Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-137-0 | CAS number: 78-73-9
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only abstract available
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Abstracts Thirty-Third Annual Meeting American College of Clinical Pharmacology October 3-5, 2004, Litchfield Park (Phoenix), Arizona - Prolonged sympathic stimulation with oral choline and urinar yexcretion of histamine and catecholamines in the rat
- Author:
- Salazar-Rodriguez M, Sosa A, Campos HA
- Year:
- 2 004
- Bibliographic source:
- J Clin Pharmacol 2004 44: 1185/1203
- Reference Type:
- publication
- Title:
- Abstracts Thirty-Third Annual Meeting American College of Clinical Pharmacology October 3-5, 2004, Litchfield Park (Phoenix), Arizona -Sympathic stimulation with oral choline fails to increase urinary histamine excretion in spontaneously hypertensive rats
- Author:
- Sosa A, Salazar-Rodriguez M, Losada M, Campos HA
- Year:
- 2 004
- Bibliographic source:
- J Clin Pharmacol 2004 44: 1185/1203
Materials and methods
- Principles of method if other than guideline:
- The study originally aimes to examine urinary excretion, determination of toxic effects of the compounds were side-observations. Rats were administered orally by gavage the test compound on three consecutive days.
- GLP compliance:
- not specified
- Test type:
- other: 3 d intermittend gavage
- Limit test:
- no
Test material
- Reference substance name:
- Choline
- EC Number:
- 200-535-1
- EC Name:
- Choline
- Cas Number:
- 62-49-7
- IUPAC Name:
- 2-hydroxy-N,N,N-trimethylethanaminium
- Reference substance name:
- choline chloryde
- IUPAC Name:
- choline chloryde
- Reference substance name:
- Choline chloride
- EC Number:
- 200-655-4
- EC Name:
- Choline chloride
- Cas Number:
- 67-48-1
- IUPAC Name:
- 2-hydroxy-N,N,N-trimethylethanaminium chloride
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): choline / choline chloryde
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley / spontaneously hypertensive rats (SHR), Sprague-Dawley and Wistar
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Sprague-Dawley rats
- Sex: male
- Weight at study initiation: 300-400 g
- Housing: individually in metabolic cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Sprague-Dawley / spontaneously hypertensive rats (SHR), Sprague-Dawley and Wistar
- Sex: unknown
- Weight at study initiation: 250-300 g
- Housing: individually in metabolic cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- Rats were administered orally with destilled water, 4 mL/kg, for 3 days. Days 4, 5 and 6 choline (20 mmole each) in the same volume was administered daily by the same route. Days 7, 8 and 9, water was again administered orally.
- Doses:
- 20 mmole/kg (i.e. 2.79 g/kg bw) each on three consecutive days, resulting in an total amount of 8.37 g/kg bw.
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: at least 3 days
- Other examinations performed: urinary analysis
Results and discussion
Effect levelsopen allclose all
- Sex:
- not specified
- Dose descriptor:
- LD0
- Effect level:
- >= 2 790 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: given on three consecutive days, hence LD0 can be calculated as intermittent total dose to 8.37 g/kg bw
- Sex:
- not specified
- Dose descriptor:
- LD0
- Effect level:
- >= 3 300 mg/kg bw
- Based on:
- other: Choline bicarbonate
- Remarks on result:
- other: re-calculated from LD0 of pure Choline chloride; given on three consecutive days, hence LD0 can be calculated as intermittent total dose to 9.90 g/kg bw
- Mortality:
- none
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Although only abstracts are available and hence the reliability is not assessable, the results are consistent with the data provided in the key study, so the LD0 ≥ 3.30 g/kg bw resp. LD0 ≥ 9.90 g/kg (three consecutive days, intermittent gavage) obtained in this study can be used to support the classification of being practically nontoxic as stated in the key study.
- Executive summary:
Male Sprague-Dawley rats resp. spontaneously hypertensive rats (SHR), Sprague-Dawley and Wistar rats were administered orally on each three consecutive days 20 mmole (i.e. 2.79 g/kg bw) of of the read-across substance choline chloride, which results in a total, intermittent dose of 8.37 g/kg bw. This dosage corresponds to 3.30 g/kg bw/d and 9.90 g/kg bw choline bicarboante, respectively. No mortalities were observed, so the LD0 was found to be LD0 ≥ 3.30 g/kg bw resp. LD0 ≥ 9.90 g/kg (three consecutive days, intermittent gavage), and hence Choline hydrogen carbonate can be considered to be practically nontoxic.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)