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 for bioaccumulation

Additional information

Conclusion on classification

Poly [oxy(methyl-1,2-ethanediyl)] , a -hydro-w -hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 3-[[3-dimethylamino) propyl]imino]butanoate is not legally classified as dangerous for the environment and so neither included in Annex I of Directive 67/548/EEC nor in Regulation 1272/2008 (CLP), including its 2nd and 3th ATP.

According to the information summarised in this chapter, the substance should not be classified for the following reasons:

Ecotoxicity testing was performed to assess the acute toxicity to aquatic organisms of the substance under static conditions.

Since the substance hydrolyses in water, it is assumed that also hydrolysis products were generated during test media preparation and thus, the observed effects on ecotoxicity relate to both the parent substance and its hydrolysis products.

- The acute toxicity values are all above 100 mg/l representing three trophic levels obtained in short-term toxicity tests towards algae, fish and Daphnia.

- The most sensitive long-term toxicity is to algae with a 72h-NOEC of 25 mg/l.

- The substance is not readily biodegradable.

- The substance rapidly hydrolysis in water within a few minutes at ph 4 and 7. At pH 9, the half-life time is 1.9 hours.

- With regard to the logKow of the parent substance and its hydrolysis product, all values are below 3, indicating a low potential for bioaccumulation.

With the data listed above, poly [oxy(methyl-1,2-ethanediyl)] , a -hydro-w -hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 3-[[3-dimethylamino) propyl]imino]butanoate should not be classified according to DSD (Directive 67/548/EEC) and GHS (Regulation EC 1272/2008 including Commission Regulation EU-286/2011).