Registration Dossier
Registration Dossier
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EC number: 939-648-2 | CAS number: 75081-73-1
Endpoint summary
Administrative data
Description of key information
Short-term toxicity on invertebrates
EC50 19 mg/mL
Toxicity to algae
EC50 > 26 mg/mL
Short-term toxicity to fish
LC50 > 32 mg/mL
Additional information
The environmental hazard assessment for (fresh-) water organisms and sediment habitats is supported by several acute studies (pelagic compartment) and by using scientific argumentation (sediment dwelling organisms).
For the environmental hazard assessment of the registered substance acute toxicity studies for freshwater fish, daphnids, freshwater algae and STP microorganisms are available. Long-term studies for fish and daphnids are waived. Experimental information about toxicity on marine organisms is not available.
The above studies were conducted with the read across substance which was similar to the submission substance. 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. The physical chemical parameters of both substances 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.
The short-term EC50/LC50 values for fish, Daphnia and algae were >32, 19, 26 mg solid content /L. Based on the toxic control of a ready biodegradation study, no toxic effects on STP organisms were found at 50 mg/L.
The registered substance has a log Pow of << 3 resulting in a low likelihood to partition to sediment and is only moderately toxic to pelagic aquatic organisms. Therefore, the registered substance is not expected to cause adverse effects on sediment organisms. Consequently sediment toxicity tests do not need to be conducted to assess the risk for sediment-dwelling organisms.
The daphnids were the most sensitive trophic level with an acute EC50 of 19 mg solid content /L.
The chronic NOEC from a Daphnia study was 3.6 mg/L. This value will be used as worst case scenario for the risk assessment of aquatic organisms.
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