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There are no data available for the aquatic toxicity of Fatty acids, C16 and C18-22 - unsatd., C16-18 and C18 unsatd. alkyl ester (CAS 90990-29-7). Therefore, the aquatic hazard of the target substance was assessed by a read-across approach to two structurally and chemically related substances in order to fulfill the standard information requirements laid down by Annex XI, 1.5, of the REACH Regulation (EC) No 1907/2006.

According to Article 13 (1) of this 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). In 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.

 

Both source substances are characterized by fatty acids and fatty alcohols of similar chain lengths as the target substance, and are therefore considered suitable representatives for the assessment of the long-term toxicity of the target substance to aquatic invertebrates. The target substance consists of several fatty acid esters composed of fatty acids of chain lengths C16 and C18 – 22 (unsaturated) and fatty alcohols of chain lengths C16-18 (unsaturated). The source substance dodecyl oleate (CAS 36078-10-1) is characterized by a fatty alcohol and fatty acid with carbon atom chain lengths of C12 and C18, respectively. The source substance (Z)-octadec-9-enyl oleate (CAS 3687-45-4) consists of a fatty alcohol and fatty acid of a carbon atom chain length of C18 each. A detailed analogue approach justification is provided in IUCLID section 13 of the technical dossier.

 

By means of the read-across approach GLP guideline studies are available for the assessment of the aquatic toxicity of the target substance Fatty acids, C16 and C18-22 - unsatd., C16-18 and C18 unsatd. alkyl ester (CAS 90990-29-7) to two trophic levels (aquatic invertebrates and microalgae). The compiled data indicate neither short-term nor long-term toxicity towards aquatic freshwater organisms up to the limit of the water solubility of the source substances.

Therefore, it can be concluded that Fatty acids, C16 and C18-22 - unsatd., C16-18 and C18 unsatd. alkyl ester (CAS 90990-29-7) will not exhibit short-term or long-term effects to aquatic organisms up to the limit of water solubility (< 0.05 mg/L at 20 °C).