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Diss Factsheets
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EC number: 202-498-7 | CAS number: 96-31-1
- 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
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Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- chronic toxicity: other route
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: limited documentation; no control group, only one concentration
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 959
- Report date:
- 1959
- Reference Type:
- publication
- Title:
- 1,3-Dimethylurea (CAS: 96-31-1), SIDS Initial assessment report for SIAM 17
- Author:
- OECD SIDS
- Year:
- 2 009
- Bibliographic source:
- Unep publications
- Report date:
- 2003
Materials and methods
- GLP compliance:
- no
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- - Name of test material (as cited in study report): 1,3-Dimethylurea (CAS: 96-31-1), no further data
Constituent 1
Test animals
- Species:
- dog
- Details on test animals or test system and environmental conditions:
- No data provided.
Administration / exposure
- Route of administration:
- other: oral, by gavage or via feed
- Vehicle:
- water
- Duration of treatment / exposure:
- 50-984 days
- Frequency of treatment:
- 20-323 administrations
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw/day
- No. of animals per sex per dose:
- 11 (10 male, 1 female)
- Control animals:
- no
- Details on study design:
- Post-exposure period: no
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 2 dogs died after the 3rd or 9th administration from intercurrent diseases that were not considered related to the test substance (hepatitis, intestinal invagination)
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 2 dogs died after the 3rd or 9th administration from intercurrent diseases that were not considered related to the test substance (hepatitis, intestinal invagination)
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- 6 animals lost weigt (about 30 %).
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- All animals showed loss of appetite.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Some animals showed leucocytosis.
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Haematuria was the most prominent clinical symptom, and was present in all animals. Haematuria was first noted after 3-4 administrations of the test substance. From the 6th study week onwards, bladder epithelia were found in urinary sediments.
- Behaviour (functional findings):
- effects observed, treatment-related
- Description (incidence and severity):
- All animals showed weakness of hind legs, and 4 animals stiffness of hind legs, wich turned into complete paralysis in one animal after 8 months. 8 of 9 animals had pathological changes in the urinary bladder.
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 3 animals had intestinal inflammation, 3 interstitial nephritis, and 3 pneumonia.
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Thickening of urinary bladder wall, hemorrhages, hypertrophic mucosa, partial loss of epithelia and signs of secondary bacterial infection was observerd. No changes were found in urethrae, ureters, brain, spinal cord or peripheral nerves.
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- OTHER FINDINGS
- 7 animals vomited after application of the test substance
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Basis for effect level:
- other: stiffness and paralysis of the legs
Target system / organ toxicity
- Critical 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.
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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