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Toxicological information

Skin irritation / corrosion

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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:
1982
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

Constituent 1
Chemical structure
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

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.