Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Short-term aquatic toxicity studies are available for three throphic levels (fish, invertebrates and algae). Acute toxicity to fish has been investigated with two freshwater species following procedures similar to, or according to DIN 38 412, Part 15 protocol (static and flow-through) at concentrations up to 10,000 mg/l. The 96-h LC50 were reported as 4,600 (Leuciscus idus, flow through) and 4870 (Brachydanio rerio, static) mg/l, while the 48-h LC50 was reported as 2,700 (Leuciscus idus, static) mg/l. Analytical verification of concentrations were not performed in any of the studies. Based on the available data the acute toxicity to fish is very low.

Acute toxicity to aquatic invertebrate was investigated with Daphnia magna following EU procedure C.2 at a concentration of 100 mg/l. The 24 and 48 hour EC0 value was greater than 100 mg/l. Analytical verification of concentration was not performed. The available data indicates low toxicity to aquatic invertebrates.

Toxicity to algae has been tested with Desmodesmus subspicatus over a 72 hr period at concentrations from 0.5 - 100 mg/l. Effect concentration based on growth rate after 72 hrs were: EC50=150.67, LOEC=8.76 and NOEC= 4.25 mg/l. Analytical verfication of concentrations ranged from 76.9 to 130% of nominal values at 0 hours, and from 60.7 to 94% of nominal values at 72 hours.

A long-term toxicity test to aquatic invertebrates is available for the structurally related substance Ethylenediamine, ethoxylated and propoxylated: The 21d-NOEC in a OECD 211 guideline study is ≥ 10 mg/l (nominal) for all endpoints.

Toxicity to microorganisms has been tested with a sample of activated sludge (from a predominantly domestic water treatment plant) in two studies over a 3 hour period at nominal concentrations from 100 - 10000 mg/l. In one study inhibition of 12% was observed at 10'000 mg/L and the EC50 was > 10000 mg/l in the other study no effects were observed up to 700 mg/l.

In a third study, Pseudomonas putida was exposed to varying concentrations and the 17 hour EC50 was 1400 mg/l, EC10 was 800 mg/l and EC90 was 2400 mg/l, the TGK (toxicity threshold limit) comparable to the EC3 value was 800 mg/l.

As a worst case approach, the NOEC of 700 mg/L was chosen as key parameter.

Read-across statement

No-Longer-Polymer (NLP) polyether polyols are produced by the reaction of various starter molecules with propylene oxide and/or ethylene oxide. These substances exhibit a remarkable uniformity in the physical/chemical properties which influence their fate and distribution in the environment. All NLP polyols have a full acute aquatic ecotoxicity dataset and do not exhibit acute toxicity below 100 mg/L. However, differentiation in chronic invertebrate toxicity is apparent and is based on the alcohol- or amino- starter molecules used to prepare these NLP polyols. A sub-grouping based on (i) aliphatic alcohol and amine NLP polyols, (ii) EDA- (ethylenediamine) based amino NLP polyols and (iii) o-TDA- (ortho­diaminotoluene) based aromatic NLP polyols is justified (ISOPA, 2010) and toxicity is expected to be similar between substances within each of these categories. It is considered appropriate to use ‘read-across’ of data of structural analogues within each sub-grouping to fill data gaps for chronic invertebrate toxicity and derive PNECs for endpoints based on these sub-groupings