Fatty acids, tall-oil, esters with dipentaerythritol

Endpoint summary

Additional information

There are no data available investigating the terrestrial toxicity of Fatty acids, tall oil, esters with dipentaerythritol (CAS 70913-98-3). In order to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from one structurally related substance 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.” In particular for aquatic toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).

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.

Ecotoxicological parameters for the aquatic toxicity of the target and the source substance are provided in the following table.

CAS	70913-98-3	68604-38-6
Chemical Name	Fatty acids, tall oil, esters with dipentaerythritol	Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol
MW	1684.73 - 1840.95	1684.73 - 1840.95
Toxicity to soil macroorganisms except arthropods	RA: CAS 68604-38-6	NOEC (56 d) ≥ 1000 mg/kg dw
Toxicity to terrestrial arthropods	Waiving	--
Toxicity to terrestrial plants	Waiving	--
Toxicity to soil microorganisms	Waiving	--

 

The above mentioned substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information is used to predict the same endpoints for Fatty acids, tall oil, esters with dipentaerythritol (CAS 70913-98-3). A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

 

Since no studies investigating the toxicity to terrestrial organisms of Fatty acids, tall oil, esters with dipentaerythritol (CAS 70913-98-3) are available, a read across to a structurally related substance Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS 68604-38-6) was conducted in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5. The target as well as the read-across substance are both characterised by the same fatty acid chain lengths C16, C18 and C18 unsatd. and the same alcohol component (dipentaerythritol) and are hexa-esters.

The toxicity of the read-across substance Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS 68604-38-6) to terrestrial organisms was tested in a long-term toxicity test on earthworms. Eisenia fetida was exposed to the substance in artificial soil according to OECD 222 (Hernádi, 2013). The mortality and growth of adult earthworms was assessed after 28 days and the reproduction rate after 56 days. Adverse effects of the substance were not observed and therefore a NOEC (56 d) ≥ 1000 mg/kg dw soil was determined. Studies on other terrestrial organisms are not available for Fatty acids, tall oil, esters with dipentaerythritol (CAS 70913-98-3) but a toxicity of the substance to terrestrial organisms is considered as unlikely. Due to the low water solubility (<0.04 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 microorganisms. As a result of 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)). Nevertheless, if terrestrial organisms are exposed to the substance toxic effects are not expected as demonstrated by the available data on the acute and chronic toxicity to aquatic and terrestrial organisms. An ingestion of the substance via food particles might be possible due to the high adsorption potential. But as a result of metabolism via enzymatic hydrolysis of the substance relevant absorption and bioaccumulation is not expected. The part of Fatty acids, tall oil, esters with dipentaerythritol (CAS 70913-98-3) 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, tall oil, esters with dipentaerythritol (CAS 70913-98-3) 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 of the CSR. In summary, the substance is unlikely to pose a risk for terrestrial organisms based on 1) the lack of exposure and 2) the low toxicity of the substance for terrestrial organisms indicated by the available experimental data, metabolism considerations and the lack of adverse effects in aquatic ecotoxicity tests. As it can be seen in the data matrix of the analogue justification in IUCLID Section 13, all reliable data from the target and the source substance support the read-across for the endpoint long-term toxicity to aquatic invertebrates by showing a consistent pattern of results.

 

References

ECHA. 2012. Guidance on information requirements and chemical safety assessment – Chapter 7a: Endpoint specific guidance.European Chemicals Agency, Helsinki.