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Ecotoxicological information

Short-term toxicity to fish

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Description of key information

No toxic effects to fish up to the limit of water solubility.

Key value for chemical safety assessment

Additional information

Since no studies investigating the short-term toxicity to fish of ethane-1,2-diyl palmitate (CAS 624-03-3) are available for this endpoint, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across to the two structurally most similar category members propylene glycol diisostearate (CAS 68958-54-3) and ethylene distearate (CAS 627-83-8) was conducted. This read-across is justified in detail in the overall summary (IUCLID chapter 6.1) and within the category 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 substances were used for the assessment. Nevertheless, as it can be seen in the data matrix of the category justification in section 13 and the overall summary, all reliable data in the category support the hazard assessment of each category member by showing a consistent pattern of results.

The first study with the read-across substance 1-methyl-1,2-ethanediyl diisooctadecanoate was performed according to OECD 203 under GLP conditions with the zebrafish Danio rerio (van Egmond, 1997). Five concentrations up to 100 mg/L were tested in a semi-static exposure regime. No effects were observed after an exposure of 96 h resulting in a LC50 > 100 mg/L.

The second read-across substance ethylene distearate was tested in limit test according to the OECD Guideline 203 under GLP conditions with the rainbow trout (Oncorhynchus mykiss). A semi-static test design was chosen. No effects were observed after 96 h resulting in a LC50 of > 0.3 mg/L (nominal). 0.3 mg/L was the highest concentration which was soluble in the solubiliser tetrahydrofuran without precipitation. No mortality was observed in the control and solvent control. Based on the results from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile, it can be concluded that ethane-1,2-diyl palmitate will not exhibit acute effects to fish up to the limit of water solubility.