Fatty acids, tall-oil, esters with dipentaerythritol

Endpoint summary

Additional information

There are no data available investigating the aquatic toxicity of Fatty acids, tall oil, esters with dipentaerythritol (CAS 70913-98-3). In order to fulfil the standard information requirements, 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
Short term toxicity to fish	RA: CAS 68604-38-6	Experimental result: LL50 (96 h) > 100 mg/L
Long term toxicity to fish	Waiving based on Chemical Safety Assessment	--
Short term toxicity to aquatic invertebrates	Waiving	--
Long term toxicity to aquatic invertebrates	RA: CAS 68604-38-6	Experimental result: NOELR (21 d) ≥ 100 mg/L
Toxicity to aquatic algae	Waiving	--
Toxicity to microorganisms	RA: CAS 68604-38-6	Experimental result: NOEC (14 d) ≥ 20 mg/L

 

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). The target as well as the read-across substance both exhibit same fatty acid chain lengths C16, C18 and C18 unsatd. and the same alcohol component (dipentaerythritol) and are hexa-esters.

A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

Experimental data on the acute toxicity of the read-across substance Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS 68604-38-6) are available for fish. The short-term toxicity of the substance to zebra fish (Danio rerio) was assessed in a GLP guideline study according to OECD guideline 203 (Caduff, 2013). A LL50 (96 h) >100 mg/L and a NOEC ≥ 100 mg/L based on nominal concentrations were determined. A toxic effect of the read-across substance was therefore not observed up to the limit of water solubility. The long-term toxicity of the same read-across substance to Daphnia magna was tested in a guideline study following OECD 211 (Caduff, 2013). An effect on survival and reproduction rate of the daphnids was not observed up to the limit of water solubility (NOEC (21 d) ≥ 100 mg/L). Data on short-term toxicity to aquatic invertebrates and algae and long-term toxicity to fish are not available for Fatty acids, tall oil, esters with dipentaerythritol (CAS 70913-98-3). Nevertheless, the available acute and chronic toxicity data of the read-across substance demonstrate that toxic effects of Fatty acids, tall oil, esters with dipentaerythritol up to the limit of water solubility are not very likely. Consequently, additional acute and chronic testing is omitted. Data on the toxicity to microorganisms were used from the toxicity control of the biodegradation study according to OECD 301B (Caduff, 2012) performed with the read-across substance Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol. A respiration inhibition of activated sludge was not observed and thus the concentration of 20 mg/L of the read-across substance can be used as NOEC (NOEC (14 d) ≥ 20 mg/L).

Based on the result from a structurally related read-across substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) it can be concluded that Fatty acids, tall oil, esters with dipentaerythritol (CAS 70913-98-3) exhibits no toxic effects on freshwater organisms up to the limit of the water solubility (WS <0.04 mg/L). 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 by showing a consistent pattern of results.

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