Registration Dossier
Registration Dossier
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EC number: 943-730-3 | CAS number: -
Toxicity to terrestrial plants
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to terrestrial plants: long-term
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
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 terrestrial arthropods.
Key value for chemical safety assessment
Additional information
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 2-ethylhexanoic and n-valeric 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 (1.5-5.1 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 2-ethylhexanoic and n-valeric 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 Triisononanoic acid, triester with 2,2’-[oxybis(methylene)]bis[2-(hydroxymethyl)propane-1,3-diol] tris(2-ethylhexanoate) (CAS 68443-84-5) and Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9). 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 a low toxicity. No higher toxicity of the test substance is expected for terrestrial plants compared to soil macroorganisms. 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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