Registration Dossier
Registration Dossier
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EC number: 305-673-7 | CAS number: 94944-95-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August-September 1977
- 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:
- 1 977
- Report date:
- 1977
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:
- Fatty acids, C18-36, esters with ethylene glycol
- EC Number:
- 305-673-7
- EC Name:
- Fatty acids, C18-36, esters with ethylene glycol
- Cas Number:
- 94944-95-3
- Molecular formula:
- C40H78O4/C70H138O4
- IUPAC Name:
- Fatty acids, C18-36, esters with ethylene glycol
- Test material form:
- liquid - liquid: emulsion
- Details on test material:
- 40% solution in sesame oil
Lot 132-3206-2
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CFY
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data
initial average body weights between males 102-105 g, females 96-101 g
Animals were fasted overnight prior to dosing
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 40% in corn oil
MAXIMUM DOSE VOLUME APPLIED: 40 mL/kg bw - Doses:
- 16 g/kg bw
- No. of animals per sex per dose:
- 5 males + 5 females
- Control animals:
- yes
- Remarks:
- treated with 40 ml/kg bw corn oil
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: on day 0 , 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs frequency not indicated - Statistics:
- NA
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 16 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 6 400 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- none
- Clinical signs:
- other: piloerection, hunched posture and diarrhea (in one female) shortly after dosing (until day 6)
- Gross pathology:
- no abnormalities (similar to controls)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the substance is > 6400 mg/kg bw
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