Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

The substance possess low acute toxicity to invertebrates ( D.magna) EC50 (48 h) 4335 mg/l and to algae ( D. subspicatus) EC50 (72 h) 1199 mg/l. Aquatic toxicity to algae was also determined as EC10 -value (120 mg/l). Studies were carried out by using OECD methods 201 and 202 in accordance with the GLP practice.

The field data of the manufacturer's waste water treatment plant (WWTP) also indicate that this substance is not toxic to activated sludge micro-organisms. Waste waters resulting from the manufacturing process of this substance are treated in the low-rate activated sludge treatment plant at the manufacturing site. The treatment plant is continuously monitored, and the operation of the WWTP is covered by an environmental permit. Based on the annual monitoring results, betaine at average influent concentrations of 0.079 g/l is not an inhibitory to activated sludge micro-organisms. Nitrogen present in the substance can be efficiently removed during the treatment process. The removal efficiencies are 93% for total nitrogen and 95% for ammonium, respectively.

Based on the physico-chemical properties, betaine is not bioaccumulative and not expected to be persistent because the octanol-water partition coefficient of the substance is low (Log Pow is -3.1). It is readily biodegradable in water (mineralisation in 28 d is 88% ) based on the screening test OECD 301B. Also the BOD:COD -ratio (ratio 1) indicates ready biodegradability. The ratio was calculated by using analysed BOD -values and theoretical COD calculations.

Based on the existing data, the chemical safety assessment of the substance does not indicate the need to investigate the short-term effects on fish or STP microorganisms, nor the long-term effects on fish or invertebrates. Based on the fate and pathways of the substance also exposure to sediment organisms was considered unlikely. The existing data on the substance was regarded as conclusive but not sufficient for the classification of the substance with regard to acute or chronic aquatic toxicity.