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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 247-728-7 | CAS number: 26479-35-6
- 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:
- 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: No guideline followed. The study performed with relatively small numbers of animals and a single dose
Data source
Reference
- 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, and Shirasu Y
- Year:
- 1 981
- Bibliographic source:
- Teratology 23(3): 335–42
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Deviations:
- not specified
- Principles of method if other than guideline:
- Dams were dosed via oral gavage to pregnant rats on day 12 of pregnancy and sacrificed on day 20 of pregnancy.
- GLP compliance:
- not specified
- Limit test:
- no
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:
- not specified
- Details on test material:
- Urea from Wako Pure Chemical Industries, Ltd
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: purchased from CLEA, Japan
- Age at study initiation: (P) 15 wks
- Diet: laboratory chow (Oriental Yeast MF), ad libitum
- Water: tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ±1
- Humidity (%): 55 ± 5
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- Aqueous solutions of the compounds (10 mL/kg) were prepared and orally administered to dams.
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Females were paired overnight with a male. The following morning they were examined for the presence of vaginal plug and were designated as being in day 0 of pregnancy when the plug was observed.
- Duration of treatment / exposure:
- Dams were dosed at day 12 of pregnancy
- Frequency of treatment:
- Single dosing
- Duration of test:
- Dosed on day 12 of pregnancy, and sacrificed at day 20 of pregnancy
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Basis:
nominal conc.
2000 mg/kg
- No. of animals per sex per dose:
- 4
- Control animals:
- yes, concurrent vehicle
Examinations
- Fetal examinations:
- - External examinations: Yes: [all per litter]
- Soft tissue examinations: Yes: [ half per litter]
- Skeletal examinations: Yes: [ half per litter]
- Head examinations: No data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
Mortality was not observed.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 2 000 mg/kg bw (total dose)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No significant changes were observed in number of implants, number of live fetuses, % of fetal resorptions, fetal weight or % fetal malformation.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
|
No. Dams |
Mean No of implants |
Mean No. of live fetuses |
% Fetal resorptions |
Mean fetal weight (mg) |
& Fetuses malformed |
Urea (2000mg/kg) |
4 |
13.8±2.2 |
13.8±2.2 |
0 |
3626±104 |
1.8 |
control |
6 |
13.7±1.0 |
13.3±0.8 |
2.4 |
3671±197 |
0 |
Applicant's summary and conclusion
- Conclusions:
- Based on the study, no adverse developmental/teratogenicity effects were observed due to a single, high-dose urea treatment.
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.