Registration Dossier
Registration Dossier
Diss Factsheets
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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

Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
Teratogenicity in rats and mice: NOAEL developmental toxicity ≥ 2000 mg/kg bw/day actual dose received; no maternal, embryotoxic and / or teratogenic effects (no guideline followed, Teramoto 1981)
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Methylurea was tested for its developmental toxicity at the dose of 2000 mg/kg bw administered orally as a single dose by gavage of an aqueous solution to 15 weeks old Wistar rats (12 animals) on day 12 of pregnancy. On day 20 of pregnancy animals were killed. 1-methylurea had no observable effect on fetal development of rats. Fetal survival and weight of the group treated with this compound were comparable to those of the control group. Therefore, 1-Methylurea was not teratogenic in rats. A NOAEL of about ≥ 2000 mg/kg bw was determined.
In the same study, Methylurea was tested for its developmental toxicity at the dose of 2000 mg/kg bw administered orally as a single dose by gavage of an aqueous solutionto 8 weeks old ICR mice (10 animals) on day 10 of pregnancy. On day 18 of pregnancy animals were killed. 1-methylurea had no observable effect on fetal development in mice. Fetal survival and weight of the group treated with this compound were comparable to those of the control group. A NOAEL of about ≥ 2000 mg/kg bw was determined.
1-Methylurea was not teratogenic in either of the animal species. However, the studies are not reliable due to significant methodological deficiencies (single application, no guideline followed, small number of animals per group).
Justification for classification or non-classification
Based on the insufficient available data, the classification of 1 -methylurea for developmental toxicity according to directive 67/548/EEC and Regulation (EC) No. 1272/2008 is not possible.
Due to missing data, the classification of 1 -methylurea for reproduction toxicity according to directive 67/548/EEC and Regulation (EC) No. 1272/2008 is not possible.
Additional information
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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