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Short-term toxicity to fish

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Description of key information

96 h LC50: 32 mg/L

Key value for chemical safety assessment

LC50 for freshwater fish:
32 mg/L

Additional information

In the Klimisch 2 GLP study from Kimmel (2013) the acute toxicity of Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts to zebra fish (Danio rerio) was determined in a 96‑hour semi-static test with daily test medium renewal according to the EU Commission Directive 92/69/, Part C.1, the Commission Regulation (EC) No 440/2008, Part C.1 and the OECD Guideline for Testing of Chemicals No. 203 (1992). The following nominal concentrations of Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts were tested: 0.76, 2.4, 7.6, 24 and 76 mg test item/L corresponding to 0.32, 1.0, 3.2, 10 and 32 mg solid content/L. Additionally, a control (test water without test item) was tested in parallel. The measured concentrations of the 32 mg solid content/L was within 94 and 101 % of the nominal concentrations. Consequently, the biological results are related to the nominal test item concentrations.

In the control and up to and including the highest test concentration 32 mg solid content/L, all fish survived until the end of the test and no visible abnormalities were observed. The 96 hour NOEC and LC0 of Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts to zebra fish were both determined to be 32 mg solid content/L. The 96 hour LC50was determined to be > 32 mg solid content/L.

 

For C12 -MEA (Butanedioic acid, 2(or 3)-sulfo-, 4 -[2 -[(1 -oxododecyl)amino]ethyl] ester, disodium salt)read across was made from the source chemical C12-C18/C18'-MEA (Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12 -C18(even numbered) and C18 unsaturated)alkyl))amino]ethyl]esters, disodium salts). Both substances have the same main C-Chain length of C12 (C12-MEA 75 -90% C12, C12-C18/C18'-MEA 45 -55%) . In C12-MEA the C14 alkyl rest is represented with < 10% while in C12 -C18/C18'-MEA C14 comprises to 15 -20%. This difference is considered small. It can be argued that C12 -MEA is already part of C12 -C18/C18'-MEA. As mentioned before, the physical chemical parameters are similar. Within the N2 subgroup, the toxicity does not show a clear C-Chain dependency, i.e., the EC50/LC50 data for all members of this group are similar. Therefore, read across from C12 -C18/C18'-MEA (source) to C12 -MEA is considered as being justified.

Based on the data set and the supporting evidence for read across including the similarity of the C-Chain distribution, no further risk assessment factor is needed.The results of this study are considered relevant and reliable for the risk assessment.