Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Duration of exposure:
24 hours
Doses:
20 mL/kg
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
A limit dose of 20 mL/kg was applied to the akin after the hair was removed from the skin with an electric clipper. An occlusive wrap was used to hold the test material against the skin for 24 hours, and at the end of exposure, residual test material was washed off with running water. No abnormal clinical signs or signs of irritation at the site of application of the test material were observed during the 14-day observation period. All animals gained weight normally, and based on weight gain and survival rate, no signs of percutaneous absorption were evident.

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
none
Body weight:
all animals gained weight normally
Gross pathology:
none

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The acute dermal LD50 for SAIB was determined to be > 20000 mg/kg in male and female Sprague Dawley rats.
Executive summary:

The acute dermal toxicity of sucrose diacetate hexaisobutyrate (SAIB) was evaluated in Sprague Dawley rats. A limit dose of 20 mL/kg was applied to the skin after the hair was removed from the skin with an electric clipper. An occlusive wrap was used to hold the test material against the skin for 24 hours, and at the end of exposure, residual test material was washed off with running water. No abnormal clinical signs or signs of irritation at the site of application of the test material were observed during the 14-day observation period. All animals gained weight normally, and based on weight gain and survival rate, no signs of percutaneous absorption were evident. The acute dermal LD50 for SAIB was determined to be > 20000 mg/kg.