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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was not conducted in conformance to GLP and guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
- Principles of method if other than guideline:
- fixed dose procedure
- GLP compliance:
- not specified
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:
- Test substance: Sucrose, propoxylated (Supplier: DOW Texas Division in Freeport, Texas)
Lot TB 04239-350
Composition: Mixture of random polymers from the reaction products of sucrose and propylene oxide and of glycerine and propylene oxide.
Composition and Mol. weight not mentioned in the report however provided by the test matirial supplier for the purpose of the study summary:
70.4% Sucrose+PO and 29.6% Glycerol+PO
Average molecular weight: 720 g/mol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ray Nicols Rabbitry, Lumberton, Texas
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Shorn dorsal skin.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with mild soap and water - Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 4
- 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 signs, body weight,organ weights, histopathology, other:The topical response at the site of application was evaluated after patch removal. Animals were observed frequently during exposure and for the following two weeks for signs of toxicity.
Bodyweights were recorded on the day of dosing, thereafter and on days 7 and 14. At the end of the study all animals were subject to gross necropsy, macroscopic abnormalities were recorded.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No death
- Clinical signs:
- other: No signs of systemic toxicity observed
- Gross pathology:
- Slight to moderate petechial hemorrhages were observed in the subcutaneous fat and fascia at the application sites. Underlying muscle was not involved. The skin was viable and intact.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD 50 for the test substance is >5000 mg/kg bw
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