2-octyldodecyl 12-[(1-oxooctadecyl)oxy]octadecanoate

Endpoint summary

Additional information

There are no data available for the aquatic toxicity of 2-octyldodecyl 12-[(1-oxooctadecyl)oxy]octadecanoate (CAS 90052-75-8). Therefore, the aquatic toxicity of the target substance was assessed by a read-across approach to the four structurally and chemically closely related substances 2-octyldodecyl isooctadecanoate (CAS 93803-87-3), 9-Octadecenoic acid (9Z)-, decyl ester (CAS 3687-46-5), Lauryl Oleate (dodecyl oleate) (CAS 36078-10-1), (Z)-octadec-9-enyl oleate (CAS 3687-45-4), and Isohexadecyl 12-[(1-oxooctadecyl)oxy]octadecanoate (CAS 97338-28-8) in order to fulfill the standard information requirements laid down in Regulation (EC) No 1907/2006. Read-across was performed in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5.

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.” For aquatic toxicity in particular, 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.

Based on the high degree of structural similarity as well as similar physico-chemical properties of the target and selected source substances, the target substance is expected to have a similar ecotoxicological profile as the selected source substances. 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 short-term and long-term aquatic toxicity of the target substance 2-octyldodecyl 12-[(1-oxooctadecyl)oxy]octadecanoate (CAS 90052-75-8) to all three trophic levels.

The compiled data for acute toxicity to fish and aquatic algae as well as the chronic toxicity to aquatic algae neither indicate any short-term nor long-term toxicity up to the limit of water solubility of the source substances. The available long-term study on aquatic invertebrates, in which a limit test was performed according to OECD guideline 211, indicates long-term effects on the reproduction of aquatic invertebrates. After 21 d, the reproductive performance (mean offspring per parent animal) was significantly reduced by 58.5% at the limit concentration, resulting in a NOEC (21 d) for reproduction of < 7.0 µg/L (nominal). Furthermore, no toxic effects towards microorganisms of activated sludge were recorded.

Due to ready biodegradability and high adsorption potential, the target substance is expected to be eliminated from sewage treatment plants to a high extent. Release to surface waters and subsequent exposure of sediment is therefore very unlikely. In the unexpected case where absorption by aquatic organisms should occur, the substance is expected to be rapidly metabolized via enzymatic hydrolysis into its corresponding fatty acids and fatty alcohols, which are known from literature to metabolize well in aquatic organisms. Against this background, the potential for chronic exposure and for bioaccumulation in aquatic organisms is judged to be very low.

Therefore, it is concluded that the target substance 2-octyldodecyl 12-[(1-oxooctadecyl)oxy]octadecanoate (CAS 90052-75-8) does not exhibit short-term effects to aquatic organisms up to the limit of water solubility (< 0.05 mg/L), does not negatively affect the degradation process in sewage treatment plants but may cause long-term effects in aquatic organisms.