Registration Dossier
Registration Dossier
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EC number: 500-029-3 | CAS number: 9049-71-2 1 - 16.5 moles propoxylated
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 1a guideline study. Study was conducted in accordance to GLP and OECD guideline 401.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
Test material
- Reference substance name:
- Sucrose, propoxylated
- EC Number:
- 500-029-3
- EC Name:
- Sucrose, propoxylated
- Cas Number:
- 9049-71-2
- Molecular formula:
- C12H14O11-(C3H6O)nH8 sum of n: >1 - <16.5 mol PO
- IUPAC Name:
- Sucrose, propoxylated
- Details on test material:
- Substance: Polyether 4034 B
Lot no.: 77
Product name: CS-Nr. 75521/Polyether 4034B
Substance Composition: 90 %b.w. Sucrose-PO polyether , 10 %b.w. MPG-PO polyether
average molecular weight: 630 g/mol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, Borchen, Germany
- Age at study initiation: 6 - 9 weeks
- Weight at study initiation: males 182 g; females 156 g
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2 C
- Humidity (%): 55 + 5 %
- Photoperiod (hrs dark / hrs light): 12 hours light and dark period
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 ml/kg bw
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical observations were made several times on the day of dosing and at least once a day during the 14 day observation period. Bodyweights were recorded immediately prior to dosing and on days 7, and 14. Gross pathological examination was carried out on all animals.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No death
- Clinical signs:
- other: No Signs
- Gross pathology:
- None identified
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 for test substance in male and female Wistar rats is >2000 mg/kg bw. No adverse effects were observed at this dose level.
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