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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 200-680-0 | CAS number: 68-19-9
- 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)
Endpoint summary
Administrative data
Description of key information
Acute toxicity (oral):
Supporting study: Only few data on test method reported. No toxic effects were observed for the test substance up to a dose level of 5000 mg/kg bw/day.
Acute toxicity (other routes):
Supporting study: No guideline was followed. Only few data on test method reported. The intraperitoneal and subcutaneous LD100 of Vitamin B12 is determined to be 3 mg/kg.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Only few data on test method reported.
- GLP compliance:
- not specified
- Test type:
- other: Writhing test
- Limit test:
- no
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Lippische Vesuchstierzucht, Hagemann GmbH & Co, Extertal, FRG.
- Weight at study initiation: 21-28g.
- Diet (e.g. ad libitum): standard mouse diet, ad libitum.
- Water (e.g. ad libitum): ad libitum. - Route of administration:
- oral: gavage
- Vehicle:
- other: hydroxypropyl methylcellulose gel.
- Details on oral exposure:
- DOSAGE PREPARATION
The test compound was suspended in 0.8% aqueous hydroxypropyl methylcellulose gel.
The test substance was given alone or in combination at a ratio of 1:1:0.0025 for thiamine, pyridoxine, and cyanocobalamin. - Doses:
- Not determined
- No. of animals per sex per dose:
- Groups of 5 animals
- Control animals:
- yes
- Statistics:
- A Kruskal-Wallis one-way analysis of variance in conjunction with a Wilcoxon two-sample test was used for the statistical analysis.
- Sex:
- female
- Dose descriptor:
- discriminating dose
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: (maximum tolerated dose)
- Mortality:
- No mortality was observed for cyanocobalamine given alone or in combination up to a dose level of 5000 mg/kg bw.
- Clinical signs:
- other: No toxic effects were observed for cyanocobalamine given alone or in combination up to a dose level of 5000 mg/kg bw.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No toxic effects were observed for the test substance up to a dose level of 5000 mg/kg bw/day.
- Executive summary:
In the present acute oral toxicity study, the maximum tolerated dose was determined for cyanocobalamin. The test substance was given alone or in combination at a ratio of 1:1:0.0025 for thiamine, pyridoxine, and cyanocobalamin, to female mice. No toxic effects were observed for the test substance given alone or in combination up to a dose level of 5000 mg/kg bw/day.
Reference
Following repeated oral administration for 7 days cyanocobalamin alone exerted a slight antinociceptive effect at 5620 mg/kg bw p.o.
The number of writhing reactions was reduced by 18% compared to the control.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Only few data on test method reported.
Additional information
Acute toxicity (oral):
Supporting study: In the present acute oral toxicity study, the maximum tolerated dose was determined for cyanocobalamin. The test substance was given alone or in combination at a ratio of 1:1:0.0025 for thiamine, pyridoxine, and cyanocobalamin, to female mice. No toxic effects were observed for the test substance given alone or in combination up to a dose level of 5000 mg/kg bw/day.
Acute toxicity (other routes):
Supporting study: Forty albino mice were given intraperitoneal injections of Cyanocobalamin in doses of 0.75, 1.5 and 3 mg/kg and 3 mg/kg of the test substance subcutaneously. On the basis of the study findings, it can be stated that an intraperitoneal dose of 0.75 mg/kg is devoid of toxicity, while an intraperitoneal dose of 1.5 mg/kg is toxic, causing excitation and convulsions to the exposed animals. The highest dose tested (3 mg/kg) is lethal for 100 per cent of the animals treated, administered either intraperitoneally or subcutaneously. Mice that died after injection of the test substance showed no pathologic changes other than congestion of the lung. From these findings, the intraperitoneal and subcutaneous LD100 of the test item is determined to be 3 mg/kg.
Justification for selection of acute toxicity – oral endpoint
Only one study available.
Justification for classification or non-classification
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)