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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 200-315-5 | CAS number: 57-13-6
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Published study, non-standard method
Data source
Reference
- Reference Type:
- publication
- Title:
- Absence of urea toxicity in young pigs
- Author:
- Button, C. Joubert, J.P. Maartens, B.P.
- Year:
- 1 982
- Bibliographic source:
- Journal of the South African Veterinary Association 53(1): 67-68
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Acute oral dose, presented in feed
- GLP compliance:
- no
- Remarks:
- : older, published study
- Test type:
- other: investigative study: non-standard method
- Limit test:
- yes
Test material
- Reference substance name:
- Urea
- EC Number:
- 200-315-5
- EC Name:
- Urea
- Cas Number:
- 57-13-6
- Molecular formula:
- CH4N2O
- IUPAC Name:
- urea
- Details on test material:
- Laboratory grade urea.
Constituent 1
Test animals
- Species:
- pig
- Strain:
- other: cross-Landrace
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Young male cross-Landrace piglets; 10 weeks old (litter mates). The piglets weighed 14, 16 and 13 kg. The piglets were housed in individual stalls, bedded with straw and had water freely available.
Administration / exposure
- Route of administration:
- other: oral dosing gun, and oral in feed
- Vehicle:
- other: water or feed
- Details on oral exposure:
- Testing commenced with acute oral doses of urea dissolved in water and administered by dosing gun. Following this piglets were fed a dry pig meal containing urea for 10 days. One piglet was given two further oral doses in water, and two piglets were fed the urea diet for a further 5 days (Table 1).
Each pig was offered 1 kg food per day. - Doses:
- Various - see Table 1
- No. of animals per sex per dose:
- 3 male piglets
- Control animals:
- no
- Details on study design:
- Three litter mates were exposed to urea via acute oral doses and in the feed.
- Statistics:
- No information available
Results and discussion
- Preliminary study:
- No information available
Effect levels
- Sex:
- male
- Dose descriptor:
- LDLo
- Effect level:
- > 16 000 mg/kg bw
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No symptoms suggestive of urea toxicity were seen.
- Gross pathology:
- Pathology was not performed.
- Other findings:
- No other findings reported.
Any other information on results incl. tables
Urea was non-toxic to a 10 week old pig in an acute dose as high as 16 g/kg bw. 10% mass/mass urea in pig food over a period of 5 days did not result in any signs of toxicity.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information : non-standard species Criteria used for interpretation of results: EU
- Conclusions:
- Urea was non-toxic to a 10 week old pig in an acute dose as high as 16 g/kg bw. 10% mass/mass urea in pig food over a period of 5 days did not result in any signs of toxicity.
- Executive summary:
Urea was non-toxic to a 10 week old pig in an acute dose as high as 16 g/kg bw. 10% mass/mass urea in pig food over a period of 5 days did not result in any signs of toxicity.
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.