Choline chloride

PBT assessment

PBT assessment: overall result

Reference

Reference 1

Name:

2-Hydroxyethyl trimethylammonium chloride

Type of composition:

boundary composition of the substance

State / form:

other: aqueous solution

Reference substance:

2-Hydroxyethyl trimethylammonium chloride

Reference 2

Name:

2-Hydroxyethyl trimethylammonium chloride

Type of composition:

legal entity composition of the substance

State / form:

other: aqueous solution

Reference substance:

2-Hydroxyethyl trimethylammonium chloride

PBT status:

the substance is not PBT / vPvB

Justification:

Criteria for assessing PBT properties are defined in Annex XIII, REACH Regulation (EC) No 1907/2006. Further details are laid down in ECHA Guidance on Information Requirements and Chemical Safety Assessment; Chapter R.11: PBT Assessment (June 2017). The assessment of PBT / vPvB properties is based upon a separate assessment for each parameter (i.e. P or vP, B or vB and T). Substances are only assigned as PBT or vPvB when they fulfill the criteria for all three properties (persistency, bioaccumulation and toxicity in case of PBT substance) or both criteria (i.e. very persistent and very bioaccumulative) in case of vPvB, respectively.

Based on a valid experimental result, Choline chloride is considered as "readily biodegradable" (BASF AG, 1988) and therefore not persistent in the environment. Also the B criterion (Bioaccumulative substance) is not fulfilled based on the experimentally determined logPow of -3.77 (BASF AG, 1988) and the QSAR predicted Bioconcentration Factor (BCF) of 3.16 L/kg (Chemservice S.A., 2018b, apdated 2022), which is far below the trigger value of 100 L/kg. Due to the lack of toxicity observed in ecotoxicity studies, also the first T screening criterion is not fulfilled. Furthermore, no classification exists as carcinogenic, mutagenic or toxic for reproduction according to Regulation (EC) No 1272/2008. The test substance is neither classified as "T, R48" or as "Xn, R48" based on the criteria laid down in Directive 67/548/EEC nor as STOT RE category 1 or 2 so far.

As conclusion, Choline chloride fulfills none of the required parameters and is neither a PBT nor a vPvB substance.

Likely routes of exposure:

Choline chloride is marketed as a aqueous, colorless and nearly odourless liquid. Workers may be exposed via the dermal route due to substance handling during manufacture. Based on the substance specific properties (i.e. logPow -3.77; BASF AG, 1988) the substance will be able to diffuse into the dermis but no deeper layers of the skin, i.e. neither the epidermis nor any bloodstream layers will be crossed. Based on the low vapour pressure of the substance, an uptake via the inhalative route is not relevant. Oral exposure is not relevant based on the handling, education and safety precautions in the factory. As conclusion, only the dermal exposure route may be relevant for humans.