Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.012 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:
0.006 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Derivation of PNECs

The PNECs for the different compartments are calculated either by application an assessment factor (PNECfreshwater, PNECmarine water, PNECintermittent release and PNECstp) or using the equilibrium assumption method (PNECsediment-freshwater, PNECsediment-marine-water and PNECsoil). The PNECair is not considered as relevant based on the chemical structure and intrinsic properties of the registered substance. Secondary exposure of mammals and birds is not expected, and since no adequate bird or mammalian data are available, the PNECsecondary poisoning is omitted. The utilized procedures are described in detail in the ECHA REACH Guidance of May 2008, Chapter R.10 ("Characterisation of dose [concentration]-response for environment").

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 or chronically 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. Therefore classification is based on the available chronic and acute toxicity data.

- Chronic toxicity data: Chronic data are available for algae. The substance is rapidly degradable and the ErC10 (72 h) is >1 mg/L (ErC10 (72 h) 2.4 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.

Three trophic levels in aquatic toxicology are covered by acute tests. The substance is not acutely harmful to fish and invertebrates, as the LC50 (96 h) for fish and the EC50 (48 h) for daphnids were determined to be >100 mg/L and 180 mg/L respectively. Algae turned out to react most sensitive with an ErC50 of 30 mg/L after 72 hours of exposure. The ErC10 was determined to be 2.4 mg/L and the NOErC was 0.39 mg/L. 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." Therefore, the ErC10 instead of the NOErC has been used to derive the classification.

- Acute toxicity data: Fish and invertebrates are the trophic levels not covered by chronic data. Therefore classification is based on the respective acute effect data. 

The L(E)C50 are > 100 mg/L, the substance is rapidly degradable and the log Pow is < 4. Therefore the substance is not to be classified as chronically hazardous based on acute toxicity data following the criteria outlined in Table 4.1.0(b) (III).

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

 

Overall conclusion:

The substance is not to be classified as acutely or chronically hazardous to the aquatic environment according to Regulation (EC) 1272/2008.

 

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.