Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Hazard for aquatic organisms

Hazard for air

Hazard for terrestrial organisms

Hazard for predators

Additional information

Conclusion on classification

Acute aquatic data are available for two trophic levels for the test item. The most sensitive endpoint was determined to be algae, with a 72-hour EC50 (growth rate) of 1.21 mg/L based on geometric mean measured concentration. Since the lowest EC50 value from the short-term study is > 1 mg/L, the test substance does not need to be classified for acute aquatic toxicity.

 

Chronic toxicity data are only available for algae for the substance. The lowest 72-hour NOEC for growth rate inhibition was 0.120 mg/L base on geometric mean concentrations. In situation when the chronic toxicity data are only available for one trophic level, the subsequent step is to combine two types of information, i.e. acute aquatic toxicity data and environmental fate data (degradability and bioaccumulation data) and classify according to the most stringent outcome. The lowest EC50 value from the short-term study is 1.21 mg/L based on growth rate of algae. Calcium bis[(Z)-N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate] is predicted to be readily biodegradable based on data available for the read across substance, N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3). The read across substance achieved 85.2% degradation based on CO2 evolution after 28 days, therefore it was concluded that the test item is readily biodegradable. The log Kow of Calcium bis[(Z)-N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate] was determined to be >6.2 which is above a cut-off value of log Kow ≥ 4 indicating the potential for bioaccumulation.

 

The same classification is reached based on the algal NOEC of 0.1 - 1 mg/L for a readily biodegradable substance and where the lowest EC50 is in a range of 1 - 10 mg/L, the substance is expected to be readily biodegradable, however its log Kow of ≥ 4 indicates bioaccumulation potential. Therefore, Calcium bis[(Z)-N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate] is classified Aquatic Chronic Category 2.