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Endpoint summary

Additional information

There are no data available for the long-term toxicity of fatty acids C5-10 esters with dipentaerythritol (CAS 7983-72-1). In order to fulfil the standard information requirements set out in Annex VII - IX, 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 human 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, environmental fate, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.

Ecotoxicological parameters for the terrestrial toxicity of the target substance fatty acids C5-10 esters with dipentaerythritol (CAS 70983-72-1) and the source substances are presented in the following table.

	Target	Source 3
CAS	70983-72-1	67762-52-1
Chemical Name	Fatty acids C5-10 esters with dipentaerythritol	Carboxylic acids, C5-9, hexaesters with dipentaerythritol
MW	759-1179	759 - 1095
Fatty acid chain length	C7-10	C5-9
Alcohol	dipentaerythritol	dipentaerythritol
Toxicity to soil macroorganisms	RA: CAS 67762-52-1	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 C5-10 esters with dipentaerythritol.

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

In accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5, grouping and read-across, the target substance fatty acids C5-10 esters with dipentaerythritol and the source substance carboxylic acids, C5-9, hexaesters with dipentaerythritol (CAS 67762-52-1) are not considered to be harmful to terrestrial organisms based on the results from long-term study with earthworm.

Both substances are structurally similar characterised by the same alcohol component (dipentaerythritol) and similar fatty acid chain lengths, respectively.

Based on the structural, physico-chemical and ecotoxicological similarities, reading across between target and source substances is justified. As it can be seen in the data matrix including all relevant available ecotoxicological data, none of the substances lie out of the ecotoxicological profile, showing a consistent pattern of results.

The toxicity of the source substance carboxylic acids, C5-9, hexaesters with dipentaerythritol (CAS 67762-52-1)to terrestrial organisms was tested in one available long-term toxicity test on earthworms. Eisenia fetida was exposed to the substance in artificial soil according the specifications given in OECD guideline 222 under GLP conditions (Eisner, 2013). Nominal concentrations of 62.5, 125, 250, 500 and 1000 mg/kg dw were tested. 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 (56 d) ≥ 1000 mg/kg was determined based on reproduction. Studies on other terrestrial organisms are not available but a toxicity of the substance to terrestrial organisms is considered to be unlikely.

The test substance is characterized by a log Koc > 5 indicating a high potential for adsorption to soil particles. Tests with soil-dwelling organisms that feed on soil particles are therefore most relevant for the evaluation of soil toxicity. In the absence of a clear indication of selective toxicity, an invertebrate (earthworm or collembolan) test is preferred, as outlined in ECHA guidance section R.7.11.5.3 (ECHA, 2012). Chronic soil macroorganism data are available resulting in no effects on reproduction for earthworms were observed (NOEC (56 d) ≥ 1000 mg/kg soil dw). Due to the low water solubility (< 0.05 mg/L), only low concentrations are expected in the pore water, which is the main exposure route for terrestrial plants.Since the pore water is the main route of uptake for terrestrial plants, the bioavailability of the substance is presumably low. An uptake of the substance by plant roots is also hindered by the high molecular weight of the substance (759 – 1095 g/mol) preventing the substance from crossing biological membranes. Therefore, tests with soil-dwelling organisms like earthworm which allows potential uptake via surface contact, soil particle ingestion and porewater (ECHA, 2012), are most relevant for the evaluation of terrestrial toxicity. In addition, in the absence of a clear indication of selective toxicity, an invertebrate (earthworm or collembolan) test is preferred, as outlined in ECHA guidance section R.7.11.5.3, page 122.

Moreover, the target substance fatty acids C5-10 esters with dipentaerythritol shows no inhibition to aquatic microorganisms in the read across with structurally similar analogue substances dipentaerythritol with fatty acids, C5 and C9iso (CAS 647028-25-9) and isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol (CAS 84418-63-3). The applied test concentration is most likely in the range of concentrations that can be expected in the influent of a sewage treatment plant, as the substance has low water solubility (< 0.05 mg/L). The ECHA Guidance Document R.7c (ECHA, 2012) states that a test on soil microbial activity will only be additionally necessary for a valid PNEC derivation if inhibition of sewage sludge microbial activity has occurred. Therefore, toxicity to soil microorganisms is considered to be unlikely.

The available data are sufficient for an accurate hazard assessment of the terrestrial compartment. The Chemical Safety Assessment according to Annex I of Regulation (EC) No. 1907/2006 does not indicate the need to perform further studies on the effects on terrestrial organisms.