Isobutyl laurate

Endpoint summary

Additional information

Data on the aquatic toxicity ofisobutyl laurate (CAS 37811-72-6) 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) and Fatty acids, C16-18 and C18-unsatd., iso-Bu esters (CAS 84988-79-4) 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.

Isobutyl laurate (CAS 37811-72-6) is a branched C4 alcohol esterified with a linear C12 fatty acid chain. The source substance Isopropyl myristate (CAS 110-27-0) is a branched alcohol (C3) esterified with alinear fatty acid chain (C12). Both substances are mono constituents. Whereas Fatty acids, C16-18 and C18-unsatd., iso-Bu esters (CAS 84988-79-4) is an UVCB substance comprising linear saturated and unsatured fatty acid chains (C14 – C18) esterified with a linear C4 alcohole. The read across substances cover the fatty acid chain length of the source substance as well as the characteristics of the alcohole moiety of the source substance.

Target and source substances are characterised by a low water solubility, low vapour pressure and comparable log Koc values. 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 isobutyl laurate (CAS 37811-72-6) is considered not 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, aquatic invertebrates 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 substance Fatty acids, C16-18 and C18-unsatd., iso-Bu esters (CAS 84988-79-4). The available acute toxicity test on fish, aquatic invertebrates and algae determined LC50 and EL50 values > 100 mg/L respectively.

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). Similar results were recorded in a study on the long-term toxicity of Fatty acids, C16-18 and C18-unsatd., iso-Bu esters (CAS 84988-79-4) to Daphnia magna. No mortality and detrimental effects on the reproduction were determined for the substance (NOELR (21 d) ≥ 100 mg/L).

Data on the toxicity to microorganisms are available for Isopropyl myristate (CAS 110-27-0). Adverse effects of the substances to microorganisms were not observed.

The available acute toxicity data of the read-across substances demonstrate that toxic effects of the target substance isobutyl laurate (CAS 37811-72-6) 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 isobutyl laurate (CAS 37811-72-6)will not show toxic effects on freshwater organisms up to the limit of water solubility (WS < 3 µg/L at 20 °C).