Fatty acids, C16-18 and C18-unsatd., Et esters

Endpoint summary

Additional information

Experimental data on the toxicity of Fatty acids, C16-18 and C18-unsatd., ethyl esters (CAS 85049-36-1) to terrestrial organisms are not available. However, based on the ecotoxicological profile toxicity of the substance to terrestrial organisms is considered as unlikely. The substance is characterised by a low water solubility (WS <0.05 mg/L). The Guidance on information requirements and chemical safety assessment, Chapter R7.b (ECHA, 2012) states that once insoluble chemicals enter a standard STP, they will be extensively removed in the primary settling tank and fat trap and thus, only limited amounts will get in contact with activated sludge organisms. Consequently a significant release to the environment of the substance via STP effluents is not expected and thus an exposure of terrestrial organisms is unlikely. However, when terrestrial organisms are exposed to the substance toxic effects are not expected as demonstrated by a short-term toxicity study with earthworms available for the analogue substance isopropyl myristate (CAS 110-27-0). The toxicity of isopropyl myristate (CAS 110-27-0) to earthworms was evaluated by Steber (1999). Eisenia fetida was exposed to the test substance for 14 days at a concentration of 20,000 mg/kg dw (limit test). No effects on survival during the exposure period were reported, leading to a LC50 (14 d) > 20,000 mg/kg dw.

As stated by ECHA Guidance R.7c the absence of chronic or long-term toxicological effects in aquatic organisms up to the substance solubility limit, can be used as part of a Weight of Evidence argument to modify/waive the data requirements of Annex IX and X. Since no effects on Daphnia were observed up to the limit of water solubility in the available chronic toxicity study it is assumed that long term tests on terrestrial organisms will not result in a different outcome. Furthermore, bioaccumulation or biomagnification through the food chain of the substance is not likely. Though the high log Pow value (log Pow >7) indicates a potential of the substance to bioaccumulate a relevant uptake is not likely. Due to a metabolization via enzymatic hydrolysis a relevant uptake and bioaccumulation in terrestrial organisms is not expected. This is supported by low BCF values (13.08 - 25.17 L/kg.; Arnot-Gobas) calculated for the substance indicating a low bioaccumulation potential. Overall, the substance is unlikely to pose a risk to terrestrial organisms based on a) the lack of exposure and b) the lack of adverse effects and low bioaccumulation potential.