Sucrose, mixed acetate and isobutyrate octaesters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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 401 (Acute Oral Toxicity)

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

Route of administration:

oral: gavage

Vehicle:

corn oil

Doses:

5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

not specified

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: Diarrhea was observed during the day of dosing, which resolved within 1-2 days of dosing

Gross pathology:

none

Other findings:

The test article was, at most, slightly toxic by the oral route. After administration of a limit dose of 5000 mg/kg, treatment related signs were restricted to diarrhea on the day of and/or the day following administration of the teat material. The diarrhea was most likely due to the corn oil used in the dosing preparation. By Day 2 of the study, all animals appeared normal. All animals survived the scheduled 14-day observation period and gained weight normally. No treatment-related changes were observed at necropsy , andd no tissue was collected for microscopic examination.

Applicant's summary and conclusion

Conclusions:

The test material, sucrose diacetate hexaisobutyrate (SAIB), was at most slightly toxic by the oral route when administered to rats at a dose of 5000 mg/kg, and thus, the acute oral LD50 was determined to be >5000 mg/kg.

Executive summary:

The test article was, at most, slightly toxic by the oral route. After administration of a limit dose of 5000 mg/kg, treatment related signs were restricted to diarrhea on the day of and/or the day following administration of the teat material. The diarrhea was most likely due to the corn oil used in the dosing preparation. By Day 2 of the study, all animals appeared normal. All animals survived the scheduled 14-day observation period and gained weight normally. No treatment-related changes were observed at necropsy , andd no tissue was collected for microscopic examination.