Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Terrestrial toxicity

In Annex X Section 9.4 of Regulation (EC) No 1907/2006, it is laid down that tests on terrestrial organisms shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on terrestrial organisms. According to Annex IX and X, the choice of the appropriate tests depends on the outcome of the chemical safety assessment.

According to Annex I of this regulation, the chemical safety assessment triggers further action when the substance or the preparation meets the criteria for classification as dangerous according to Directive 67/548/EEC or Regulation EC 1272/2008 or is assessed to be a PBT or vPvB.  

The hazard assessment of the substance reveals neither a need to classify the substance as dangerous to the environment, nor is it a PBT or vPvB substance, nor are there any further indications that the substance may be hazardous to the environment. In addition, indirect exposure to the soil compartment is unlikely since the substance is readily biodegradable according to OECD criteria (see IUCLID Ch. 5.2.1). For substances being considered as „readily biodegradable“, it can be assumed that they will be biologically degraded within the STP-process. As the log Koc and log Kow of the substance are below 3, a low adsorption potential is indicated (see IUCLID Ch. 5.4.1). Hence, an adsorption to activated sludge is unlikely. Based on the low log Kow and the low estimated BCF values, bioaccumulation in aquatic organisms is not to be expected (see IUCLID Ch. 5.3.1).  

In Annex XI Section 3, it is laid down that testing in accordance with sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX and Annex X may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report (“Substance-Tailored Exposure-Driven Testing”). In accordance with Annex XI Section 3, it can be demonstrated in the risk assessment that the manufacture and the use of the substance do not pose an unacceptable risk for all environmental compartments as the risk characterization ratios (RCRs) of the chemical safety assessment are below 1 for all compartments (see Chemical Safety Report Ch. 10).  

Consequently, no tests on soil organisms are required. However, long-term toxicity studies are availabel for earthworms, collembolans and terrestrial plants. However, as these studies did not report chronic effect values (EC10, NOEC), the PNECs were derived using the EC50 values as acute data.

Bergmann et al. (1990, 1991) published information on the effects of MEA to plants. The exposure of plants to MEA resulted in a stimulating effect. Negative effects were not observed.

In a report by Stantec (2006), long-term effects of MEA on earthworms, collembolans and plants were studied according to guidelines by Environment Canada. Only EC25 and EC50 were reported; therefore, the results are evaluated as acute effects. All EC25 and EC50 values were greater than 1000 mg/kg soil dw, which is the normally applied highest test concentration.

The PNEC soil will be derived based on experimental data only according to REACH Guidance R.10.6.2 as short-term data are available for producer, consumer, and decomposer.

Using this PNECsoil, the risk characterization revealed that the PEC/PNECsoil ratio (RCRsoil) is <1, indicating no need for further information and testing.

Toxicity to birds

No studies on the toxicity to birds are available for the substance.  

In Annex X Section 9.6.1 of Regulation (EC) No 1907/2006, it is laid down that any need for testing should be carefully considered taking into account the large mammalian dataset that is usually available at this tonnage level. In case of 2-aminoethanol (MEA, CAS 141-43-5), a mammalian dataset is available. In addition, the hazard assessment of the substance reveals neither a need to classify the substance as dangerous to the environment, nor is it a PBT or vPvB substance, nor are there any further indications that the substance may be hazardous to the environment. In addition, indirect exposure to the soil compartment is unlikely since the substance is readily biodegradable according to OECD criteria. For substances being considered as „readily biodegradable“, it can be assumed that they will be biologically degraded within the STP-process (see IUCLID Ch. 5.2.1). Based on the low log Kow and the low estimated BCF values, significant bioaccumulation in organisms is not to be expected (see IUCLID Ch. 5.3.1).  Hence, secondary poisoning is of no concern.

In Annex XI Section 3, it is laid down that testing in accordance with sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report (“Substance-Tailored Exposure-Driven Testing”). In accordance with Annex XI Section 3, it can be demonstrated in the risk assessment that the manufacture and the use of the substance do not pose an unacceptable risk for all environmental compartments as the risk characterization ratios (RCRs) of the chemical safety assessment are below 1 for all compartments (see Chemical Safety Report Ch. 10).

Therefore, and for reasons of animal welfare, no tests on birds are performed.