Registration Dossier

Diss Factsheets

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:
1982
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

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
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:
No signs of systemic toxicity observed
Body weight:
All rabbits regained pre-treatment weight within 1 week post  treatment.
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