Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.062 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.34 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.006 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.673 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.067 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.098 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Additional data attached (Section 13)

Conclusion on classification

Official classification regarding environmental hazards

Aquatic compartment

According to Regulation (EC) 1272/2008 Annex VI Table 3.1, the substance is not classified as hazardous to the environment.

According to Regulation (EC) 1272/2008 Annex VI Table 3.2, the substance is not classified as hazardous to the environment.

 

Self-classification

Following GHS, the substance is not to be classified as acutely hazardous to the aquatic environment. Based on the available acute and chronic data, the substance is not to be classified as hazardous to the aquatic environment.

Rationale:

The substance is not to be classified as acutely hazardous to the aquatic environment, since the lowest acute effect value is > 1 mg/L.

Chronic data are available only for algae, but not for fish and daphnids. Therefore classification is based on the available chronic and acute toxicity data.

 

- Chronic toxicity data:

Chronic data are available for freshwater algae (72-h ErC10= 21.4 mg/L, re-calculated with Toxrat v2.10; originally reported value: 72-h NOErC= 10 mg/L; Oekolimna, 1988).

Remark on the classification assessment by long-term toxicity data:

Classification by long-term toxicity results is based on the 72-h ErC10 of 21.4 mg/L determined in the key study for algae (recalculated with ToxRat v2.10). According to the Guidance on information requirements and chemical safety assessment Chapter R.10: Characterisation of dose [concentration]-response for environment ", an EC10 for a long-term test which is obtained using an appropriate statistical method (usually regression analysis) will be used preferentially. [...] There has been a recommendation within OECD in 1996 to phase out the use of the NOEC, in particular as it can correspond to large and potentially biologically important magnitudes of effect. The advantage of regression method for the estimation of ECx is that information from the whole concentration-effect relationship is taken into account and that confidence intervals can be calculated. These methods result in an ECx, where x is a low effect percentile (e.g. 5-20%). It makes results from different experiments more comparable than NOECs".

The substance is rapidly degradable and the ErC10 is > 1 mg/L. According to the criteria outlined in Table 4.1.0(b) (ii) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008) the substance is not to be classified based on the available chronic data.

 

- Acute toxicity data:

Fish and daphnids are the trophic levels not covered by chronic data. Therefore classification is based on the respective acute effect data.

Remark on the classification assessment by short-term toxicity data:

With regard to the LC/EC50, the effect values show a significantly higher toxicity related to non-neutralized test solutions; therefore, the observed toxicity is partly due to the pH induced by the substance. For risk assessment the effect data for the neutralized test medium should be used, since the quantities of 2-diethylaminoethanol that would be found in natural waters are not likely to affect the pH to a relevant extend. It is likely that the EC50 value from the test without neutralization overestimates the potential toxicity of the target item.

The 96-h LC50 (neutralized) for fish is > 1000 mg/L; for daphnids, the 48-h EC50 (neutralized) is > 100 mg/L. Moreover, the substance is rapidly degradable. Therefore the substance is not to be classified as chronically hazardous based on acute toxicity data.

 

Conclusion: the substance is not to be classified as chronically hazardous to the aquatic environment.

 

Atmospheric compartment

The test substance is not in Annex I of Regulation (EC) 2037/2000 on substances that deplete the ozone layer.

The test substance does not belong to the greenhouse gases listed in P Forster, PV Ramaswamy et al. Changes in Atmospheric Constituents and in Radiative Forcing. In: Climate Change 2007: The Physical Basis. Contribution of Working Group I to the Fourth Assessment Report of the Intergovernmental Panel on Climate Change.