Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

According to OECD guideline tests, no adverse effects have been observed in short term studies for fish, daphnia, algae and microorganisms at the highest recommended concentrations tested. No adverse effects have been observed in a long term study for Daphnia at the highest concentration tested. This indicates that no hazard has been identified and a PNEC cannot be derived (ECHA Guidance B, Hazard assessment, August 2011).

Conclusion on classification

The substance needs not to be classified according to Directive 67/548/EEC. It is assessed to be not a PBT or vPvB. According to GHS Regulation EC No 1272/2008, formamidopropyl betaine needs not to be classified as hazardous to the aquatic environment and needs not to be classified as hazardous to the ozone layer. Therefore, according to REACH Regulation, Article 14 (4a) an exposure assessment needs not to be performed.