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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.

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. Glycerides, C16-18 mono-, di- and tri- (CAS No. 91052-54-9) is a readily biodegradable and poorly soluble substance (< 0.15 mg/L). Due to these characteristics, extensive biodegradation and adsorption to activated sludge within conventional STPs can be expected and therefore, only low concentrations, if any, are likely to be released into the water phase. Fish exposure to this substance is thus expected to be low. Furthermore, the acute tests conducted with fish (on a suitable read-across substance) showed no mortality after 96 hours of exposure, under semi-static conditions. The reports evaluating the acute and chronic toxicity to Daphnia magna (read-across) reported no effects up to the limit of water solubility either (EL50 (48 h) > 100 mg/L and NOELR (21 d) ≥ 10 mg/L (nominal, loading rate), for short and long-term studies, respectively). The study conducted with algae (read-across) showed low toxicity to Desmodesmus subspicatus (NOELR (72 h) = 32 mg/L, nominal concentration). The observed effects are well above the water solubility and therefore, physical effects due to interference or adsorption of the substance to algal cells are not excluded.

Based on the short term values, fish cannot be identified as the most sensitive organism. According to the Guidance on information requirements and chemical safety assessment, Chapter R7.b (ECHA, 2008), long-term toxicity testing on 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. Considering this information, long-term toxicity testing on fish species is not deemed necessary.