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EC number: 204-701-4 | CAS number: 124-43-6
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
- Reference Type:
- publication
- Title:
- Correlation between the molecular structure of N-alkylureas and N-alkylthioureas and their teratogenic properties
- Author:
- Teramoto S, Kaneda M, Aoyama H et al.
- Year:
- 1 981
- Bibliographic source:
- Teratology 23(3):335–342
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Urea (and 10 other urea compounds) were screened for developmental toxicity in pregnant Wistar rats and ICR mice. The animals received a single oral dose of urea at GD 12 (rats) or at GD 10 (mice). The progeny was examined at GD 20 rats or GD 18 (mice) respectively.
- 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
Constituent 1
- Specific details on test material used for the study:
- CAS number: 51-13-6
Purity: not stated
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 15 weeks (rats) or 8 weeks (mice)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on mating procedure:
- no details specified in the assessment report
- Duration of treatment / exposure:
- single dose at GD 12 (rats) or GD 10 (mice)
- Frequency of treatment:
- one single treatment
- Duration of test:
- GD0 trough GD 20 (rats or GD 18 (mice)
Doses / concentrationsopen allclose all
- Dose / conc.:
- 2 000 mg/kg bw (total dose)
- Remarks:
- single dose; rats
- Dose / conc.:
- 2 000 mg/kg bw (total dose)
- Remarks:
- single dose, mice
- No. of animals per sex per dose:
- rats: 4 females
mice: 10 females - Control animals:
- yes
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- Mortality
- Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes / No / No data
Examinations included:
- Number of implantations: Yes
- Number of fetal resorptions: Yes
- Number of malformnd fetuses: Yes
Other examinations:
- number of live and dead fetuses
- fetus weight - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: No data
- Skeletal examinations: No data
- Head examinations: No data
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- no statistically significant difference between vehicle control and urea-treated rats regarding percent fetal resorptions (2.4 vs. 0%)
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- not specified
- Dead fetuses:
- no effects observed
- Description (incidence and severity):
- no statistically significant difference between vehicle control and urea-treated rats regarding number of live fetuses (13.3 ± 0.8 vs. 13.8 ± 2.2)
- Changes in pregnancy duration:
- not examined
- Description (incidence and severity):
- dams sacrificed before parturition
Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not examined
Field "Description (incidence and severity)" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.DescriptionIncidenceAndSeverityEffectsOnPregnancyDuration): dams sacrificed before parturition - Changes in number of pregnant:
- not examined
- Description (incidence and severity):
- only pregnant rats (or mice) were used
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 2 000 mg/kg bw (total dose)
- Based on:
- act. ingr.
- Basis for effect level:
- other: no maternal toxicity noted
- Remarks on result:
- other: one single dose was administered
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- no statistically significant difference between fetuses from vehicle control and urea-treated rats: fetal body weight (3,671 ± 197 mg vs. 3,626 ± 104 mg)
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed
Field "Description (incidence and severity)" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.DescriptionIncidenceAndSeverityFetalPupBodyWeightChanges): no statistically significant difference between fetuses from vehicle control and urea-treated rats regarding fetal body weight (3,671 ± 197 mg vs. 3,626 ± 104 mg) - Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- no statistically significant difference between fetuses from vehicle control and urea-treated rats: number of live fetuses (13.3 ± 0.8 vs. 13.8 ± 2.2),
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Description (incidence and severity):
- no statistically significant difference between fetuses from vehicle control and urea-treated rats: percent fetuses malformed (0 vs. 1.8%)
- Skeletal malformations:
- not specified
- Visceral malformations:
- not specified
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 2 000 mg/kg bw (total dose)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects noted
- Remarks on result:
- other: one single dose administered
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- No maternal effects noted in pregnant rats or mice receiving a single oral dose of 2000 mg/kf bw at GD 12 (rats) or GD 10 (mice)
- Executive summary:
Teramoto et al. (1981) examined the developmental toxicity of urea compounds in pregnant Wistar rats (n=4) and pregnant ICR mice (n=10) that received a single oral dose of urea at 2000 mg/kg bw on gestational day 12 (rats) or GD 10 (mice). Rats were sacrificed on GD 20 (mice: GD 18). The number of implants and live and dead foetuses were counted. Living foetuses from each litter were divided into two groups after being weighed individually and examined for gross abnormalities. Foetuses from the right uterine horn were processed for skeletal examination and those from the left horn were processed for visceral examination. For statistical comparisons, the litter was considered the experimental unit.
No maternal toxicity was noted in rats or mice (data not shown). There were no statistical differences between the vehicle control and the urea-treated rats based on the mean ± SD for number of implants (13.7 + 1.0 vs.13.8 ± 2.2), number of live foetuses (13.3 ± 0.8 vs. 13.8 ± 2.2), percent foetal resorptions (2.4 vs. 0%), foetal body weight (3,671 ± 197 mg vs. 3,626 ± 104 mg), or percent foetuses malformed (0 vs. 1.8%). These endpoints also were unaffected in mice treated with urea (data not shown); (EPA, 2011).
Thus, no maternal or developmental toxicity was noted in pregnant rats or mice receiving a single oral dose of 2000 mg/kg bw. The study protocol does, however, not comply with current guidelines.
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