N,N'-ethane-1,2-diylbisoleamide

Endpoint summary

Additional information

 The toxicity of Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis to terrestrial organisms will be evaluated in a read across approach. In accordance with Regulation (EC) No 1907/2006, Annex XI, Section 1.5 a read across to the structurally similar analogue substance Amides, C16-C18 (even), N,N’-ethylenebis will be conducted to fulfil the data requirements according to Annex IX for Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis with regard to long-term toxicity to soil macroorganisms. This read across is justified in detail in the analogue justification in IUCLID Section 13. 

 The study is not yet available since a testing proposal according to OECD 222 was submitted for the read-across substance Amides, C16-C18 (even), N,N’-ethylenebis. However, no additional test with soil macroorganisms will be proposed for Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis. The Chemical Safety Assessment according to Annex I of Regulation (EC) No 1907/2006 will be re-evaluated based on the outcome of the proposed study for the suitable read-across substance. 

 The test substance is characterized by a high log Koc (log Koc > 5) indicating a potential for adsorption to the soil particles. Thus, tests with soil-dwelling organisms which allows potential uptake via surface contact, soil particle ingestion and pore water (Guidance on information requirements and chemical safety assessment, Chapter R.7c, (ECHA, 2017)), are most relevant for the evaluation of soil toxicity of Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis. 

 In addition, Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis did not exert toxicity to any of the aquatic organisms used in the experimental studies available. In the absence of a clear indication of selective toxicity, an invertebrate (earthworm or collembolan) test is preferred according to Guidance on information requirements and chemical safety assessment, Chapter R.7c, (ECHA, 2017). Then, no higher toxicity to plants than to soil macroorganisms is expected. In addition, due to the high potential for adsorption to the soil particles and the low water solubility (< 0.01 mg/L), only low concentrations are expected in the pore water, which is the main exposure route for terrestrial plants. Thus, it can be assumed that soil macroorganisms would be highly exposed to toxicants in soil and hence would be most sensitive to the potential adverse effects of the substance. 

 Moreover, no higher toxicity of the test substance is expected for terrestrial microoganisms compared to soil macroorganisms. Amides, C16-C18 (even), N,N’-ethylenebis shows no inhibition to aquatic microorganisms up to a concentration of 1000 mg/L. The applied test concentration is well above the in the range of concentration that can be expected in the influent of a sewage treatment plant, as the substance has low water solubility (< 0.01 mg/L). The ECHA Guidance Document R.7c (ECHA, 2017) states that a test on soil microbial activity will only be additionally necessary for a valid PNEC derivation if inhibition of sewage sludge microbial activity has occurred. Therefore, toxicity to soil microorganisms is considered to be unlikely. 

 According to Guidance on information requirements and chemical safety assessment, Chapter R.7c, (ECHA, 2017) new long-term testing only needs to be conducted where the data on aquatic effects are insufficient to complete the Chemical Safety Assessment. All reliable aquatic acute and chronic data show no effects up to the water solubility limit identifying no risks. In addition, the absence of chronic or long-term effects in aquatic organisms up to the water solubility limit, is a clear indicator to waive the data requirements of Annex IX based on low intrinsic toxicity of the substance (ECHA, 2017). 

 According to Regulation (EC) No 1272/2008 (CLP) terrestrial toxicity data are not required for Classification & Labelling of substances. Terrestrial data are only required for PNEC soil derivation in the Chemical Safety Assessment for the identification of potential hazards of the substance to the terrestrial environment. As outlined in the Guidance on information requirements and chemical safety assessment, Chapter R.7c, (ECHA, 2017) it is normally not possible to derive a robust PNEC soil from acute aquatic toxicity testing showing no effects, this applies in particular to poorly soluble substances. Thus, soil toxicity data are required to confirm a PNEC for the soil compartment (ECHA, 2017). Using the chronic soil toxicity test with earthworm from the read-across substance (if available), a robust derivation of PNEC soil for the risk assessment could be calculated. Thus, the PNEC soil based on experimental data will be used for evaluation of the PEC/PNEC ratio. 

 In conclusion, due to the following reasons no study for terrestrial organisms need to be conducted: 

 - A new study for macroorganisms is planned to be conducted for a structurally similar analogue substance which allows to assess several potential routes of uptake. 

 - No selective toxicity indicated 

 - Toxic effects on aquatic microorganisms or long-term effects on aquatic organisms up to the water solubility limit were not observed. 

 - The chronic soil toxicity test with macroorganisms from the read-across substance (if available) will be used for a robust derivation of PNEC soil.