Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.021 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.095 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.002 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.009 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:
1.63 mg/kg soil dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
1.04 mg/kg food
Assessment factor:
90

Additional information

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

Aquatic compartment

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

Rationale:

- Acute aquatic hazard:

The substance is not to be classified as acutely hazardous to the aquatic environment, since the lowest acute effect value is > 1 mg/L (72 -h ErC50 with P.subcapitata: 9.5 mg/L; Dow Chemical, 1982).

- Long-term aquatic hazard:

Chronic data are available for algae (72-h ErC10 = 1.1 mg/L; Dow Chemical, 1982) and daphnids (21-d EC10 = 1.05 mg/L; BASF AG, 1992), but not for fish.

 

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

The classification by long-term toxicity results is based on the ErC10 values determined in the key study for algae and daphnids and not on the respective NOECs (algae: 72-h ErC10 = 1.1 mg/L, 72 -h NOEC = 0.6 mg/L; Daphnia: 21 -d EC10 = 1.05 mg/L, 21 -d NOEC = 0.78 mg/L). Both studies were recalculated using ToxRat v2.10 to obtain the EC10 effect values. 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 NOEC/EC10 is > 1.0 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 as chronically hazardous to the aquatic environment based on the available chronic data.

 

Acute toxicity data:

Fish is the trophic level not covered by chronic data. Therefore classification is based on the respective acute effect data.

With regard to the LC/EC50, the effect values show a significantly higher toxicity related to non-neutralised test solutions; therefore, the observed toxicity is partly due to the pH induced by the substance. For risk assessment the effect data for the neutralised 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 extent. It is likely that the EC50 value from the test without neutralisation overestimates the potential toxicity of the target item.

 

The 96-h LC50 for fish is 460 mg/L (not pH-adjusted). 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.