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

Toxicity to terrestrial plants

Link to relevant study record(s)

Reference

Endpoint:

toxicity to terrestrial plants: 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, 9.4, column 2, 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 plants 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 the soil particles. Due to the low water solubility (< 2.01 mg/L) only low concentrations are expected in the pore water, which is the main exposure route for terrestrial plants. Therefore, tests with soil-dwelling organisms like earthworm which allows potential uptake via surface contact, soil particle ingestion and pore water (Guidance on information requirements and chemical safety assessment, Chapter R.7c, (ECHA, 2017)) are most relevant for the evaluation of soil toxicity of Monopentaerythritol tetraesters and dipentaerythritol hexaesters of valeric, heptanoic and nonanoic acids. In addition, in the absence of a clear indication of selective toxicity, an invertebrate (earthworm or collembolan) test is preferred (Guidance on information requirements and chemical safety assessment, Chapter R.7c, ECHA, 2017). Chronic and acute data with earthworms are available 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(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6). The studies with the read-across substances resulted in a NOEC (56 d) ≥ 1000 mg/kg soil dw based on reproduction of Eisenia fetida indicating no toxicity. No higher toxicity of the test substance is expected for terrestrial plants compared to soil macroorganisms. Additionally, Monopentaerythritol tetraesters and dipentaerythritol hexaesters of valeric, heptanoic and nonanoic acids is not expected to remain in the terrestrial environment, due to ready biodegradation. In accordance with Regulation (EC) No. 1907/2006, Annex IX, Column 2, 9.4 further studies on the effects on plants do not have to be conducted since the chemical safety assessment indicates that toxicity to terrestrial plants is not expected to be of concern.