex IX, Column 2, 9.1.6, long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms.

Fatty acids, C16-18 and C18-unsatd., Me esters, epoxidized (CAS 158318 -67 -3) is a readliy biodegradable and a low water soluble substance.

Due to these characteristics(mainly the readiliy biodegradability), extensive biodegradation and adsorption to activated sludge within conventional STPs can be expected and therefore, only low concentrations are likely to be released into the water phase and directly bioavailable to fish species. Furthermore, the acute fish tests showed no toxic effects of the substance after 96 and 48 h respectively . The other acute studies available for aquatic invertebrates and algae also showed no toxicity. Based on the results of the acute tests, fish species are not expected to show a higher sensitivity compared to aquatic invertebrates and therefore, considering this fact and all the above arguments, long-term toxicity testing on fish is not deemed necessary for the hazard assessment of Fatty acids, C16 -18 and C18 -unsatd., Me esters, epoxidized.