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Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

There are currently no data available investigating the aquatic toxicity of Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, tri- and tetraesters with pentaerythritol. In order to fulfil the standard information requirements, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted.

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 aquatic 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 target substance and all source substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information on the source substances is used to predict comparable results for the target substance Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, tri- and tetraesters with pentaerythritol.

The target substance is characterized as a tetraester of pentaerythritol and C16-C18 linear and branched/saturated and unsaturated fatty acids. The four source substances are structurally very similar to the target substance. 2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate) (CAS 62125-22-8) is a UVCB substance consisting of C18 fatty acids tetra-esterified with pentaerythritol. Fatty acids, C16-18 and C18-unsatd., tetraesters with pentaerythritol (CAS 68604-44-4) is mainly a tetraester of C16-C18 fatty acids (saturated and unsaturated) and pentaerythritol. Fatty acids, C16-18 and C18-unsatd., esters with pentaerythritol (CAS 85711-45-1) is characterized as a mono/di/tri and/or tetraester of pentaerythritol with fatty acids of C16-C18 (saturated and unsaturated). The source substance Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) is a tetraester of pentaerythritol and C5-C10 fatty acids (even and uneven numbered). A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

All experimental studies available for the suitable source substance were performed according to internationally accepted guidelines. They cover all three trophic levels of an aquatic ecosystem. No toxicity was observed up to the limit of water solubility in all available experimental studies. The water solubility of the target substance was determined to be very low with a concentration of < 5 µg/L at 20 °C, pH=6.3.

The short-term toxicity to fish was determined in standard OECD guideline studies according to OECD 203 and EU Method C.1 (from the source substance CAS 62125-22-8). No mortality was observed after 96 h resulting in a LC50 > 100 mg/L (i.e. above the water solubility limit). The same was recorded for the short-term toxicity to aquatic invertebrates and to aquatic algae. No immobilization of Daphnia magna and no inhibition of growth of aquatic algae were observed in experimental studies according to OECD guidelines up to the limit of water solubility.

Due to the low water solubility, long-term testing with aquatic invertebrates was considered to be necessary to assess the aquatic toxicity. Long-term toxicity testing with aquatic invertebrates according to OECD 211 did not result in any effects on reproduction of Daphnia magna up to the limit of water solubility. The available studies were performed with two representative source substances (CAS 85711-45-1 and CAS 71010-76-9).

Long-term toxicity testing to fish was not considered to be necessary since there was no evidence from the available data that fish are more sensitive compared to aquatic invertebrates. No toxicity to fish was observed in the available acute tests. Moreover, no chronic toxicity to aquatic invertebrates as well as aquatic algae was recorded. Thus, in order to avoid unnecessary vertebrate testing, no long-term testing with fish was proposed.

The degradation process in commercial sewage treatment plants is not suspected to be inhibited by the target substance. Results from a suitable source substance (CAS 62125-22-8) did not indicate inhibition of growth of microorganisms. 

Based on the results from structurally related source substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) it can be concluded that the target substance Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, tri- and tetraesters with pentaerythritol exhibits no toxic effects on freshwater organisms up to the limit of the water solubility. As it can be seen in the data matrix of the analogue justification in IUCLID Section 13, all reliable data from the source substances support the read-across by showing a consistent pattern of results.