Registration Dossier
Registration Dossier
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EC number: 202-498-7 | CAS number: 96-31-1
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
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