Select Committee on GRAS Substances (SCOGS) Opinion: Starch Acetate
- SCOGS-Report Number: 115*
- Type Of Conclusion: 2
- ID Code: 9045-28-7
- Year: 1979
- 21 CFR Section: 172.892
Although the in vitro rate of digestion of acetylated starches is lower than that of the corresponding unmodified starch, no difference in digestibility was found in rat feeding experiments with starches containing 2 percent acetyl groups which is near the maximum permitted level of 2.5 percent. No adverse effects were observed in short-term animal feeding studies except for enlargement of the ceca and slight diarrhea in some studies at high intake levels (50 g per kg body weight). Cecal enlargement also was observed in long-term feeding studies with rats and mice but, as in the short-term studies, no cecal tissue abnormalities were found and the enlargement is not considered a significant finding. No adverse effects were noted in fertility, litter size, resorption quotient, preweaning mortality or growth rate of pups in a three-generation rat feeding study of starch acetate. In the 2-year feeding study, suburothelial deposits of calcium accompanied by hyperplasia of the epithelium lining the renal pelvis occurred slightly more frequently in test males at the highest treatment level than in control animals. Slightly increased inc idence of intratubular nephrocalcinosis and concrements in the renal pelvic space of males were observed in a 79-week mice feeding study but hyperplasia did not occur. The toxicological significance of the renal changes observed in these studies needs clarification. This modified starch is not currently used in infant foods.
Based on the foregoing considerations, the Select Committee concludes that:
There is no evidence in the available information on starch acetate that demonstrates or suggests reasonable grounds to suspect a hazard to the public when it is used at levels that are now current and in the manner now practiced. However, it is not possible to determine, without additional data, whether a significant increase in consumption would constitute a dietary hazard.