Registration Dossier
Registration Dossier
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EC number: 272-944-3 | CAS number: 68921-52-8
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
No toxic effects up to the limit of water solubility (< 0.05 mg/L in aqua dest) for fish, read across
Key value for chemical safety assessment
Additional information
As no study for assessing the acute toxicity to fish of 2-Butenedioic acid (E)-, di-C16-18-alkyl esters (CAS 68921-52-8) is available, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 Grouping of substances, a 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-C16-18-alkyl esters (CAS 68921-52-8) exhibits a molecular weight range of 565 - 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.
Further justification is given within the endpoint summary 6.1 and within the category justification section 13.
The study with Didodecyl fumarate (CAS 2402-58-6) was conducted according to GLP and EU method C.1 under semi-static conditions (Scholz, 1995). A 96 h-LC50 value of 2200 mg/L was determined for Danio rerio on the basis of nominal test concentrations.
A study with Ditetradecyl fumarate (CAS 10341-03-4) was conducted according to GLP and OECD 203 (limit test) using Danio rerio as test organism (Wiech, 2012). No analytical determinations were performed since the solubility of the test item is below the limit of quantification (0.04 mg/L). No sub-lethal or lethal effects were observed in the control and at 100 mg/L. Thus the 96 h-LC50 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 semi-static conditions according to GLP and EU method C.1 using Brachydanio rerio as test organism (Scholz, 1995). Concentrations of 1000, 3000 and 10000 mg/L test material were directly added to the test vessels. No mortality was observed in any treatment and the control during the test duration of 96 hours. Accordingly, the 96 h-LC50 is determined to be > 10000 mg/L.
The results of all three studies show distinctly, that no effects occur in the range of water solubility and well above the water solubility.
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), these results are also applicable to read across 2-Butenedioic acid (E)-, di-C16-18-alkyl esters (CAS 68921-52-8).
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