Select Committee on GRAS Substances (SCOGS) Opinion: Acetylated Distarch Adipate
Acetylated Distarch Adipate
- SCOGS-Report Number: 115*
- Type Of Conclusion: 2
- ID Code: 63798-35-6
- Year: 1979
- 21 CFR Section: 172.892
Studies with radio-labeled acetylated distarch adipate in the rat showed that adipic acid entered the metabolic pool more slowly but followed normal pathways for free adipic acid. Body weight gains were about 15 percent lower than controls, but no significant pathological changes were observed in 90-day and 2-year rat feeding studies at dietary levels of 40 and 30 g per kg body weight, respectively. Kidney lesions, characterized by focal hyperplasia of the epithelium lining the urinary space accompanied by calcified deposits in the lining of the epithelium, were observed in both treated and control animals but there was no significant difference in severity or frequency of the lesions h the two groups. The Select Committee considers these lesions to be of doubtful biological importance but suggests that studies be undertaken in due time to determine their toxicological significance. Cecal enlargement occurred in both feeding studies but without associated histopathological change and is considered to have no toxicological significance.
Based on the foregoing evidence, the Select Committee concludes that:
There is no evidence in the available information on acetylated distarch adipate 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.