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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 204-625-1 | CAS number: 123-41-1
- 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
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1969-06-19 to 1969-10-07
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Not all details are given in test report and test was performed on the read-across substance choline chloride; however, the available data indicate that the study was well-performed.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1969-06-19 to 1969-10-07
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Not all details are given in test report and it was performed on the read-across substance Choline chloride; however, the available data indicate that the study was well-performed.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- A relevant guideline was not yet developed at the time the study was conducted.
An aqueous suspension of the test item choline chloride was administered once orally by gavage to rats with a post-observation period of 7 days. - GLP compliance:
- no
- Remarks:
- Conduction of the study prior to GLP
- Test type:
- other: no data
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 %
- Justification for choice of vehicle: insoluble in oil
- with Tragacanth - Doses:
- no data
- No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- ca. 11 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- Choline chloride 50 %
- Remarks on result:
- other: applied as 30 % aqueous suspension in water with tragacanth
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- ca. 5 500 mg/kg bw
- Based on:
- other: pure choline chloride
- Remarks on result:
- other: re-calculated from LD50 of Choline chloride 50 %
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- ca. 4 770 mg/kg bw
- Based on:
- other: choline hydroxide
- Remarks on result:
- other: re-calculated from LD50 of pure Choline chloride
- Mortality:
- Observed but not quantitatively denoted; at least 5 animals in whole trial.
- Clinical signs:
- other: Apathy, Dyspnoe, Calm behavior, accelerated respiration, individually chewing constraint, huddled posture and wet, dirty and shaggy fur
- Gross pathology:
- Dead Animals: 5 x more or less serous smeared snout, particularly ani, diarrhea, elsewise sepsis
Killed animals: 2 x pneumonia in the right upper half of lungs, 1x reduced bodyweight, bronchopneumonia, elsewise organs with negative results - Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The present study was assessed as reliable with restrictions (Klimisch 2), because not all details are given in test report and it was performed on the read-across substance choline chloride. However, the available data indicate that the study was well-performed and consequently the obtained results are sufficiently reliable to assess the acute toxicity of choline chloride, and hence choline base, in rats.
Since the absorption after oral application is very likely to have remained unchanged, information gained from choline chloride for this endpoint can be used as supporting information without modification. This is due to the fact that, if ingested orally, the contact time of the basic solution to the oesophagus is rather short for causing severe chemical burns which will be necessary to enlarge the oral uptake. Once reaching the stomach, the basic pH of the choline base solution will be immediately neutralized by the gastric acid. Only when ingesting large amounts of choline base, the neutralization capacity of the stomach acid will be used up. However, this scenario is unlikely due to expected pain in the oral cavity and pharynx caused by hydroxide.
The LD50 was determined to be ca. 11000 mg/kg of the test item, applied as an 30 % aqueous solution with Tragacanth, which corresponds to ca. 5500 mg/kg of the pure choline chloride or 4770 mg/kg bw choline hydroxide, respectively. Consequently, choline hydroxide does not need to be classified as hazardous according to Regulation 1272/2008/EC. - Executive summary:
In an acute oral toxicity study with a 7 d post-observation period, rats were given 11000 mg/kg bw of the read-across substance Choline chloride 50%, applied as a 30 % aqueous suspension with tragacanth. The oral LD50 was determined to be ca. 11000 mg/kg of the test item, which corresponds to ca. 5500 mg/kg of pure choline chloride or 4770 mg/kg bw choline hydroxide, respectively. Clinical signs were apathy, dyspnoe, calm behavior, accelerated respiration, individually chewing constraint, huddled posture and wet, dirty and shaggy fur, necropsy findings were more or less serous smeared snout (5 x), particularly ani, diarrhoea, elsewise sepsis (dead animals) and pneumonia in the right upper half of lungs (2 x), reduced body weight (1 x), bronchopneumonia, elsewise organs with negative results (killed animals), respectively.
In summary, choline hydroxide is of very low acute oral toxicity based on the LD50 of 4770 mg/kg in rats and does therefore not need to be classified as hazardous according to Regulation 1272/2008/EC.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 969
- Report date:
- 1969
Materials and methods
- Principles of method if other than guideline:
- A solution of the test item (4 % in aqua dest.) was administered to mice via intraperitoneal injection.
- GLP compliance:
- no
- Remarks:
- Conduction of the study prior to GLP
- Limit test:
- no
Test material
- Reference substance name:
- Choline chloride
- EC Number:
- 200-655-4
- EC Name:
- Choline chloride
- Cas Number:
- 67-48-1
- Molecular formula:
- C5H14NO.Cl
- IUPAC Name:
- 2-hydroxy-N,N,N-trimethylethanaminium chloride
- Test material form:
- other: solid, but applied as suspension
- Details on test material:
- - Name of test material (as cited in study report): Cholinchlorid Pulver 50 %
- Structural formula attached as image file (if other than submission substance): see illustration
- Substance type: formulation, solid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- other: Water with tragacanth
- Details on exposure:
- The substance was administered via intraperitoneal (i. p.) injection to mice.
- Doses:
- ca. 550 mg/kg applied as a 4 % (w/v) solution in aqua dest. with water
- No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs
Results and discussion
Effect levelsopen allclose all
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- ca. 550 mg/kg bw
- Based on:
- test mat.
- Remarks:
- Choline chloride 50 %
- Remarks on result:
- other: applied as 4 % (w/v) solution
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- ca. 275 mg/kg bw
- Based on:
- act. ingr.
- Remarks:
- Choline chloride
- Remarks on result:
- other: re-calculated for pure substance
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- ca. 240 mg/kg bw
- Based on:
- other: choline hydroxide
- Remarks on result:
- other: re-calculated from LD50 of pure choline chloride
- Mortality:
- Observed but not quantitatively denoted.
- Clinical signs:
- Ventral position, myoclonus and tremor, exophthalmos, dispnoea or accelerated and precussive respiration, cyanosis, huddled posture, sunken flanks, clotted eyes and fluffed fur
- Gross pathology:
- Dead Animals: sepsis
Killed animals: 4x bracket-formed adhesions on the liver, elsewise organs with negative results
Applicant's summary and conclusion
- Conclusions:
- The present study was assessed as reliable with restriction (Klimisch 2), because not all details are given in test report. However, the available data indicate that the study was well-performed and consequently the obtained results are sufficiently reliable to assess the acute toxicity of Choline chloride after intraperitoneal injection in mice. The LD50 i.p. was determined to be ca. 550 mg/kg of the test item in a 4 % aqueous solution of the test item, which corresponds to ca. 275 mg/kg of the pure Choline chloride and recalculated for choline hydroxide to 240 mg/kg bw, assuming, that choline base would have been applied as pH-neutralized solution.
- Executive summary:
In an acute toxicity study with i.p. injection and a 7 d post-observation period, mice were given a 4 % aqueous solution of the read-across substance choline chloride (50 %) with tragacanth. The i.p. LD50 was determined to be ca. 550 mg/kg of the test item applied in a 4 % solution, which corresponds to ca. 275 mg/kg of the pure Choline chloride and hence 240 mg/kg bw of choline hydroxide. Clinical signs were ventral position, myoclonus and tremor, exophthalmos, dispnoea or accelerated and precussive respiration, cyanosis, huddled posture, sunken flanks, clotted eyes and fluffed fur, necropsy findings were sepsis (dead animals) and bracket-formed adhesions on the liver (4x), elsewise organs with negative results (killed animals), respectively.
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.