Sucrose, mixed acetate and isobutyrate octaesters

Acute Toxicity: dermal

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

Guideline:

OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sucrose di(acetate) hexaisobutyrate

EC Number:

204-771-6

EC Name:

Sucrose di(acetate) hexaisobutyrate

Cas Number:

126-13-6

IUPAC Name:

Sucrose Acetate Isobutyrate

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 levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 20 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 20 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: none

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.