Sucrose, mixed acetate and isobutyrate octaesters

Endpoint summary

Additional information

Ocular Irritation Study in Rabbits

The test article, sucrose acetate isobutyrate (SAIB) was evaluated for its potential to induce ocular irritation in rabbits. The physical characteristics of SAIB, as received, made it unsuitable for dosing in this study. A solution was prepared by dissolving 1.0 gram of the test article in 1.0 mL of corn oil and warming the solution to 32° C. The solution was administered at a volume of 0.1 mL/eye, to each of the six eyes (3 unwashed, 3 washed) utilized in this study. An additional eye (unwashed) was dosed with 0.1 mL of corn oil to serve as a control. In the control eye, no signs of irritation were observed during the 72-hour observation period. When tested with fluorescein dye 24 hours after dosing, no adnexal or corneal staining was noted. The test ardcle was a slight eye irritant when administered as a 50% solution in corn oil. In unwashed eyes, signs of irritation were limited to moderate erythema of the conjunctivae and nictitating membranes one hour after administration of the test material. At the 24-hour observation period, one of three unwashed eyes appeared normal and slight erythema of the conjunctivae and nictitating membranes were noted in the remaining two eyes. When tested with fluorescein dye 24 hours after dosing, there was no adnexal or corneal staining in the unwashed eyes. By 48 hours, two of three eyes were normal and by 72 hours, all unwashed eyes appeared clinically normal. Immediate washing reduced the duration of irritation were restricted to slight erythema of the conjunctivae and nictitating membranes at the one-hour observation period. At 24 hours, all washed eyes appeared normal and no corneal or adnexal staining was observed when the eyes were tested with fluorescein dye.

Dermal Irritation Study in Guinea Pigs

A dose of 0.5 mL of Sucrose Acetate Isobutyrate (SAIB) was applied to each depilated abdomen of 5 guinea pigs, and an occlusive wrap was used to hold the test material against the skin for 24 hours. No signs of irritation were observed over 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.