Registration Dossier
Registration Dossier
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EC number: 272-943-8 | CAS number: 68921-51-7
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
Description of key information
No toxic effects up to the limit of water solubility (< 0.15 mg/L in aqua dest) for algae, read across
Key value for chemical safety assessment
Additional information
Since no study for assessing the toxicity to aquatic algae of 2-Butenedioic acid (E)-, di-C12-18-alkyl esters (CAS 68921-51-7) 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-C12-18-alkyl esters (CAS 68921-51-7) exhibits a molecular weight range of 453 - 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 studies with Didodecyl fumarate (CAS 2402-58-6), Ditetradecyl fumarate (CAS 10341-03-4) and -Butenedioic acid (E)-, di-C18-22-alkyl esters (CAS 68921-53-9) were conducted according to GLP and OECD guideline 201 using Desmodesmus subspicatus as test organism (Falk, 2012a, b, c). For these limit tests a loading rate of 100 mg/L and a control was performed with six replicates per treatment. As the water solubility of the test substances were below the limit of quantification of the laboratory, no monitoring of test substance concentration was performed. Between the control and the test substance treatments no significant differences in algae growth were observed in all tests. Therefore, the ErC50/ErC10 (72 h) for growth rate are determined to be > 100 mg/L (nominal) for Didodecyl fumarate (CAS 2402-58-6), Ditetradecyl fumarate (CAS 10341-03-4) and -Butenedioic acid (E)-, di-C18-22-alkyl esters (CAS 68921-53-9), respectively
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-C12-18-alkyl esters (CAS 68921-51-7).
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