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EC number: 209-935-0 | CAS number: 598-50-5
- 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:
- other information
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: non-guideline study with significant methodological deficiencies (single application, small number or animals per dose group, only one dose tested (= MTD))
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Correlation Between the Molecular Structure of N-Alkylureas and N-Alkylthioureas and Their Teratogenic Properties
- Author:
- Teramoto, S
- Year:
- 1 981
- Bibliographic source:
- Teratology 23 :335-342
- Reference Type:
- publication
- Title:
- Teratogenicity of ureas in rats and mice.
- Author:
- Kaneda M
- Year:
- 1 980
- Bibliographic source:
- Teratology 22 (1): 18A; abstract
Materials and methods
- Principles of method if other than guideline:
- Eleven urea compounds were administered individually as a single maximum tolerated oral dose to pregnant rats either on day 12 or 14 of gestation and to pregnant mice on day 10 of gestation. Teratogenicity in rats and mice was investigated.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Methylurea
- EC Number:
- 209-935-0
- EC Name:
- Methylurea
- Cas Number:
- 598-50-5
- Molecular formula:
- C2H6N2O
- IUPAC Name:
- methylurea
- Details on test material:
- - Name of test material (as cited in study report): methylurea
- no further data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CLEA, Japan
- Age at study initiation: 15 weeks
- Weight at study initiation: No data
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): aboratory chow (Oriental Yeast MF), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 1 °C
- Humidity (%): 55 ± 5 %
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Aqueous solutions were prepared and given orally to female rats by intubation.
VEHICLE
- Amount of vehicle (if gavage): 10 ml/kg - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: No data
- Length of cohabitation: overnight
- Proof of pregnancy: vaginal plug referred to as day 0 of pregnancy - Duration of treatment / exposure:
- day 12 of gestation
- Frequency of treatment:
- single application
- Duration of test:
- cesarean section at day 20 of pregnancy
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2000 mg/kg bw
Basis:
- No. of animals per sex per dose:
- 6 females
- Control animals:
- yes, concurrent vehicle
- other: urea as negative control... (see attached file)
- Details on study design:
- - Dose selection rationale:
A maximum-tolerated dose was first determined by treating nonpregnant female rats with a single oral dose of the compound in dosages of 1000 and 2000 mg/kg. The animals were examined for deaths or toxic signs such as depression, diarrhea, etc ., for one week. When neither death nor any sign of toxicity was observed for a dose, that dose was selected as the maximum-tolerated dose that could be used.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 20
- Organs examined: No data - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: No data
- Number of implantations: Yes
- Number of resorptions: Yes
Other examinations:
- live and dead fetuses - Fetal examinations:
- • Living fetuses from each litter were divided into two groups after they were weighed individually and examined for gross abnormalities.
• One group which was derived from the right uterine horn was processed for skeletal examinations according to the differential staining method of Inouye
• The other group of fetuses was fixed in Bouin's fluid and examined for visceral anomalies by the razor-blade sectioning method (Barrow and Taylor, 1969).
- External examinations: Yes, all per litter
- Soft tissue examinations: Yes, half per litter
- Skeletal examinations: Yes, half per litter
- Head examinations: No data - Statistics:
- Student's t test was used for analysing differences in numbers of implants and live fetuses and fetal body weights between treated and control groups.
Differences in resorption and malformation incidences, assessed on the basis of number of affected fetuses, were analyzed by the Chisquare test . - Indices:
- No indices were calculated.
- Historical control data:
- No data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no data
Details on maternal toxic effects:
No obvious signs of toxicity and no mortality in rats at dosages up to 2000 mg/kg body weight were observed.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 2 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
1-methylurea had no observable effect on fetal development in rats. Fetal survival and weight of the group treated with this compound were comparable to those of the control group.
- Mean No. of implants (± SD): 1-Methylurea: 13.8 ± 1.0; Control: 13.7 ± 1.0; Urea: 13.8 ± 2.2
- Mean No. of live fetuses (± SD): 1-Methylurea: 13.2 ± 0.8; Control: 13.3 ± 0.8; Urea: 13.8 ± 2.2
- % Fetal resorptions: 1-Methylurea: 4.8; Control: 2.4; Urea: 0.0
- Mean fetal weight (mg ± SD): 1-Methylurea: 3697 ± 253; Control: 3671 ± 197; Urea: 3626 ± 104
- % Fetuses malformed: 1-Methylurea: 0.0; Control: 0.0; Urea: 1.8
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
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.
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