Registration Dossier
Registration Dossier
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EC number: 453-490-7 | CAS number: -
Toxicity to soil microorganisms
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
The hazard assessment is based on the data currently available. New aquatic studies with the registered substance and/or other member substances of the polyol esters family will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available, and the hazard assessment will be re-evaluated accordingly.
There are no data available on the long-term toxicity of Fatty acids C5-10 esters with dipentaerythritol (CAS 7983-72-1) to terrestrial organisms. In order to fulfil the standard information requirements, set out in Annex VII - IX, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from one structurally related substance was conducted. A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
Long-term toxicity data on soil macroorganisms is available for the structurally and chemically closely related source substance Carboxylic acids, C5-9, hexaesters with dipentaerythritol (CAS 67762-52-1). The available study was performed according to OECD 222 and determined no effects on reproduction and mortality (NOEC (56 d) ≥ 1000 mg/kg soil dw).
Furthermore, Fatty acids C5-10 esters with dipentaerythritol shows no inhibition to activated sludge microorganisms in the available read-across studies with the structurally similar analogue substances dipentaerythritol withFatty acids, C5 and C9iso (CAS 647028-25-9) andIsononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol (CAS 84418-63-3). The applied test concentration is most likely in the range of concentrations that can be expected in the influent of a sewage treatment plant, as the substance has a very low water solubility (< 0.05 mg/L). The ECHA Guidance Document R.7c (ECHA, 2017) 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 which is clearly not the case.
Besides, no acute and chronic effects on aquatic organisms up to the water solubility limit were observed. Thus, from the aquatic toxicity tests no selective toxicity for the aquatic compartment is indicated. 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.7c (ECHA, 2017).
In addition, Fatty acids C5-10 esters with dipentaerythritol (CAS 70983-72-1) is characterised by a high log Koc (log Koc > 5, KOCWIN v2.00) indicating a considerable potential for adsorption to soil particles. Therefore, tests with soil-dwelling organisms like earthworm are preferred. The tests allow to assess exposure by a potential uptake via surface contact, by soil particle ingestion and by contact via pore water (Guidance on information requirements and chemical safety assessment, Chapter R.7c, (ECHA, 2017)). Thus, testing according to OECD 222 is considered most relevant for the evaluation of terrestrial toxicity of Fatty acids C5-10 esters with dipentaerythritol (CAS 70983-72-1).
Furthermore, the main components of the UVCB substance have high molecular weights of 759 to 1179.77 g/mol. Thus, it is unlikely that they are readily taken up by diffusion across membrane surface due to the steric hindrance of crossing biological membranes. Following the ‘rule of 5’ (Lipinski et al., 2001), developed to identify drug candidates with poor oral absorption, the substance is considered to be poorly absorbed after oral uptake based on criteria like partition coefficient (log Kow > 5) and molecular weight (> 500 g/mol). Thus, bioaccumulation potential is unlikely for Fatty acids C5-10 esters with dipentaerythritol (CAS 70983-72-1).
Overall, no further study on the effects on terrestrial organisms need to be conducted for Fatty acids C5-10 esters with dipentaerythritol (CAS 70983-72-1).
References
ECHA. 2017. Guidance on information requirements and chemical safety assessment – Chapter R.11: PBT assessment. European Chemicals Agency, Helsinki
Lipinski CA, Lombardo F, Dominy BW, Feeney PJ. 2001. Experimental and computational approaches to estimate solubility and permeability in drug discovery and development settings. Adv Drug Del Rev 46: 3–26
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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