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Long-term toxicity to fish

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Description of key information

The intrinsic properties of the Substance indicate that significant and relevant long-term effects on fish will not occur (NOEC = 32 mg/L).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
32 mg/L

Additional information

The information requirements will be fulfilled using a weight-of-evidence approach based on the scheme provided in REACH Guidance Document R.7b (v4.0, ECHA, 2017: Figure R.7.8-2) and in accordance with Annex XI Section 1.2.  

Step 1: The structure as well as the physico-chemical properties of the Substance are clearly identified. In screening tests the Substance was found to be not readily biodegradable. However, in the water/sediment system the Substance has a half-life of 14.3 days under aerobic conditions. After 30 and 60 days of exposure 39% and 64% of the applied radioactivity were recovered as 14CO2, respectively, indicating that the Substance will not persist in aerobic aqueous compartments. In anaerobic media no biodegradation was observed after 6 month of exposure. In natural soil the Substance is mineralized to an extent of 66 to 72%. Therefore, the Substance is not rapidly or inherently biodegradable in regulatory terms but it does not persist in water/sediment systems due to degradation in surface water and in soil. The Substance is not P/vP.

Step 2: The substance does not produce an alert for protein binding in the schemes by OECD and OASIS (OECD QSAR Toolbox v4.4) which is an indication of the absence of elevated toxicity. According to the mode of action by OASIS (OECD QSAR Toolbox v4.4), the substance is a narcotic amine. The modified classification scheme of Verhaar is not suitable to classify the Substance. It can be concluded that critical long-term effects are not to be expected.  

Step 3 and 4: No experimental data are available on the long-term toxicity to fish for the Substance.  

Step 4a/b: Reliable QSAR predictions or in-vitro results for long-term toxicity to fish are not available.  

Step 5: Acute and long-term toxicity for the aquatic environment have been assessed by experimental data for the Substance itself as well as a QSAR approach on the long-term toxicity to aquatic invertebrates. Information on the long-term toxicity to fish are not available.  Fish are not the most sensitive aquatic trophic level (96-h LC50 = 3158 mg/L). The Substance is neither acutely nor chronically hazardous to the aquatic environment according to the CLP-Regulation (EC) No 1272/2008.  

The long-term toxicity to fish is derived using the Acute-to-Chronic (ACR) approach.

The ACR approach is an important method to predict acceptable no-effect values (NOEC) from acute toxicity data (LC50, EC50). The method is valuable for the risk assessment of chemical substances, which has been successfully assessed for several chemicals, including organic substances (including alkylamines) with a narcotic mode of action (modified acute aquatic toxicity classification of Verhaar) to which the Substance belongs (May et al., 2016; Kienzler et al., 2016; ECETOC, 2003). Based on these three publications, a conservative ACR of 100 was selected which covers at least 90% of all organic chemicals; therefore, the derived NOEC can be regarded as reliable and sufficiently protective. Based on the available 96-h LC50 of 3158 mg/L (BASF AG, 1987) a NOEC for the long-term toxicity to fish of 32 mg/L was derived. The available short-term as well as the long-term toxicity data do not lead to a classification of the Substance as chronically hazardous to the aquatic environment following the CLP-Regulation (EC) No 1272/2008.  With regard to the PBT assessment, further testing is also not required as the Substance is neither persistent (P) nor very persistent (vP). The Substance is also neither bioaccumulative (B) nor very bioaccumulative (vB) based on the low log Kow (log Kow < 3, see IUCLID Chapter 4.7) and the experimentally determined BCF (BCF << 2000 L/kg; NITE, 1992). The available short-term as well as the long-term toxicity data for the three trophic levels (fish, aquatic invertebrates and algae) do not indicate a concern for a high sensitivity of aquatic organisms. In addition, the Substance holds no relevant classification. Therefore, further testing does not seem justified and long-term toxicity testing on fish should therefore not be carried out to avoid unnecessary testing on vertebrate animals. Avoiding unnecessary testing of vertebrate animals is also in line with the REACH regulation, which states in §25 that testing on vertebrate animal shall be undertaken as a last resort. This is further supported by the EU Directive on the protection of animals used for scientific purposes (EU, 2010) and the EURL ECVAM strategy to replace, reduce and refine the use of fish in aquatic toxicity and bioaccumulation testing (EURL ECVAM, 2014).  Step 6: The intrinsic properties of the Substance indicate that significant and relevant long-term effects on fish will not occur. The Substance has no specific mode of action and does not produce structural alerts for relevant effects. The derived NOEC of 32 mg/L indicates that long-term effects on fish are not to be expected.  Therefore and in accordance with REACH Regulation 1907/2006, Annex XI, Section 1.2, further testing on vertebrate animals will be omitted for reasons of animal welfare. The Registrant will not perform a long-term toxicity test on fish.