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Short-term toxicity to aquatic invertebrates

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Description of key information

EC50 (48 h) > 100 mg/l (nominal).  No effects occur in the range of water solubility and well above water solubility.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
100 mg/L

Additional information

No studies are available for the substance therefore data from studies on category substances were used for the assessement of toxicity potential to aquatic invertebrates. Read-across to the structurally related category members Didodecyl fumarate (CAS 2402 -58 -6, MW 453 g/mol), Ditetradecyl fumarate (CAS 10341-03-4, MW 509 g/mol) and 2-Butenedioic acid (E)-, di-C18-22-alkyl esters (CAS 68921-53-9, MW 621-733 g/mol) was conducted. 2-Butenedioic acid (E)-, di-C8-18-alkyl esters (CAS 68610-90-2) exhibits a molecular weight range of 340.5 - 621 g/mol. Thus, the read across is covered by interpolation for this substance. The read across is justified due to a) the structural similarity of the category members and b) similar physico-chemical properties resulting in a similar environmental fate and ecotoxicity profile. Due to the structural and physico-chemical property similarities with the tested category members Didodecyl fumarate (CAS 2402-58-6), Ditetradecyl fumarate (CAS 10341-03-4) and 2-Butenedioic acid (E)-, di-C18-22-alkyl esters (CAS 68921-53-9), this result is also applicable to read across to 2-Butenedioic acid (E)-, di-C8-18-alkyl esters (CAS 68610-90-2).

Further justification for read-across is given section 13 of IUCLID.

The study with Didodecyl fumarate (CAS 2402-58-6) was conducted according to EU method C.2 and GLP principles (Küch, 1995).The test concentrations were measured using DOC analysis; however, the analysis showed that the test substance is only poorly soluble in water and thus the measurement could not be used as basis for the determination of an effect concentration. Two tests were conducted. One test applied test concentrations of 16, 64 and 80 mg/l test prepared using a vehicle and the other test applied a 100 mg/l test solution prepared without using a vehicle. The observed undissolved test material was not removed from the treatments in test 1, but the test solution is filtered in test 2. 48 h-EC50 values of 96 mg/l (test 1 and 2a) and > 100 mg/l (test 2b) are determined for Daphnia magna on the basis of nominal concentrations. As no toxicity was observed using the filtered test solution the observed adverse effects in test 1 and 2a is expected to be related to physical interferences rather than systematic toxicity.

A study with Ditetradecyl fumarate (CAS 10341-03-4) was conducted according to OECD 202 and GLP principles (Weber, 2012). No analytical determinations were performed since the solubility of the test item is below the limit of quantification (0.04 mg/l in this test). No effects on mobility were observed in the control and at 100 mg/l in this limit test. Thus the 48 h-EC50 is assessed as > 100 mg/l.

The study with 2-Butenedioic acid (E)-, di-C18-22-alkyl esters (CAS 68921-53-9) was performed under static conditions according to GLP principles and EU method C.2 using Daphnia magna as test organism (Küch, 1995). A nominal test concentration of 100 mg/l was applied in a limit test. No immobilization was observed in any treatment and the control during the test period of 48 hours. Accordingly, the 48h-EC50 is determined to be > 100 mg/l based on nominal test concentration.

The results of all three studies show distinctly, that no effects occur in the range of water solubility and well above the water solubility.