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Toxicity to soil microorganisms

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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 soil microorganisms.

Key value for chemical safety assessment

Additional information

No experimental data investigating the effects on soil microorganisms are available for Tetraesters of pentaerythritol with heptanoic acid and 3,5,5-trimethylhexanoic acid (List number 805-289-4). Therefore, all available related data is combined in a Weight of Evidence (WoE) approach, which is in accordance to the REACh Regulation (EC) No 1907/2006, Annex XI, 1.2, to adapt the data requirements of Regulation (EC) No 1907/2006 Annex VII - X (ECHA guidance section R.7c, R.7.11.5.3, page 134).

The substance is characterized by a high log Koc (> 5) indicating a 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, page 136 (ECHA, 2014). 

Experimental studies for the structurally similar source substances Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) and 2,2-bis[[(1-oxoisononyl)oxy]methyl]-1,3-propanediyl diisononanoate (CAS 93803-89-5) resulted in no toxicity to terrestrial macroorganisms (NOEC (56 d) ≥ 1000 mg/kg soil dw and NOEC (14 d) ≥ 1000 mg/kg soil dw, respectively).

Available reliable data for toxicity to activated sludge microorganisms support the determination of a lack of toxicity to soil microorganisms. No inhibition of activity of activated sludge microorganisms was observed in any of the available studies. 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. Since the target substance is readily biodegradable, it will be degraded quickly. This is supported by further evidence from literature data. These data show 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). Hita et al. investigated the degradation of the model molecule tristearin which is a triglyceride containing of glycerin tri-esterified with stearic acid in three different soils for 4 weeks. The amount of stearic acid increased in considerable amounts during the experiment showing the hydrolytic activity of lipases breaking the ester bonds. The investigation of ester fractions moreover showed the generation of new alkanoic acids (methyl stearate, ethyl stearate and propyl stearate) which were not determined in the controls. Nevertheless the amounts were no longer present after 4 weeks, which leads to the assumption that degradation by soil microorganisms had occurred. The same was shown by Cecutti et al. One soil sample was chosen and incubated with methyl oleate (plant oil) for 120 d. Methyl oleate and its metabolites were completely degraded after 60 d. Streptomyces coelicolor, a common gram-positive soil bacterium uses fatty acids (C4-C18) as sole carbon end energy source indicating that fatty acids are not-toxic and can be used for catabolism (Banchio and Gramajo, 1997). The available literature data shows 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.

Taking all the available information into account in a Weight of Evidence approach in accordance with Annex XI, 1.2, effects on soil microorganisms are thus not expected to be of concern, and consequently, no further testing is required.