Registration Dossier
Registration Dossier
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EC number: 500-029-3 | CAS number: 9049-71-2 1 - 16.5 moles propoxylated
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: 2d guideline study. Study was not conducted in conformance to GLP, but study was conducted on the basis of Federal Registry guidelines. 38: 27019
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Federal register, September 27, 1973, 38:27019
- 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
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ray Nicols Rabbitry, Lumberton, Texas
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 ml - Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- The backs of 6 rabbits were clipped free of hair with electric clippers 24 hours prior to use. Under a surgical gauze patch held in place with adhesive tape, 0.5 ml of the test material was applied to an intact and freshly abraded site on each rabbit. The patches were covered with a piece of heavy-gauge plastic film to retard evaporation and bandaged. After 24 hours, the patches were removed and each site was assessed; the severity of the reaction was recorded then , and at 72 hours from the beginning of the test.
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours
- Scoring system: no data (score range 0 - 8)
- Examination time points: at patch removal and 72 hours
from test beginning
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Time point:
- other: 24 hour
- Score:
- 0
- Max. score:
- 8
- Irritant / corrosive response data:
- No redness or swelling was observed on the skin of any of the 6 rabbits after 24 hours exposure to the test material. Therefore, the primary irritation score was 0 out of possible 8.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance was classified as "not irritating" on the basis of the scores which were 0 out of a possible 8.
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