Registration Dossier
Registration Dossier
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EC number: 200-315-5 | CAS number: 57-13-6
Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- sub-chronic toxicity: other route
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary source; report cited in WHO JECFA evaluation
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Urea
- Author:
- Olsen, P.
- Bibliographic source:
- WHO / JECFA Monograph 798: urea (WHO Food Additives Series 32)
- Reference Type:
- publication
- Title:
- Chronic urea intoxication in dogs
- Author:
- Balestru, P.L., Rindi, P. & Biagin, M.
- Year:
- 1 971
- Bibliographic source:
- Experimentia 27: 811-812
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Investigation of the subchronic subcutaneous toxicity of urea in the dog
- 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
- Details on test material:
- No information available
Constituent 1
Test animals
- Species:
- dog
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- 12 dogs unilaterally nephrectomised
Administration / exposure
- Route of administration:
- subcutaneous
- Vehicle:
- not specified
- Details on exposure:
- Urea injected subcutaneously every 8 hours for 45 days
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Urea was administered for 45 days
- Frequency of treatment:
- Urea was administered every 8 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
3000 - 4000 mg/kg bw
- No. of animals per sex per dose:
- 12 animals total
- Control animals:
- not specified
- Details on study design:
- 12 dogs unilaterally nephrectomised injected with urea subcutaneously every 8 hours for 45 days
Examinations
- Observations and examinations performed and frequency:
- Plasma urea levels, behaviour, urine output, blood
- Sacrifice and pathology:
- No information available
- Other examinations:
- No information available
- Statistics:
- No information available
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Administration of urea led to increased diuresis, plasma urea levels were 200 - 700 mg/100ml. The dogs displayed mild drowsiness. Hematocrit, platelect counts and EEG were not affected.
Effect levels
- Dose descriptor:
- conc. level: 10% urea solution (3000-4000 mg/kg bw)
- Sex:
- male/female
- Basis for effect level:
- other: Low toxicity: causes increased diuresis and increased drowsiness.
- Remarks on result:
- not measured/tested
- Remarks:
- Effect level not specified (migrated information)
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Administration of urea led to increased diuresis, plasma urea levels were 200 - 700 mg/100ml. The dogs displayed mild drowsiness. Haematocrit, platelet counts and EEG were not affected.
Applicant's summary and conclusion
- Conclusions:
- The study indicates that urea is of very low toxicity in the dog following repeated administration.
- Executive summary:
Twelve unilaterally nephrectomized dogs were injected subcutaneously with 10% urea solution (3000-4000 mg/kg bw) every 8 hours over a period of 45 days. Administration led to increased diuresis, plasma urea levels were 200 - 700 mg/100ml. The dogs displayed mild drowsiness. Haematocrit, platelet counts and EEG were not affected. The study indicates that urea is of very low toxicity in the dog following repeated administration.
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