Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

The toxicity of Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS 68604-38-6) to terrestrial organisms was tested in one available long-term toxicity test on earthworms. Specimens of the species Eisenia fetida were exposed to the substance in artificial soil according the specifications given in OECD guideline 222 (Hernádi, 2013). The mortality and growth of adult earthworms was determined after 28 days. Another 28 days later the reproduction rate was assessed adverse effects of the substance were not observed and thus a NOEC ≥ 1000 mg/kg was determined. Studies on other terrestrial organisms are not available but a toxicity of the substance to terrestrial organisms is considered as unlikely. Due to the low water solubility (< 0.15 mg/L) and the high log Koc (7.6 - 30.72) the substance will be largely mechanically removed in conventional STPs. Only limited amounts of substance are expected to enter the secondary treatment and get in contact with activated sludge organisms. Due to the high log Koc the substance is expected to be removed from the water column and will adsorb to sludge and suspended matter (Guidance on information requirements and chemical safety assessment, Chapter R.7a, (ECHA, 2012)). 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 the available studies on the acute and chronic toxicity to aquatic and terrestrial organisms. Due to the high adsorption potential an ingestion of the substance via food particles is possible. But as a result of metabolism via enzymatic hydrolysis of the substance a relevant uptake and bioaccumulation is not expected. The part of Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol that have become systemically available, might be hydrolysed and the cleavage products can be further metabolized. However, due to its high molecular weight, absorption of Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol is not likely and thus, no extensive metabolism is expected but rather direct elimination. In conclusion, a bioaccumulation or biomagnification through the food chain of the substance is not expected.
This also supported by the low BCF/BAF values (0.89 L/kg; Arnot-Gobas). For more information on metabolism please refer to IUCLID section 5.3 or Chapter 4.3 Bioaccumulation.
Overall, the substance is unlikely to pose a risk for terrestrial organisms based on a) the lack of exposure and b) the low toxicity of the substance for terrestrial organisms based on the available experimental data, metabolism considerations and the lack of adverse effects in aquatic ecotoxicity tests.

A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within CSR.