Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

In accordance with Annex IX, column 2, 9.4 or Regulation (EC) No 1907/2006, effects on terrestrial organisms do not need to be investigated since a direct and indirect exposure of the soil compartment is unlikely. A direct exposure of the soil compartment is negligible based on the identified uses (refer to IUCLID Section 3.5). The identified uses for Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters include industrial uses (defined by ERC2 - ERC7) for which the direct exposure to agricultural soil can be excluded since it is assumed that soil at industrial plants is sealed. This is also indicated by available spERCs from industry associations AISE and COLIPA indicating 0% release to soil. Soil exposure by wide-dispersive outdoor use (defined by ERC 8d-f, ERC 9b, ERC10a and ERC10b) is unlikely. The use of applicable spERCs (AISE and COLIPA) exclude exposure to soil based on a release rate of 0% to agricultural soil. An indirect exposure to the land via activated sludge application from exposed STPs is unlikely because the substance is readily biodegradable. The Guidance on information requirements and chemical safety assessment, Chapter R7c (ECHA, 2012) states that generally, for readily biodegradable substances without direct application to soil, exposure of the terrestrial compartment is excluded and as such, there is no need for testing on soil organisms. Moreover application via irrigation is negligible since the substance is not used in products intended to be used in agriculture and has low water solubility (4 - 5 mg/L). These theoretical assumptions were clearly confirmed by the quantitative environmental exposure assessment according to Annex XI, Section 3.1 of Regulation (EC) No 1907/2006. All Risk Characterisation Ratios (RCR) are < 1.

Taking all these information into account it can be assumed that direct and indirect exposure of the soil compartment is unlikely and no testing with terrestrial organisms is deemed necessary.