Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

13-Week Oral (Dietary) Feeding Study in Rats

This experiment was designed to evaluate the potential subchronic toxicity of Sucrose acetate isobutyrate (SAIB) in rats following oral dietary administration. A total of 80 rats were divided into four groups, 10 males and 10 females in each group. Rats no. 1-20 served as the control groups, while rats no. 21-40, 41-60, and 61-80 were fed diets containing 0.38%, 1.88%, and 9.38% SAIB, respectively. After 13 weeks the rats were killed with ether and organs were collected, weighed, and evaluated histologically.

The rats which were treated with up to 9.38 % SAIB in the feed (which in addition contained 9.38 per cent vegetable oil) showed no specific tissue changes in kidneys, liver, bone marrow, spleen, gonads and adrenals through histological examinations. The very slight vacuolization of liver cells, which was shown in some of the control and treated animals can possibly be caused by the feeding of all the rats with 9.38 % vegetable oil, the solvent for SAIB.


One-year Oral (Dietary) Feeding Study in Rats

This study was conducted to assess the chronic toxicity of sucrose acetate isobutyrate (SAIB) when administered to rats in their diet for at least 52 weeks. Twenty animals/sex/group were given 0, 0.5, 1, or 2 g SAIB/kg body weight/day (g/kg) in the basal diet for 52 weeks. Physical examinations and body weight and food consumption measurements were done weekly. Ophthalmic examinations were done before the initiation of treatment and during Weeks 26 and 52. Hematology and clinical chemistry tests were done on 10 animals/sex before initiation of treatment and hematology, clinical chemistry, and urinalysis tests were done on all surviving animals during Weeks 27 and 53. A bromsulphalein liver clearance test was done on all surviving animals in the control and 2-g/kg dose groups during Weeks 23 and 48. Necropsies were done on the 10 animals/sex bled for clinical pathology tests before initiation of treatment, on all animals that died or were sacrificed in a moribund condition, and on all surviving animals during Week 53. Tissues were collected and preserved from all animals and examined microscopically from animals in the control and 2-g/kg dose groups and all animals that died or were sacrificed in a moribund condition. Kidneys, liver, lungs, and all macroscopic lesions collected were examined microscopically from all animals. There were no test material-related antemortem observations, effects on clinical pathology variables or the bromsulphalein clearance test, or macroscopic or microscopic anatomical pathology changes. Body weights, cumulative body weight gains, and food consumptions for females given 2 g/kg SAIB were lower than those of the controls throughout the study and body weights for females given 0.5, 1, or 2 g/kg were 6%, 10%, and 7% lower, respectively, than those of the control group at Week 52. Higher organ-to-body weight percentages for the brain and heart corresponding to lower terminal body weights were also seen for this group. Males given 2 g/kg also had slightly lower body weights and cumulative body weight gains. Based on the results of this study, the no-observable-effect level for SAIB when administered to rats in their diets for 52 weeks is 1 g/kg body weight/day for females and greater than 2 g/kg body weight/day for males.

90-Day Oral (Dietary) Feeding Study in Dogs

SAIB was administered to dogs by incorporating it in their diet over a 3-rnonth period. Three dosage levels, 0, 0. 20, 0, 60, and 2. 00 per cent; were fed and comparisons made with controls fed the basal diet, all diets being adjusted to contain 12 per cent fat. After initial weight losses in all groups, the animals regained the weight and resumed growth or remained stabilized at approximately their 3 -week weights. Food consumption was unimpaired. Hematological examinations terminally, revealed no abnormalities in any of the parameters examined. Blood glucose and urea nitrogen levels were unaffected. Serum alkaline phosphatase values showed slight but significant increases at the 2.00 % level. Urinary examinations at the same time period revealed no adverse findings. The absolute and organ to body weight ratios of 8 organs (ie., liver kidneys, spleen, brain, gonads, adrenals, thyroids, and pituitary) disclosed no significant differences among the groups except in the liver, in which organ significant elevations in weight were noted at the two higher dosage levels. Neither the gross observations made at necropsy, nor the histological findings in 24 tissues and organs of the control and 2.00 per cent level groups, and of the liver and kidneys of the 0.20 and 0.60 per cent levels, revealed any dose-related abnormalities. It is of interest to note that the microscopic findings failed to confirm any cause for the elevated alkaline phosphatase values or the increased liver weights of the high dosage level dogs.

90-Day Oral (Dietary) Feeding Study in Dogs

Sucrose acetate isobutyrate (SAIB) is manufactured by Tennessee Eastman Company Division at Kingsport, Tennessee, and has potential uses as a food packaging rna terial and a suspending agent for certain flavorings in soft drinks. This study was done to further investigate the increased liver weights, alkaline phosphatase levels and decreased Indocyanine Green clearance rates reported in previous dog studies. Ten male, beagle dogs were randomly d:ivided into two groups of five dogs each. One group was designated

the experimental group and fed 5.0% SAIB in the diet for 91 days. The other group served as the control group.

There was no significant difference in the body weight or feed consumption between the experimental and control animals. Mean hematocrit, hemoglobin and white blood cell count, triglycerides, glucose and bilirubin also were comparable between the experimental and control animals. Significant changes in serum alkaline phosphatase, a definite prolongation of indocyanine green clearance by the liver were observed in the experimental animals when compared to the control dogs. Mean organ weights for liver and kidney were determined, and the absolute and relative liver weights of the experimental dogs were significantly (p = 0.05) higher than the control weights whereas there was no difference observed in the absolute and relative kidney weights. Liver tissue examined microscopically for increased glycogen was normal, and no histologic evidence of abnormality attributable to the feeding of 5.0% SAIB in the diet was seen in any of the tissues examined. These data suggest that these effects of SAIB on the liver are functional in nature and reversible when the compound is withdrawn from the diet.

Justification for classification or non-classification