Select Committee on GRAS Substances (SCOGS) Opinion: Acetylated Distarch Phosphate
Acetylated Distarch Phosphate
- SCOGS-Report Number: 115*
- Type Of Conclusion: 2
- ID Code: 68130-14-3
- Year: 1979
- 21 CFR Section: 172.892
Although in vitro rate of digestion of acetylated distarch phosphate by pancreatin or porcine intestinal amylase was less than that of unmodified starch, this was not reflected in growth rate or feed efficiency-in animals fed diets containing high levels of this starch derivative. Slight diarrhea and increased cecal weights were noted in short-term rat feeding experiments at a dietary level of 60 g per kg body weight, an intake level much greater than the highest indicated current consumption levels. No cecal tissue changes were observed. No significant effects related to treatment with the possible exception of a renal alteration were observed in long-term rat feeding studies of acetylated distarch phosphate and acetylated diamylopectin phosphate. The former derivative was acetylated with acetic anhydride and the latter with vinyl acetate. The renal alteration consisted mainly of focal hyperplasia of the renal papillary and pelvic epithelium accompanied by calcified patches in the underlying tissues. There was not a distinct relationship between incidence of lesions and feeding level for either acetylated distarch phosphate or acetylated diamylopectin phosphate. The toxicological slgnificance of this renal alteration needs clarification.
On the basis of the foregoing, the Select Committee concludes that:
There is no evidence in the available information on acetylated distarch phosphate 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.