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Endpoint summary

Additional information

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).

In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across). Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.

The above mentioned substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information is used to predict the same endpoints for fatty acids C5-10 esters with dipentaerythritol. A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

In accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5, grouping and read-across, the target substance fatty acids C5-10 esters with dipentaerythritol and the source substances 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) are not considered to be harmful to aquatic organisms based on the experimental results from short-term studies with fish, aquatic invertebrates and algae. All substances are structurally similar and characterised by the same alcohol component (dipentaerythritol) and similar fatty acid chain lengths, respectively. Based on the structural, physico-chemical and ecotoxicological similarities, reading across between target and source substances is justified. As it can be seen in the data matrix in the Analogue Justification in IUCLID section 13 including all relevant available ecotoxicological data, none of the substances lie out of the ecotoxicological profile, showing a consistent pattern of results.

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. Both substances consist of the same alcohol component (dipentaerythritol) and similar fatty acid chain lengths (C5-9 for the target substance compared to C9iso and C5-9iso for the source substances, respectively). 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). The source substance consists of the same alcohol component (dipentaerythritol) and similar fatty acid chain lengths as the target substance (C5-9 for the target substance compared to C5-9iso for the source substances). 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). The substance consists of the same alcohol component (dipentaerythritol) and similar fatty acid chain lengths as the target substance (C5-9 for the target substance compared to C5-9iso for the source substance). 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. Both substances consist of the same alcohol component (dipentaerythritol) and similar fatty acid chain lengths as the target substance (C5-9 for the target substance compared to C9iso and C5-9iso for the source substances, respectively). 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 for an accurate assessment of the ecotoxicity profile of the target substance fatty acids C5-10 esters with dipentaerythritol.