Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
112.9 mg/L
Assessment factor:
1
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.5 mg/kg sediment dw
Extrapolation method:
sensitivity distribution

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.05 mg/kg sediment dw
Extrapolation method:
sensitivity distribution

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.09 mg/kg soil dw
Extrapolation method:
sensitivity distribution

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 and PNECsecondary poisoning are not considered as relevant based on the chemical structure and intrinsic properties of the registered substance.

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").

Environmental classification and labeling

Experimental and reliable QSAR-based results are available for evaluating biodegradation, metabolism and toxicity of Choline chloride towards aquatic vertebrate and invertebrate species. Beside acute toxicity data for three trophic levels (i.e. fish, daphnids and algae), also adequate long-term data are available (i.e. daphnids and algae). Choline chloride was found to be rapidly biodegradable (BASF AG, 1984) and based on the logPow of -3.77 (BASF AG, 1988) and BCF of 3.16 L/kg (Chemservice S.A., 2018b), no bioaccumulation in aquatic organisms is expected. The test substance was found to be not acutely toxic at concentrations upon 500 mg/L or even higher (for details, please refer to the different studies conducted by BASF AG). The most critical NOEC(21d) was found as 30.2 mg/L in an experiment conducted according to OECD 211 with Daphnia magna (MOE Japan, 1999). Based upon these results and in reference to Regulation (EC) No 1272/2008, Choline chloride has not to be classified and labelled with respect to environmental hazards.

Conclusion on classification

In accordance to Regulation (EC) No. 1272/2008 (Classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No. 1907/2006), Choline chloride has not to be classified and labelled with respect to environmental hazards.