Fatty acids, C12-18 (even-numbered), 3-methylbutyl esters

Endpoint summary

Additional information

Data on the aquatic toxicity of Fatty acids, C12-18, even numbered, 3-methylbutyl esters (CAS 1314763-50-2) are not available.
In accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across to the structurally related substances Isopropyl myristate (CAS 110-27-0), Isopropyl palmitate (CAS 142-91-6) and Fatty acids, C8 -16, 2-ethylhexyl esters (CAS 135800-37-2) was conducted to fulfil the standard information requirements. 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). According to Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 substances can be considered to be similar if their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.

The target and the source substances are esters of a branched alcohol with a carboxylic fatty acid chain.. The fatty acid moiety of the target substance comprises linear carbon chain lengths of C12-C18 esterified with isopentanol. The source substances are C8 – C18 linear fatty acids esterified with branched C3-C8 alcohols. Target and source substances are characterised by a low water solubility, low vapour pressure and high log Koc. Thus, the substances are expected to have a similar environmental fate and ecotoxicity profile.
The available short-term and long-term studies indicate that the source substances are not acutely toxic to aquatic organisms up to the limit of water solubility.

In accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5, grouping and read-across the target substance Fatty acids, C12-18, even numbered, 3-methylbutyl esters (CAS 1314763-50-2) is not considered to be harmful to aquatic organisms based on the results of the available read across studies conducted with fish, aquatic invertebrates and algae and long-term results on toxicity to aquatic invertebrates.

Experimental data on the acute toxicity of the read-across substance Isopropyl myristate (CAS 110-27-0) are available for fish, Daphnia and algae. No toxicity of the substance was determined up to the limit of water solubility. Comparable results were determined for the second read across Isopropyl palmitate (CAS 142-91-6). The available acute toxicity test on fish and aquatic invertebrates determined L(E)C50 values >100 mg/L. The available studies on the acute toxicity of the read across substance Fatty acids, C8 -16, 2-ethylhexyl esters (CAS 135800-37-2) to aquatic algae demonstrated no toxicity of the substance.

Data on chronic toxicity are available for Isopropyl myristate (CAS 110-27-0). The long-term toxicity of the substance to Daphnia magna was tested. An effect on survival and reproduction rate of the daphnids was not observed up to the limit of water solubility (NOELR (21 d) ≥ 100 mg/L). Data on the toxicity to microorganisms are available for Isopropyl myristate (CAS 110-27-0). A growth inhibition of Pseudomonas putida was not observed.

 

The available acute toxicity data of the read-across substances demonstrate that toxic effects of the target substance Fatty acids, C12-18, even numbered, 3-methylbutyl esters (CAS 1314763-50-2) up to the limit of water solubility are not likely. Consequently, additional acute and chronic testing is omitted. Based on the result from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) it can be concluded that Fatty acids, C12-18, even numbered, 3-methylbutyl esters (CAS 1314763-50-2) will not show toxic effects on freshwater organisms up to the limit of the water solubility (WS <0.05 mg/L).