Registration Dossier
Registration Dossier
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: 247-201-1 | CAS number: 25711-72-2
- 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

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- Final report of the safety assessment of Urea.
- Author:
- Cosmetic Ingredient Review Expert Panel
- Year:
- 2 005
- Bibliographic source:
- International Journal of Toxicology;24 Suppl 3:1-56;2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To assess the dermal irritation potential of urea in mice
- GLP compliance:
- not specified
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
- Test material form:
- solid
- Details on test material:
- Name of the test chemical: Urea
Molecular Weight: 60.0556 g/mol
Molecular Formula:CH4N2O
InChI: 1S/CH4N2O/c2-1(3)4/h(H4,2,3,4)
Substance Type: Organic
Physical State: Solid
Constituent 1
- Specific details on test material used for the study:
- Name of the test chemical: Urea
Molecular Weight: 60.0556 g/mol
Molecular Formula:CH4N2O
InChI: 1S/CH4N2O/c2-1(3)4/h(H4,2,3,4)
Substance Type: Organic
Physical State: Solid
Test animals
- Species:
- mouse
- Strain:
- Nude
- Details on test animals or test system and environmental conditions:
- sex: male
housing: 3/cage
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 1, 10, 25, 50, 75 or 100% urea
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 hours
- Number of animals:
- 3 mice/ formulation
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area, surface area 0.8 sq.cm
- Type of wrap if used: secured with surgical tape and fastened with super glue
Results and discussion
In vitro
- Other effects / acceptance of results:
- no data available
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Urea did not cause any microscopic changes over the 24 hour period at the concentrations tested
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- Urea did not cause any microscopic changes over the 24 hour period at the concentrations tested.
Hence, urea can be considered to be not irritating to the skin of male nude mice. - Executive summary:
A dermal irritation study was performed to assess the irritation potential of urea in mice.
1, 10, 25, 50, 75 or 100% urea was exposed to the skin of 3 male nude mice for 24 hours.3 animals were exposed to each formulation and maintained 3/cage. Urea was placed in a PVC (Polyvinyl chloride) cup with a surface area of 0.8 sq cm and surface volume of 0.3 cubic cm. The cup was fastened to the dorsal side of the animal using surgical tape and secured with Superglue. The mice were killed immediately after the 24 hours exposure period. Specimens of the exposed areas and of the adjacent untreated skin were taken for histological evaluation. Histological assessment included examination for epidermal changes, hyperkeratosis, spongiosis, destruction of the epidermis hyperemia, and increase in the cell layer of the stratum granulosum, increase in the density and thickness of the collagen bundles, fractured collagen, infiltration of the dermis and intracellular edema.
Urea did not cause any microscopic changes over the 24 hour period at the concentrations tested.
Hence, urea can be considered to be not irritating to the skin of male nude mice.
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.
