[No public or meaningful name is available]

Toxicity to terrestrial arthropods

Link to relevant study record(s)

Reference

Endpoint:

toxicity to non-target arthropods on natural substrate (NTA other than pollinators)

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Description of key information

The chemical safety assessment according to Annex I of Regulation (EC) No. 1907/2006 does not indicate the need to investigate further the toxicity to terrestrial arthropods.

Additional information

In accordance with Regulation (EC) No 1907/2006, Annex X, column 2, 9.4 further studies on the effects on terrestrial organisms do not have to be conducted since short-term toxicity on soil macroorganism is available for a structurally and chemically closely related source substance showing no effects on survival or biomass during the exposure period.

Fatty acids, C16-18 (even numbered), esters with glycerol oligomers is characterised by a high log Koc (1.31 – 12.67, KOCWIN v2.00; MCI method) indicating a considerable potential for adsorption to soil particles. Therefore, tests with soil-dwelling organisms like earthworm which allows potential uptake via surface contact, soil particle ingestion and pore water (Guidance on information requirements and chemical safety assessment, Chapter R.7c, (ECHA, 2017)) are most relevant for the evaluation of soil toxicity of Fatty acids, C16-18 (even numbered), esters with glycerol oligomers.

According to ECHA guidance (Chapter R.7c: Endpoint specific guidance, 2017) new long-term testing only needs to be conducted where the data on aquatic effects are insufficient to complete the Chemical Safety Assessment. Since acute aquatic toxicity data are available for structurally and chemically closely related source substances for all three trophic levels and chronic toxicity data are available for aquatic invertebrates and algae the Chemical Safety Assessment can be evaluated completely. All reliable aquatic acute and chronic data show no effects up to the water solubility limit. As all acute toxicity effects range above 10 mg/L and no chronic or long-term effects in aquatic organisms up to the water solubility limit were observed, this can be used to waive the data requirements of Annex IX (Chapter R.7c: Endpoint specific guidance, 2017, page 148).

As the substance is considered readily biodegradable (94% biodegradation after 28 days; read-across) confirmed with QSAR calculations for representative constituents (VEGA (1.1.4); Ready Biodegradability Model (v1.0.9)), it is expected that an extensive elimination of the substance in sewage treatment plants will occur. According to the Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7b (ECHA, 2017), the ready biodegradability of a substance can be considered indicative of rapid and ultimate degradation in most environments, including biological sewage treatment plants (STP) where the substance will be extensively removed in the primary settling tank and fat trap. As a result of the high adsorption potential of the substance (log Koc = 1.31 – 12.67, KOCWIN v2.00; MCI method), a removal from the water column to a significant degree by adsorption to sewage sludge can be expected (Guidance on information requirements and chemical safety assessment, Chapter R.7b, (ECHA, 2017)). Thus, only limited amounts will get in contact with activated sludge organisms in STPs and the concentration of the substance in effluents of conventional STPs is presumably marginal. Therefore, discharged concentrations of these substances into the soil compartment are likely to be negligible.Considering this, one can assume that the availability of Fatty acids, C16-18 (even numbered), esters with glycerol oligomers in the soil environment is very low, which reduces the probability of exposure, in particular long-term exposure, of soil organisms in general.

Moreover, the bioaccumulation potential is low. Based on the physico/chemical properties such as poor water solubility and high potential for adsorption a reduced availability in water is expected. In addition, the available literature data showed that soil microorganisms are capable to break-up ester bonds and degrade fatty acids in significant amounts. Moreover, the data indicated the non-toxic properties of fatty acids since they can be used as energy source. It can be concluded that the bioaccumulation potential of Fatty acids, C16-18 (even numbered), esters with glycerol oligomers is negligible. This is supported by a low calculated BCF value ranged from 0.94 - 18.58L/kg ww (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic).With VEGA 1.1.3 BCF values of 0.74 - 2 L/kg were determined (Caesar v2.1.14) for the main components of the substance.

In conclusion, no effects in a short-term toxicity study on soil macroorganisms were reported. Furthermore, no chronic or long-term effects in aquatic organisms up to the water solubility limit and no acute effects for aquatic organisms above 10 mg/L were determined. In addition, an extensive elimination of the substance in sewage treatment plants, a low bioavailability and a low bioaccumulation potential is expected for the target substance. Thus, no further study on the effects on terrestrial organisms need to be conducted for Fatty acids, C16-18 (even numbered), esters with glycerol oligomers.