Registration Dossier
Registration Dossier
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EC number: 203-845-5 | CAS number: 111-20-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Disodium sebacate
- EC Number:
- 241-300-3
- EC Name:
- Disodium sebacate
- Cas Number:
- 17265-14-4
- Molecular formula:
- C10H18O4.2Na
- IUPAC Name:
- disodium sebacate
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6-7 weeks.
- Weight at study initiation: ♂ 168 g, ♀ 146 g
- Housing: Animals were caged separated
- Fasting period before study: 18 h
- Diet: ad libitum, commercial pelleted diet (Oakes Special Diet with added Vit. E)
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ±2
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 5000 mg/kg
- Amount of vehicle: 25% (w/v) solution, 20 mL/kg - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical symptoms, gross pathology
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No substance related mortality was seen.
- Clinical signs:
- other: No substance related clinical effects were seen.
- Gross pathology:
- No pathological substance related changes were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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