Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

No experimental data investigating the toxicity of Fatty acids, C16-18, methyl esters (CAS No. 85586-21-6) to soil organisms are available. According to Regulation (EC) No. 1907/2006, Annex IX, Column 2, 9.4, these studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely. Based on the uses listed for Fatty acids, C16-18, methyl esters, this substance is not directly applied to the soil. On the other hand, indirect exposure to soil via sludge application into land is unlikely due to its ready biodegradability. Fatty acids, C16-18, methyl esters has a low vapour pressure (< 0.008 Pa), indicating that the substance will not be present in the atmosphere at significant amounts. Nevertheless, if released into the air, the available estimated half-lives (< 24 h), calculated using AOPWIN v1.92 (EPISuiteTM) indicate that this substance is susceptible to undergo rapid indirect photodegradation in air. Based on this information, aerial deposition of Fatty acids, C16-18, methyl esters into soil can be considered negligible.

According to the Guidance on information requirements and chemical safety assessment, R7.C (ECHA, 2008) generally, in the case of readily biodegradable substances which are not directly applied to soil it is assumed that the substance will not enter the terrestrial environment and as such, no testing on soil organisms is required.

As this is the case for Fatty acids, C16-18, methyl esters, no testing on soil organisms is proposed for this substance.