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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

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 testing with fish is proposed.

The substance is considered to be readily biodegradable and according to the Guidance on information requirements and chemical safety assessment, Chapter R.7b, readily biodegradable substances can be expected to undergo rapid and ultimate degradation in most environments, including biological Sewage Treatment Plants (STPs) (ECHA, 2017). Thus, concentrations discharged to the aquatic environment via the effluent of STPs are expected to be very low.

One long-term study with aquatic invertebrates is available. As aquatic invertebrates are the most sensitive organism and fish are not expected to be more sensitive in long-term testing compared to invertebrates, no further long-term study is required for fish. Furthermore, due to animal welfare a test with vertebrates should be avoided. In addition, the environmental exposure assessment for N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3) indicates no risk for the aquatic compartment (all RCR < 1; please refer to Chapter 9 and 10 of the Chemical Safety Report for detailed information). According to Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7b: Endpoint specific guidance (ECHA, 2017) long-term testing with fish is not necessary, if PEC/PNEC is < 1 based on the Daphnia long-term result.

Furthermore, the substance has a low potential for bioaccumulation (see chapter 5.3.1), i.e. based on log D < 4.5, metabolisation and excretion and BCF values of 3.16 – 264.5 L/kg wet-wt (EPI Suite v4.11). Thus, the substance is not expected to bioaccumulate in aquatic species. 

Based on all available data, chronic exposure of aquatic organisms is unlikely. Based on the results of the chemical safety assessment and the low bioaccumulation potential no further long-term test with freshwater fish is proposed for N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3).