Sodium 4-(2-hydroxyethyl)piperazin-1-ylethanesulphonate

Ecotoxicological Summary

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 for bioaccumulation

Additional information

Reliable experimental data on the short-term toxicity of the target substance towards aquatic invertebrates is available. The information requirements for short-term toxicity to fish, toxicity to aquatic algae and toxicity to microorganisms was covered by applying a read-across approach in accordance with Regulation (EC) No 1907/2006 (REACH) Annex XI, section 1.5 (a detailed read-across justification is attached to IUCLID section 13). Target and source substances share the same chemical structures and functional groups and have the same type of physico-chemical, toxicological and ecotoxicological effects based on common underlying mechanisms.

The non-toxicity of the read-across source and target substance, respectively, to aquatic species of three trophic levels was demonstrated in reliable guideline studies. The EC50 for aquatic invertebrates and green algae were determined to be > 100 mg/L and the NOEC for green algae was ≥ 100 mg/L. The LC50 for fish was > 100 mg/L. Based on these results the target substance is neither classified for short-term (acute) aquatic toxicity, nor for long-term (chronic) aquatic toxicity in accordance with the criteria laid down in Regulation (EC) No 1272/2008 (CLP Regulation), as last amended for the seventeenth time in Regulation (EU) 2021/849. Moreover, in compliance with the criteria of the same regulation, the target substance is not classified for physico-chemical or human health hazards. The substance is not readily biodegradable and has no potential for bioaccumulation. The log Pow of the test item was determined to be < -3.88 at 20 °C (reference 4.7-1). The target substance is hence not considered PBT or vPvB (please refer to PBT/vPvB assessment in IUCLID section 2.3). It is thus concluded, that no toxic effect to the environment or man via the environment has to be expected. Therefore, in compliance with REACH Article 14 (4), an exposure assesment is not necessary and PNECs were not derived.

Conclusion on classification

As the substance poses no hazard to aquatic organisms, and consequently not to the various environmental compartments (freshwater, marine water, STP, sediment (fresh and marine water), soil, air, predators), no classification is warranted.

 

Classification related information

Biodegradation: not readily biodegradable: -2 % (based on oxygen uptake after 28 days OECD 301 D, read-across)

Hydrolysis: t_1/2 > 1 year at 25 °C and pH 4, 7 and 9 (read-across)

Partition coefficient: log Kow = -3.88 at 20 °C

 

Aquatic acute toxicity

96 h, LC50 (Danio rerio): > 100 mg/L (nominal concentration, read-across)

48 h, EC50 (Daphnia magna): > 100 mg/L (nominal concentration)

72 h, ErC50 (Pseudokirchneriella subcapitata): > 100 mg/L (nominal concentration, read-across)

 

Aquatic chronic toxicity

72 h NOEC (Pseudokirchneriella subcapitata): ≥ 100 mg/L (nominal concentration, read-across)

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The test substance was found to be not readily biodegradable under the test conditions. In all aquatic tests the test item showed no toxic effect on the tested species. The determined EC50 for Daphnia magna and green algae were > 100 mg/L and the NOEC for green algae was ≥ 100 mg/L. The LC50 for fish was > 100 mg/L. Based on these results, the substance is neither classified as short-term (acute) aquatic toxicity nor classified as long-term (chronic) aquatic toxicity according to Regulation (EC) No 1272/2008 (CLP), as amended for the seventeenth time in Regulation (EU) 2021/849.