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Long-term toxicity to fish

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In accordance with REACH Regulation Annex IX, 9.1, column II, long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on aquatic organisms. The risk assessment according to Annex I of the REACH regulation (EC) No 1907/2006, based on the result from the short-term tests, reveals an acceptable risk (PEC/PNEC <1) of Oxooil LS9 on aquatic organisms. Therefore, the effect of Oxooil LS9 on aquatic organism does not need to be investigated further and a long-term test with fish is not required. Additionally, the PNEC for the aquatic environment is derived from short-term toxicity tests with a conservative assessment factor. Short-term aquatic toxicity was investigated for three trophic levels (fish, aquatic invertebrates and algae) using water accommodated fractions (WAFs). The most sensitive species for acute aquatic toxicity is Daphnia magna with an EC50 (48 h) of 12 mg/L nominal loading rate WAF and a NOEC of 5.6 mg/L nominal loading rate WAF (OECD TG 202). Oxooil LS 9 is therefore evaluated as harmful to aquatic organisms. Oxooil LS9 is not actualy harmful to fish (LC50 (96 h, semi static)> 100 mg/l and NOEC 10 mg/l nominal loading rate (WAF)). Furthermore, for the conclusion on the chemical safety assessment it in the guidance document (Chapter R.7b) it is mentioned that if there is compelling evidence that the fish is likely to be at least a factor of about 10 less sensitive than invertebrates or algae there are no further requirements for fish testing (page 58).