Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Short term tests with species of 3 trophic levels are available and based on this tests, the test substance can be regarded as acutely not harmful to aquatic organisms.Short term toxicity data of the substance towards fish, daphnia and algae give a NOEC greater than the water solubility of amides, C16-18 (even numbered). No toxicity could be observed in any test.

Additionally, long term test with the structural related erucamide are conducted. Erucamide (CAS 112-84-5), is the fatty acid amide resulting from the amidation of erucic acid. Erucic acid is a mono-unsaturated fatty acid with a carbon chain consisting of 22 carbon atoms with a double bond at position 13 (omega-9) of the carbon chain (cis-docos-13-enoic acid) and is therefore structural related to the registered substance which is an UVCB mixture containing also primarily palmitamide (CAS No. 629-54-9) and stearamide (CAS No. 124-26-5), which have the same functional groups and metabolic pathway. Both fatty acids are abundantly available in our daily nutrition and are utilised by fat metabolism. It is therefore considered valid to read-across the results for erucamide to fill the data gap for the registered substance. Additional information is given in a justification for analogue approach attached in Section 13 of the IUCLID 5 dossier.

The available study report on long-term toxicity of erucamide to fish conducted according to OECD 215 demonstrate no effect up to the limit of the water solubility of the tested substance. The same applies for a long term daphnia study according to OECD 202 for erucamide, detecting no effects up to the limit of the water solubility of the tested substance. Furthermore the inhibition of the degradation activity of activated sludge is not anticipated.

Thus, the amides, C16-18 (even numbered) can be regarded as not harmful for aquatic organisms.