Registration Dossier
Registration Dossier
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EC number: 453-490-7 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Additional information
The hazard assessment is based on the data currently available. New 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.
Only a short-term daphnia study is available investigating the aquatic toxicity of Fatty acids C5-10 esters with dipentaerythritol (CAS 70983-72-1). 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 structurally related source substances was conducted. The source substances used are Dipentaerythritol with fatty acids, C5 and C9iso (CAS 647028-25-9), Isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol (CAS 84418-63-3) and Carboxylic acids, C5-9, hexaesters with dipentaerythritol (CAS 67762-52-1). A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
Two acute toxicity studies to fish according to internationally accepted guidelines for the source substances Dipentaerythritol with fatty acids, C5 and C9iso (CAS 647028-25-9) and Isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol (CAS 84418-63-3) are available. No effects were observed up to the limit of water solubility.
According to the “Guidance on information requirements and chemical safety assessment Chapter R.7b: Endpoint specific guidance, R.7.8.5.3” (ECHA, 2017), long-term testing of fish should only be conducted if it represents the most sensitive taxonomic group. The Guidance states that if invertebrates are likely to be more sensitive than fish and algae or the relative sensitivity of invertebrates cannot be predicted, long-term testing on Daphnia sp. should be preferred instead of fish. Therefore, no long-term testing on fish is proposed.
Three studies investigating the short-term toxicity to aquatic invertebrates are available: Two with the target substance and one with the source substance Dipentaerythritol with fatty acids, C5 and C9iso (CAS 647028-25-9). No effects were observed up to the limit of water solubility, with one exception. In one of the three studies conducted with the target substance, immobilisation was observed at test concentrations of 18 mg/L, leading to EL50 (48 h) = 78 mg/L. The immobilisation was thus most likely caused by physical effects instead of systemic toxicity because a test substance film was observed and daphnids trapped on the surface. Consequently, the study was judged unreliable and was not considered for the assessment.
The results from the short-term studies are supported by an available long-term study with Daphnia magna with the source substance Carboxylic acids, C5-9, hexaesters with dipentaerythritol (CAS 67762-52-1). In this study no effects on reproduction of Daphnia magna was recorded up to a limit loading rate of 100 mg/L which significantly exceeds the water solubility of the substance.
One study with algae is available for the source substance Dipentaerythritol with fatty acids, C5 and C9iso (CAS 647028-25-9). No effects were observed up to the limit of water solubility. The toxicity to microorganisms was investigated using the toxicity control of a ready biodegradability study of the target substance. Additionally, a read across approach with the structurally similar source substances dipentaerythritol with Fatty acids, C5 and C9iso (CAS 647028-25-9) and Isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol (CAS 84418-63-3) was conducted. Based on the results and the structural and profile similarity of the substances, it can be concluded that no effect on the STP microorganism community and the subsequent degradation process in sewage treatment plants is anticipated.
In conclusion, no effects on aquatic organisms were observed in the available reliable studies for any of the three trophic levels (fish, daphnia, algae) up to the limit of water solubility.
The available data from suitable source substances allow an accurate assessment of the ecotoxicity profile of the target substance Fatty acids C5-10 esters with dipentaerythritol (CAS 70983-72-1).
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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