Lauric acid, ester with hydroxypropanediyl diacetate

Short-term toxicity to fish

Description of key information

No effects up to the limit of water solubility (OECD 203), read across.

Additional information

Since no studies investigating the short-term toxicity of Lauric acid ester with hydroxypropanediyl diacetate (CAS 30899-62-8) to fish are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substance Glycerides, C8-21 and C8-21-unsatd. mono- and di-, acetates (CAS 97593-30-1) was conducted.

The target substance is mainly characterized as a triester of glycerol esterified with acetic acid and lauric acid. A structurally very similar substance was selected as source substance. Glycerides, C8-21 and C8-21-unsatd. mono- and di-, acetates (CAS 97593-30-1) is a multi-constituent substance described as a triester of glycerol with acetic acid and lauric acid in a slightly different composition compared to the target substance. This read-across is justified in detail in the overall summary (IUCLID Section 6.1) and within the analogue justification in IUCLID Section 13. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substance was used for the assessment.

One experimental study investigating the short-term toxicity of the source substance Glycerides, C8-21 and C8-21-unsatd. mono- and di-, acetates (CAS 97593-30-1) to freshwater fish is available (Richter, 2012). The study was conducted according to EU Method C.1 (Acute Toxicity for Fish), under GLP conditions under semi-static exposure conditions. Danio rerio was exposed to the test substance at a nominal loading rate of 100 mg/L. The actual loading rate was quantified by GC analysis. GC analysis of dissolved and undissolved test solution at 100 mg/L before the final filtration step resulted in test concentrations close to nominal values. During the testing period (performed with the filtered test solutions, without the undissolved fraction), measured concentrations remained below the limit of detection (LOD) of both GC (0.070 mg/L) and DOC (2 mg/L) methods. The water solubility of the substance was tested at 100 and 1000 mg/L, resulting in values of 3.5 and 21.9 mg/L, respectively. Nevertheless, differences in solubility of substances in pure water (water solubility test) and test medium (aquatic test) can be expected. No adverse effects were observed at the concentration tested and the LL50 (96 h) was determined to be > 100 mg/L (nominal loading rate). In conclusion, no effects were observed up to the maximum achievable concentration in test medium.

Based on the available result from one structurally related source substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by a comparable structure and composition, it can be concluded that Lauric acid ester with hydroxypropanediyl diacetate will not exhibit short-term effects to fish up to the limit of water solubility.