Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 200-655-4 | CAS number: 67-48-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Choline chloride was neither classified as mutagenic nor revealed any evidence in the available subacute, subchronic or chronic study, i.e. hyperplasia and/or pre-neoplastic lesions, for the classification as carcinogen. Hence, it does not need to be classified according to Regulation 1272/2008/EC.
Additional information
According to REACH Annex X column 2, a carcinogenicity study may be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if:
– the substance has a widespread dispersive use or there is evidence of frequent or long-term human exposure; and
– the substance is classified as mutagen category 3 or there is evidence from the repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.
In the 2-year repeated dose toxicity study in rats (Shivapurkar N, 1986), no adverse effects were detected compared to control. In fact, although not statistically significant, Choline chloride treated animals developed less tumors than control animals. Also, no effects were seen regarding body weight gain, and the relative liver weight was also slightly, but not significantly decreased compared to control. This could be due to the fact that Choline chloride, which is also used as a feed additive, is an effective methyl donor, which does not require extensive metabolic pathways, which could possibly lead to additional liver damage due to hazardous degradation products. Hence, it is likely that CC does not only exhibit no adverse effects but also liver-protecting effects. Most likely effects for an increased liver weight can be (non)-neoplastic lesions, fatty liver or scar formation / cirrhosis due to necrosis already on only single cellular level, and also an increased requirement of metabolic enzymes. These effects are diminished by an additional gavage of Choline chloride.
Hence, there is no evidence from the 2-year repeated dose study, as well as in the available subacute and subchronic studies, that the substance is able to induce hyperplasia and/or pre-neoplastic lesions. Consequently, testing for carcinogenicity is not necessary and no additional testing needs to be proposed by the applicant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

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