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Short-term toxicity to aquatic invertebrates

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Description of key information

No effects up to the limit of water solubility (<0.05 mg/L)

Key value for chemical safety assessment

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Data on the acute toxicity of 2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 78-16-0) to aquatic invertebrates are not available. The evaluation of short-term to aquatic invertebrates refers to the group members Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS 11138-60-6) and Fatty acids, C7-8, triesters with trimethylolpropane (CAS 189120-64-7) as part of a read across approach. The read-across is suitable due to the comparable fatty acid chain length of the substances. 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 studies on the read-across substances Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS 11138-60-6) and Fatty acids, C7-8, triesters with trimethylolpropane (CAS 189120-64-7) were conducted according to OECD guideline 202 (Davi, 2000, Häner, 2007). In both studies Daphnia magna were exposed to the test substances in a static test system for 48 hours. The water accommodated fraction (WAF) of the test substances was used for the preparation of test solutions. In the limit test on Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS 11138-60-6) an EL 50 > 100 mg/L based on the WAF (loading rate) was determined. For Fatty acids, C7-8, triesters with trimethylolpropane (CAS 189120-64-7) an EC50 of 0.59 mg/L based on the measured substance concentration was determined. The reported NOELR was ≥ 1000 mg/L (nominal). Thus, no effects were observed up to the water solubility of the test substances (< 0.1 mg/L).

Based on the results from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterised by a similar ecotoxicological profile, acute toxic effects of 2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 78-16-0) to aquatic invertebrates are not expected.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.