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Diss Factsheets
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EC number: 244-343-6 | CAS number: 21351-39-3
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Published study; non-standard method. The study is poorly reported and its value/relevance limited by the extreme dose level used, which is well in excess of the currently accepted limit dose.
Data source
Reference
- Reference Type:
- publication
- Title:
- EFFECTS OF UREA ON MITOTIC CHROMOSOMES OF MICE AND ONION
- Author:
- Chaurasia, O.P. & Sinha, S.P.
- Year:
- 1 987
- Bibliographic source:
- Cytologia 52(4): 877-882
Materials and methods
- Principles of method if other than guideline:
- Bone marrow cytogenetic assay in mice
- GLP compliance:
- not specified
- Remarks:
- : published study
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- Urea
- EC Number:
- 200-315-5
- EC Name:
- Urea
- Cas Number:
- 57-13-6
- IUPAC Name:
- urea
- Details on test material:
- No information available; purity unknown
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Swiss albino mice
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- Diet
- Details on exposure:
- Mice were fed 500 mg/animal per day in food for 5 days
- Duration of treatment / exposure:
- 5 days
- Frequency of treatment:
- Daily
- Post exposure period:
- Seven days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500 mg/animal
Basis:
nominal in diet
- No. of animals per sex per dose:
- No information available:
- Control animals:
- yes, plain diet
- Positive control(s):
- None
Examinations
- Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- Bone marrow cells were separated, concentrated and stained with Giemsa
- Evaluation criteria:
- No information available
- Statistics:
- No information available
Results and discussion
Test results
- Sex:
- not specified
- Genotoxicity:
- positive
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- Bone marrow cell metaphases exhibited chromosome breaks, acentric fragments, translocations, gaps and constrictions at a 7-fold rate compared to controls.
Any other information on results incl. tables
Bone marrow cell metaphases exhibited chromosome breaks, acentric fragments, translocations, gaps and constrictions at a 7-fold rate compared to controls.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): ambiguous
Bone marrow cell metaphases exhibited chromosome breaks, acentric fragments, translocations, gaps and constrictions at a 7-fold rate compared to controls. However the interpretation of the clastogenic effect is limited by the usage of a single extremely high dose level. - Executive summary:
The potential of urea to cause chromosomal aberrations was investigated in the bone marrow of Swiss mice. Mice (number unspecified) were administered urea in the diet at a dose level of 500 mg/day for 5 days. Animals were sacrificed after a receivery period of 7 days and the bone marrow harvested. A total 300 metaphases from treated animals and untreated controls were assessed for chromosomal aberration.
A marked increase in the incidence of chromosomal aberrations was seen in the treated group (7x controls). However the dose level administered in this study is equivalent to 16 -17 g/kg bw/day and is thus far in excess of the limit dose of 1000 mg/kg bw. Signs of toxicity are not reported, but marked toxicity can be predicted at this dose level.
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