Nonanoic acid, mixed esters with heptanoic acid, pentaerythritol and valeric acid

Toxicity to terrestrial arthropods

Link to relevant study record(s)

Reference

Endpoint:

toxicity to terrestrial arthropods: long-term

Data waiving:

other justification

Justification for data waiving:

other:

Additional information

The assessment of the terrestrial toxicity should be based on the outcome of aquatic toxicity testing. Pursuant to ECHA decision on a compliance check CCH-D-2114588821-38-01/F a new long-term fish toxicity study with the registered substance will be conducted in the future. The finalised study will be reported in an updated dossier and the hazard assessment will be re-evaluated accordingly. Thus, the strategy of terrestrial toxicity will be evaluated later when the long-term fish toxicity is available.

 

In accordance with Regulation (EC) No 1907/2006, Annex IX, column 2, 9.4 further studies on the effects on terrestrial organisms do not have to be conducted since the chemical safety assessment indicates that there is no need. No experimental data on toxicity to terrestrial arthropods are available for Monopentaerythritol tetraesters and dipentaerythritol hexaesters of valeric, heptanoic and nonanoic acids. The test substance is characterised by a high log Koc (log Koc > 5) indicating a considerable potential for adsorption to soil particles. Therefore, tests with soil-dwelling organisms that feed on soil particles are most relevant for the evaluation of soil toxicity of Monopentaerythritol tetraesters and dipentaerythritol hexaesters of valeric, heptanoic and nonanoic acids. Read-across in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 from the structurally related source substances Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) and 2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6) resulted in no toxicity to terrestrial macroorganisms (NOEC (56 d) ≥ 1000 mg/kg soil dw and NOEC (14 d) ≥ 1000 mg/kg soil dw). Moreover, no acute and chronic effects were observed in the available aquatic studies. 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 (water solubility: < 2.01 mg/L; vapour pressure: < 0.0001 Pa).

Thus, the available data investigating the toxicity to terrestrial macroorganisms are sufficient to assess the hazard of Monopentaerythritol tetraesters and dipentaerythritol hexaesters of valeric, heptanoic and nonanoic acids to terrestrial organisms and no further studies are considered necessary.