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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

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 a toxic control from a biodegradation test are available. A long-term daphnia study is available as read across. Long-term studies for fish 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 Butanedioic acid, sulfo-, 4-[2-[(1-oxo-10-undecenyl)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). In a bridging study with algae it was shown that Butanedioic acid, sulfo-, 4-[2-[(1-oxo-10-undecenyl)amino]ethyl] ester, disodium salt was less toxic when compared to the source substance. 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 Butanedioic acid, sulfo-, 4-[2-[(1-oxo-10-undecenyl)amino]ethyl] ester, disodium salt 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 daphnia long-term NOEC is 3 .6 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. This value will be used as worst case scenario for the risk assessment of aquatic organisms.