Registration Dossier
Registration Dossier
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EC number: 224-929-8 | CAS number: 4559-86-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- : no histopathologic examination
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 1,1,3,3-tetrabutyl-urea
- IUPAC Name:
- 1,1,3,3-tetrabutyl-urea
- Reference substance name:
- Tetrabutylurea
- EC Number:
- 224-929-8
- EC Name:
- Tetrabutylurea
- Cas Number:
- 4559-86-8
- Molecular formula:
- C17H36N2O
- IUPAC Name:
- 1,1,3,3-tetrabutylurea
- Test material form:
- other: liquid
- Details on test material:
- no further data
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: ChR-CD
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- no further data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Amount applied: 3.1 - 5.66 mL
- Doses:
- 6250, 9000, 14624, 17206 or 19789 mg/kg bw
- No. of animals per sex per dose:
- 10 m
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration: 14 days
Necropsy of survivors performed: no
Other examinations performed: clinical signs and body weight - Statistics:
- Probit
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 16 742 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 14 422 - 20 325
- Mortality:
- 0/10, 0/10, 4/10, 5/10 and 7/10
- Clinical signs:
- other: >= 6250 mg/kg: salivation, wet and stained perianal area, congestion, stained mouth, nose and feet, chromodacryorrhea, alopecia, tremors, fasciculations, piloerection, and weight loss >= 9000 mg/kg: diarrhoea, weakness and ruffled fur >= 14624 mg/kg: eyes
- Gross pathology:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- With an oral LD50 value of 16742 mg/kg bw in rats, 1,1,3,3-tetrabutyl-urea is practically nontoxic.
- Executive summary:
1,1,3,3-tetrabutyl-urea was tested in an acute oral toxicity study with rats. Five groups of 10 male ChR-CD rats were dosed once via gavage with 6250, 9000, 14624, 17206 or 19789 mg/kg bw. With an oral LD50 value of 16742 mg/kg bw, 1,1,3,3 -tetrabutyl-urea was practically nontoxic.
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