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Long-term toxicity to aquatic invertebrates

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Description of key information

No effects up to the limit of water solubility for Daphnia magna (OECD 202, part 2)

Key value for chemical safety assessment

Additional information

Since no studies on long-term toxicity to aquatic invertebrates are available for 2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 78-16-0), the assessment of chronic toxicity was based on studies conducted with a TMP esters group member characterised by a similar fatty acid chain length, for which data is available, Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS No. 11138-60-6) as part of a read across approach. This is in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. Grouping of substance and read across approach. Further justification is given within the endpoint summary 6.1 and within the analogue justification section 13.

The available GLP study on the long-term toxicity of the read-across substance Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS No. 11138-60-6) was performed according to the OECD guideline 202 part 2 (Low, 1996). The test organism Daphnia magna was exposed to the test substance in a semi-static system for 15 days. Though the exposure time does not meet the recommended 21 days test duration for long-term tests the study is considered as valid. The requested validity criteria were fulfilled and all endpoints (e.g. survival and reproduction) could be determined. Effects on the reproduction or mobility of Daphnia magna were not observed at the tested concentrations. A NOELR of 2570 mg/L is reported. The concentration is based on the water accommodated fraction (WAF) of the substance. Due to the structural and profile similarities of the two substances, it can be concluded that toxicological long-term effects on aquatic invertebrates are not to be expected up to the limit of water solubility (< 0.05 mg/L) for 2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 78-16-0). As it can be seen in the data matrix of the category justification in section 13 and the overall endpoint summary IUCLID 6.1, all reliable data in the category support the hazard assessment of each category member by showing a consistent pattern of results, i.e. no toxic effects to aquatic organisms were observed up to the limit of water solubility.

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