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Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

The dataset for the aquatic toxicity of the target substanceMonoesters of C16 and C18 (branched and linear) fatty acids with decan-1-olis not complete. Therefore, the aquatic hazard profile of the target substance was completed by a read-across approach to structurally and chemically closely related source substances according to Annex XI (1.5) of the REACH regulation (EC) 1907/2006 in order to fill the missing data gaps and meet the standard information requirements laid down by the Regulation, Annex VIII.

According to Article 13 (1) of the Regulation, "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). With regard to the general rules for grouping of substances and the read-across approach, the regulation specifies (Annex XI, Item 1.5) that 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 substanceMonoesters of C16 and C18 (branched and linear) fatty acids with decan-1-olis a UVCB substance, consisting of a mixture of related esters resulting from the esterification of branched and linear fatty acids with a chain length of 16 and 18 carbon atoms and the unbranched fatty alcohol decanol with a carbon chain length of 10. The source substance dodecyl oleate (CAS 36078-10-1, C30 H58 O2) is also a UVCB substance predominantly composed of esters of the mono-unsaturated, linear oleic acid with a carbon chain length of 18 (C18:1) and the linear fatty alcohol dodecanol with a carbon chain length of 12. The source substance 2-ethylhexyl oleate (CAS 26399-02-0, C26 H50 O2) is a mono-constituent substance predominantly composed of esters of the fatty acid oleic acid with a carbon chain length of 18 (C18:1) and the branched alcohol 2-ethylhexanol with a carbon chain length of 8. Thus, target substance properties will be predicted by interpolation from source substance data. Based on the high degree of similarity between the structural and physico-chemical properties of the target and the source substances, the target substance is expected to have a similar ecotoxicity profile as the source substances. Therefore, the selected source substances are considered to be suitable representatives for the assessment of the aquatic toxicity profile of the target substance. A detailed analogue approach justification is provided in the technical dossier (IUCLID, section 13).

 

To complete the data set for the aquatic toxicity of the target substance, the read-across approach was applied to predict the short-term toxicity to fish and the long-term toxicity to aquatic invertebrates. In doing so, GLP guideline studies are available for all three trophic levels (fish, aquatic invertebrates and algae) for the assessment of the aquatic toxicity of the target substanceMonoesters of C16 and C18 (branched and linear) fatty acids with decan-1-ol.

The aquatic toxicity data compiled in this way for the short-term aquatic toxicity (fish, aquatic invertebrates and algae) and the long-term aquatic toxicity (aquatic invertebrates and algae) neither indicate any short-term nor any long-term toxicity towards aquatic freshwater organisms up to the limit of water solubility. Furthermore, no toxicity towards aquatic microorganisms of activated sludge was recorded.

Therefore, it is concluded that the target substanceMonoesters of C16 and C18 (branched and linear) fatty acids with decan-1-oldoes not cause short-term or long-term toxicity to aquatic organisms up to the limit of water solubility (0.16 mg/L) and does not adversely affect the degradation process in commercial sewage treatment plants.