Registration Dossier
Registration Dossier
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EC number: 272-943-8 | CAS number: 68921-51-7
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
Description of key information
EC10 > 1000 mg/L (nominal) for respiration inhibition of activated sludge or P. putida, read across
Key value for chemical safety assessment
Additional information
Since no study for assessing the toxicity to aquatic microorganisms 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.
Activated sludge respiration inhibition tests conducted according to OECD 209 are available for the PFAE fumarates category members Ditetradecyl fumarate (CAS 10341-03-4) and 2-Butenedioic acid (E)-, di-C18-22-alkyl esters (CAS 68921-53-9). No effects were observed in concentrations well above the limit of water solubility. In addition, an oxygen consumption test according to a German national guideline (DIN 38412, part 27) is available for Didodecyl fumarate (CAS 2402-58-6), showing no effects on Pseudomonas putida as well (Kirch, 1995).
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).
The results of all three studies show distinctly, that no effects occur in the range of water solubility and well above the water solubility (i.e. EC10 > 1000 mg/L in all tests). Therefore, disturbances in sewage treatment plants are not anticipated for the members of the PFAE fumarates category.
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