Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Additional information

An estimated half-life of more than 1 year at pH 4, 7 and 9 at a temperature of 25°C indicates that the substance is stable to hydrolysis under environmentally relevant conditions. Potential exposure is therefore to the parent material.

Information on phototransformation in air, water and soil is not available. It is not a standard information requirement under REACH and there is no indication from the CSA on the need to investigate further the fate and behaviour of the substance.

Lemonile is considered not to be readily biodegradable based on the strict criteria for this effect, however, it is considered to be inherently biodegradable and not persistent based on positive results from enhanced ready biodegradation tests where pass levels of 60% were achieved within 42-45 days and biodegradation levels of up to 73% obtained by day 60. The parent substance is further confirmed as not P/vP from chemical specific analysis performed in one of the studies, which showed that no parent substance remained at the end of the test.Two potential primary metabolites, the corresponding acid and corresponding amide, were also quantitatively analysed. The concentration of the acid metabolite was below the limit of quantification throughout the test, while the concentration of the amide metabolite analytical target increased slightly up to days 14-21 and then declined to be non-detectable by the end of the test.These results coupled with the high % ThOD at the end of the test (73%, day 60) indicate that any metabolites formed following primary degradation are transient and not persistent.

Lemonile is not considered to be potentially bioaccumulative for the purpose of classification and labelling according to CLP and for the PBT assessment based on its measured log Kow of 3.1 to 3.2. Furthermore, BCF estimates ranging from 37 to 105 L/kg indicate the substance is not bioccumulative.

A log Koc value of 3.0 indicates the substance is not highly adsorptive and that soil and sediment are not expected to be the main target compartments for exposure assessment. However, the low to moderate potential to adsorb to organic material suggests some removal from a waste water treatment plant via e.g. sewage sludge, may occur. Model estimates are 9.7% for release to sludge in a WWTP (see chapter 9 of CSR).