Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

There are no data available investigating the terrestrial toxicity of Tetraesters of pentaerythritol with heptanoic acid and 3,5,5-trimethylhexanoic acid (List number 805-289-4). In order to fulfil the standard information requirements, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from a 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 terrestrial 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.

The target and all source substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information on the source substances is used to predict comparable results for the target substance Tetraesters of pentaerythritol with heptanoic acid and 3,5,5-trimethylhexanoic acid (List number 805-289-4).
The target substance is characterized as a tetraester of pentaerythritol and heptanoic acid and 3,5,5-trimethylhexanoic acid. The source substances are structurally very similar to the target substance. Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) is characterized by pentaerythritol tetra-esterified with fatty acids of C5-C10 (even and uneven numbered). The second source substance 2,2-bis[[(1-oxoisononyl)oxy]methyl]-1,3-propanediyl diisononanoate (CAS 93803-89-5) is a mono-constituent substance characterized as a tetraester of pentaerythritol and 3,5,5-trimethylhexanoic acid. A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

Exposure of the soil compartment is generally considered to be low. Even if exposed to the soil the substance is readily biodegradable indicating that it will not be persistent in the environment. Indirect exposure via irrigation or atmospheric transport is considered to be negligible based on the physico-chemical properties of the target substance (water solubility: 0.09 - 10.65 µg/L; vapour pressure: <0.0001 Pa).

Experimental data investigating the chronic toxicity of the two source substances to earthworms are available. Testing of the toxicity on earthworm evaluates the exposure to the test substance via soil pore water, surface contact as well as by ingestion of soil particles. One short-term study is available for the source substance Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9). However, due to the high adsorption potential (log Koc > 5) of the substance, long-term testing was considered to be relevant to investigate further the effects of the substance on terrestrial organisms. Thus, a chronic study with the source substance 2,2-bis[[(1-oxoisononyl)oxy]methyl]-1,3-propanediyl diisononanoate (CAS 93803-89-5) was used in addition.

The available studies were performed according to OECD 207 and OECD 222, respectively. No effects were recorded in both studies up to a concentration of 1000 mg/kg soil dw.

Since the substance is readily biodegradable it is not inhibitory to sewage sludge microbial activity. The Guidance Document (ECHA, 2014, page 136) 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 and this is clearly not the case. This is supported by further evidence from literature data. This data showed that soil microorganism communities are well capable of degrading fatty acid esters (Hita et al., 1996 and Cecutti et al., 2002) and use them as energy source (Banchio & Gramajo, 1997). Based on the available information, effects on soil microorganisms are not expected to be of concern, and consequently, no further testing is required.

In conclusion Tetraesters of pentaerythritol with heptanoic acid and 3,5,5-trimethylhexanoic acid (List number 805-289-4) is of low toxicity to terrestrial organisms based on all available data.