Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Based on the existing data on betaine, the chemical safety assessment of the substance does not indicate the need to investigate the ecotoxicological effects on terrestrial organisms. One justification is that betaine occurs in nature (plants) and is extracted from plant material (sugar beet). According to the study presented by Weibing & Rajashekar (2001) betaine is known to accumulate in a wide range of plants, typically when plants are exposed to salt and drought stress. The results also showed that glycine betaine accumulates in large quantities to test plants during water stress. The glycine betaine content is increased in Arabidopsis thaliana and other plants (i.e. barley, wheat, Puma rye) and improves the freezing tolerance of the plants during cold acclimation and water stress.

Toxicity testing on terrestrial organisms is scientifically unnecessary because betaine is not bioaccumulative and not expected to be persistent (partition coefficient Log Kow is -3.1 < 3). It is also very soluble in water, and readily biodegradable in water (mineralisation in 28 d is 88% ). According to degradation and migration studies presented by Salminen & Kalevi (2009), this substance was also rapidly biodegraded in sand soil columns. Based on these results neither betaine nor its organic degradation compounds were likely to enter groundwater. Ammonium and nitrite concentrations in soil effluent indicated that ammonium was oxidised to nitrate. This resulted in very low concentrations of ammonium and in elevated concentrations of nitrate in the soil leachates. Toxicity testing on terrestrial organisms was also considered to be scientifically unjustified because this substance is an approved fertilizer in agriculture. Betaine is a registered fertilizer product in accordance with Annex 1B 3 of the Finnish Ministry of Agriculture and Forestry regulation No 12/2007. This national legislation is based on the regulation (EC) No 2003/2003 of the European Parliament and the Council relating to fertilizers and based on the regulation (EC) no 1174/2002 of the European Parliament and the Council laying down health rules concerning animal by-products not intended for human consumption.

Exposure to terrestrial organisms was considered unlikely based on the existing data on the substance described above.