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

Endpoint summary

Additional information

In accordance with Article 13 (1) of Regulation (EC) No. 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met. In particular, information shall be generated whenever possible by means other than vertebrate animal tests, through the use of alternative methods, for example, in vitro methods or qualitative or quantitative structure-activity relationship models or from information from structurally related substances (grouping or read-across).” According to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No. 1907/2006, substances may be considered as a group provided that their physicochemical and toxicological are likely to be similar or follow a regular pattern as a result of structural similarity. The substances within the analogue approach are considered to apply to these general rules, and the similarity is justified on basis of scope of variability and overlapping of composition, representative molecular structure, physico-chemical properties and toxicological profiles. There is convincing evidence that these chemicals lie in the overall common profile of this analogue approach. This read across is justified in detail in the analogue justification in IUCLID Section 13.

There are no experimental studies available in which the aquatic toxicity of Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis has been assessed. Therefore, read-across based on the analogue approach from the structurally related source substance Amides, C16-C18 (even), N,N'-ethylenebis is performed to cover the aquatic toxicity.

The target substance and the source substance are both secondary fatty acid amides. Short term tests with species of 3 trophic levels and a long-term toxicity study to invertebrates are available for the structurally related substance Amides, C16-C18 (even), N,N’-ethylenebis.

The results from these studies show that the substance did not cause any short term effects to fish, Daphnia and algae up to the limit of water solubility. The same applies for the long-term Daphnia study according to OECD 202, detecting no effects up to the limit of water solubility of the tested substance.

Based on the results from the activated sludge respiration inhibition study of the source substance, the target substance is not expected to exhibit effects on the microorganism community in sewage treatment plants, either, and inhibition of the subsequent degradation process is not expected.

Both secondary fatty acid amides can be regarded as not harmful to aquatic organisms.

Short-term toxicity to fish

The short-term toxicity of Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis to fish was assessed in a read across approach using data from the structural analogue Amides, C16-C18 (even), N,N'-ethylenebis. The results from this study show that after 96 h exposure to the test substance, no effects were observed up to the highest attainable concentration (0.027 mg/L, limit of solubility). Therefore, the LC50 (96 h) was > 0.027 mg/L, and no toxicity within the range of water solubility was reported.

Short-term toxicity to aquatic invertebrates

The short-term toxicity of Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis to aquatic invertebrates was assessed in a read across approach using data from the structural analogue Amides, C16-C18 (even), N,N'-ethylenebis. The results from this study show that after 96 h exposure to the test substance, no effects were observed up to the highest attainable concentration (0.027 mg/L, limit of solubility). Therefore, the LC50 (96 h) was > 0.027 mg/L, and no toxicity within the range of water solubility was reported.

Long-term toxicity to aquatic invertebrates

The long-term toxicity of Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis to aquatic invertebrates was assessed in a read across approach using data from the structural analogue Amides, C16-C18 (even), N,N'-ethylenebis. After 21 d of exposure to the test substance no effects on reproduction were reported up to the highest attainable concentration (0.0056 mg/L, limit of solubility). Therefore, the EC50 and NOEC (21 d) were > 0.0056 mg/L, and no toxicity within the range of water solubility was observed.

Toxicity to aquatic algae

The toxicity of Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis to algae was assessed in a read across approach using data from the structural analogue Amides, C16-C18 (even), N,N'-ethylenebis. No effects on growth rate of Pseudokircheneriella subcapitata were observed up to the highest attainable concentration (0.053 mg/L, limit of solubility). Therefore, the EC50 and the NOEC (72 h) were > 0.053 mg/L, and no toxicity within the range of water solubility was reported.

Toxicity to microorganisms

The toxicity of Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis to microorganisms was assessed in a read across approach using data from the structural analogue Amides, C16-C18 (even), N,N'-ethylenebis. The results from this test show no effects on the respiration rate of activated sludge up to the highest nominal test concentration of 1000 mg/L. Therefore, the EC10 and EC50 (3 h) were determined to be ≥ 1000 mg/L. Disturbances in the biodegradation process of activated sludge are not anticipated.