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Long-term toxicity to aquatic invertebrates

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No effects being observed at the water solubility limit and at the highest loading rate tested for all of the three trophic levels (fish, aquatic invertebrates and algae) in tests of Annex VII and VIII, no aquatic PNEC were derived. Therefore, a long-term toxicity test to aquatic invertebrates was proposed to be carried out according to OECD testing guideline 211.

One year is necessary to perform the test, to run the chemical safety assessment and to update the dossier. Indeed, it takes about 3 months to start the study (getting a quotation, obtaining and shipping the substance sample, designing the study plan and finding a slot). CROs need 4-5 months to perform the tests (preliminary and final). The test substance is also identified as a difficult substance in accordance with the OECD guidance on aquatic testing of difficult substances and mixtures Number 23. It is indeed highly insoluble. The preparation of the test substance solution will be complex and require technical adaptations in CRO.