Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
0.086 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 the read-across substance Choline chloride (CAS 67-48-1) towards aquatic vertebrate and invertebrate species. Choline chloride belongs, like the target substance Choline hydrogen carbonate, to the group of quaternary amine salts (more specific: choline salts, i.e. (2-hydroxyethyl)trimethylammonium salts), which will dissociate immediately in aqueous environment. Choline and its metabolites are important for different functions in the body of animate beings and thus a naturally occurring compound. Thus, the substance characteristics of both substances are comparable. For the detailed justification of this procedure, please refer to the separate read-across statement by Chemservice S.A. (2013).

Beside acute toxicity data for three trophic levels (i.e. fish, daphnids and algae), also adequate long-term data are available (using daphnids as test species). Choline hydrogen carbonate can be considered as rapidly biodegradable (based on an experimental result from Choline chloride (CAS 67-48-1; BASF AG, 1984) and the read-across 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 reliable and valid results and in reference to Regulation (EC) No. 1272/2008, Choline hydrogen carbonate 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 hydrogen carbonate has not to be classified and labelled with respect to environmental hazards.