Registration Dossier
Registration Dossier
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EC number: 701-203-3 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Limited documentation (analytical purity of test substance not specified; 7-day observation period, no details on experimental results).
Data source
Reference
- Reference Type:
- publication
- Title:
- THE ORAL TOXICITY AND PATHOLOGY OF POLYETHOXYETHYLENE DERIVATIVES IN RATS AND HAMSTERS
- Author:
- Eagle, E. and Poling, C.E.
- Year:
- 1 956
- Bibliographic source:
- Food research 21: 348-361
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, 7-day observation period)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Sorbitan monooleate, ethoxylated
- EC Number:
- 500-019-9
- EC Name:
- Sorbitan monooleate, ethoxylated
- Cas Number:
- 9005-65-6
- Molecular formula:
- Not applicable as UVCB
- IUPAC Name:
- Sorbitan, C18-unsat, fatty acid esters, ethoxylated (1 - 6.5 moles ethoxylated)
- Reference substance name:
- Tween 80
- IUPAC Name:
- Tween 80
- Details on test material:
- - Name of test material (as cited in study report): Polyoxyethylene-20-sorbitan monooleate
- Analytical purity: no data
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 150-220 g
- Fasting period before study: animals were fasted for a period of 18 h, but received water ad libitum.
- Housing: each animal was kept in a separate cage in an air-conditioned animal room.
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25.6-27.8
- Humidity (%): 45
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Doses:
- several doses were applied (not specified) for determination of the median lethal dose
- No. of animals per sex per dose:
- 54 (in total; number of animals per dose not specified)
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes - Statistics:
- Calculation of LD50 was made by the method of Reed and Muench (1938).
REFERENCE:
Reed, L.J. and Muench, H. (1938). A simple method for estimating 50 percent endpoints. Am. J. Epidemiol. 27(3): 493-497
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 58 860 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: recalculated value for 54.5 mL/kg bw based on a density of 1.08 g/mL (20 °C)
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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