Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Additional information

There are no data available on the biodegradation ofthe target substance. In order to fulfil the standard information requirements, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted.

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.”

Having regard 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 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity. Please refer to IUCLID section 13 for a detailed justification of the category approach.

The target substance is a racemic mixture of D-, and L-menthol.The source substances L-menthol (CAS 2216-51-5), D-menthol (CAS 15356-60-2) and D/L-menthol (CAS 1490-04-6) are stereo-isomers of the target substance.This allows the use of experimental data from D-menthol and L-menthol for the assessment of the target substance.

Based on the results from two experimental studies according to OECD 301D it can be concluded that the target substance is readily biodegradable according to the OECD criteria (79 - 92% biodegradation after 28 d based on O2 consumption). The degradation via abiotic hydrolysis is not considered to be a relevant degradation pathway in the environment, since the target substance has no functional chemical groups allowing hydrolysis under environmental conditions.
Considering the water solubility of 231 mg/L and the low potential for adsorption to organic soil and sediment particles (log Koc: 1.94 - 2.28 L/kg, mean: 2.11, KOCWIN v2.00), the main compartment for environmental distribution is expected to be the surface water. Evaporation into air and the transport through the atmospheric compartment is not considered to be relevant based on the Henry’s Law Constant of 1.54 - 2.6 Pa m³/mole (HenryWin v3.20) and a vapour pressure of 3.6 Pa at 25 °C.

The potential for bioaccumulation was assessed based on an experimental study according to OECD 305C performed with the source substance D/L-menthol (CAS 1490-04-6). This study resulted in a BCF of ≤ 15 L/kg indicating a low potential for bioaccumulation. Thus, the substance is not considered to meet the B/vB criterion to classify the substance as bioaccumulative and very bioaccumulative.