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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Published public domain study, non-standard method
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicological model investigation of chicken embryo
- Author:
- Mora, S., Simon, F. & Kapp, P.
- Year:
- 1 991
- Bibliographic source:
- Acta Veterinaria Scandinavica, Suppl. 87: 197-198
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Screening assay: test substance injected into the air sac of chicken eggs during incubation
- GLP compliance:
- not specified
- Remarks:
- : published study
- Limit test:
- no
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:
- Purity grade: analytical
Constituent 1
Test animals
- Species:
- other: chick embryo
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- Chick embryo, at days 16, 17 and 18 of incubation
Administration / exposure
- Route of administration:
- other: injection into egg air sac
- Vehicle:
- water
- Details on exposure:
- Urea dissolved in distilled water was injected into the air sac of the chick eggs on day 16, 17, and 18 of incubation.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No information available
- Details on mating procedure:
- Not relevant
- Duration of treatment / exposure:
- Exposure to substance occurred at day 16, 17, and 18 of incubation
- Frequency of treatment:
- Exposure to substance occurred at day 16, 17, and 18 of incubation
Doses / concentrations
- Remarks:
- Doses / Concentrations:
200, 400, 800, and 1200 mg/kg egg
Basis:
nominal in water
- No. of animals per sex per dose:
- No information available
- Control animals:
- yes
- Details on study design:
- Blood samples were taken on Day 19; AST and LDH activities were assessed. T3 and T4 were measured by RIA
Examinations
- Maternal examinations:
- Not relevant
- Ovaries and uterine content:
- Not relevant
- Fetal examinations:
- Electron microscopy and plasma biochemistry
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:not examined
Details on maternal toxic effects:
Not relevant
Effect levels (maternal animals)
- Dose descriptor:
- other: mortality varied between 8.8 and 38.9%, dose dependently
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
Mortality of the embryos varied between 8.8 and 38.9%, dose-dependently. Plasma T3 level increased and plasma T4 level decreased. Electron microscopy revealed cytoplasmic oedema, mitochondrial swelling and membrane damage in thyroid cells.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
The mortality in the control group was 6.1%.
Applicant's summary and conclusion
- Conclusions:
- Mortality of the embryos varied between 8.8 and 38.9%, dose-dependently. The mortality in the control group was 6.1%. Plasma T3 level increased and plasma T4 level decreased. Electron microscopy revealed cytoplasmic oedema, mitochondrial swelling and membrane damage in thyroid cells.
- Executive summary:
Urea in 0.05 ml water was injected into incubated fertilised chick eggs on Days 16, 17 and 18 at dose levels of 200, 400, 800 or 1200 mg/kg egg weight. AST and LDH activities were assessed in Day 19 blood samples. T3 and T4 levels were measured by RIA. The thyroid was investigated by electron microscopy. Mortality of the embryos varied between 8.8 and 38.9%, dose-dependently. The mortality in the control group was 6.1%.
Plasma T3 level increased and plasma T4 level decreased. Electron microscopy revealed cytoplasmic oedema, mitochondrial swelling and membrane damage in thyroid cells. The authors indicate that urea causes thyroid damage, however this conclusion is not considered to be reliable given the absence of other investigations and the level of general toxicity seen in this study.
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.
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