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Registration Dossier
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EC number: 943-428-1 | CAS number: -
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:
- other: Basic data given (analytical purity of test substance not specified).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 966
- Report date:
- 1966
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- (analytical purity of test substance not specified)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Tween 61
- IUPAC Name:
- Tween 61
- Details on test material:
- - Name of test material (as cited in study report): Tween 61
- Physical state: tan solid
- Lot/batch No.: 211
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Manor Farms Research, Inc.
- Weight at study initiation: 150 g (141-157 g)
- Fasting period before study: 16 h
- Diet: ad libitum after dosing
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- , but melted to approximately 40°C
- Doses:
- 35500 and 39800 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: at intervals during the first six hours after dosing and daily thereafter up to the 14th day
- Necropsy of survivors performed: yes (adrenals, bladder, liver, spleen, stomach, kidneys, lungs, thymus, heart, small and large intestine)
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 39 800 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths were observed.
- Clinical signs:
- other: Most of the animals had diarrhea: 39800 mg/kg: 2/10 at 19 hours, 4/10 at 21 hours, 9/10 (2/10 slight degree) at 24 hours, 4/10 at 48 hours 35500 mg/kg: 10/10 within 22 hours through 24 hours, 3/10 slight degree at 48 hours
- Gross pathology:
- The following effects were observed:
39800 mg/kg:
bladder: 3/10 distended with urine
heart: 2/10 soft
kidneys: 4/10 (2/4 slight) hydronephrosis
lungs: 3/10 focal hemorrhage, 2/10 slightly congested
35500 mg/kg:
bladder: 2/10 (1/2 slight) distended with urine
heart: 5/10 (1/5 slight) soft
kidneys: 5/10 (1/5 slight) hydronephrosis
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
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