Registration Dossier
Registration Dossier
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EC number: 451-190-0 | CAS number: 156558-98-4
Endpoint summary
Administrative data
Description of key information
Additional information
Currently no data are available investigating the terrestrial toxicity ofPentaerythritol tetraesters of n-C5, n-C7, n-C8, i-C9 and n-C10 fatty acids (EC 451-190-0). One study according to OECD 222 for the earthworm isstill ongoing.The dossier will be updated as soon as possible and the Chemical Safety Assessment according to Annex I of Regulation (EC) No 1907/2006 will be re-evaluated based on the outcome of the new study.
Exposure of the soil compartment is generally considered to be low. Even if exposed to the soil the substance was shown to be 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: < 1 mg/L at 25 °C; vapour pressure: 0.0062 Pa at 20 °C). However, to confirm this assumption testing with the earthworm Eisenia fetida was considered as it is a representative species of the soil fauna and thus suitable to evaluate the exposure to the test substance via soil pore water, surface contact as well as by ingestion of soil particles. Due to the high adsorption potential of the substance (log Koc > 5), long-term testing was considered to be relevant to investigate further the effects of the substance on terrestrial organisms.
Available aquatic toxicity studies with fish, invertebrates, algae and microorganisms showed no adverse effects occurred in the range of the water solubility of the substance (< 1 mg/L at 25 °C). These results obtained support the assumption that the substance is likely to show no toxicity to terrestrial organisms as well.
The available data for toxicity to activated sludge microorganisms support the determination of a lack of toxicity to soil microorganisms. No inhibition of respiration rate of a microbial sewage treatment plant community was observed in the available study according to OECD 209. The Guidance Document (ECHA, 2012, page 122) 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. This is supported by further evidence from literature data. This data showed 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). Based on the available information, effects on soil microorganisms are not expected to be of concern, and consequently, no further testing is required.
In conclusionPentaerythritol tetraesters of n-C5, n-C7, n-C8, i-C9 and n-C10 fatty acidsis of low toxicity to terrestrial organisms based on all available data. Since the dataset is not yet complete, the Chemical Safety Assessment according to Annex I of Regulation (EC) No 1907/2006 for the terrestrial compartment will be re-evaluated based on the outcome of the ongoing studies.
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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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