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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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 levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
Diarrhea was observed during the day of dosing, which resolved within 1-2 days of dosing
Body weight:
All rats gained weight at a normal rate
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.