Select Committee on GRAS Substances (SCOGS) Opinion: Distarch Oxypropanol
- SCOGS-Report Number: 115*
- Type Of Conclusion: 3
- ID Code: 977043-57-4
- Year: 1979
- 21 CFR Section:
Two modified starches, distarchoxy propanol and acetylated distarchoxy propanol are included in this group. Twenty-eight-day feeding studies with distarchoxy propanol prepared by treatment with up to the maximum permitted level of acrolein showed no adverse effect on weight gains, feed efficiencies or cecal weights when fed at relatively high levels (60 g per kg) compared to probable human consumption. Similar studies with acetylated distarchoxy propanol prepared by acetylation with vinyl acetate and crosslinking with acrolein showed a significant reduction in growth rate and a high incidence of diarrhea with products containing 3 percent or more acetyl groups. However, no adverse effects were observed on reproduction or lactation in dams or weight gains or feed efficiencies of the pups in a two-generation study of the acetylated derivative (2.5 percent acetyl groups) fed at a level of 45 g per kg to the weanling rats. Both generations were fed for 1 year. Thus it appears advisable to limit the acetyl content of these starches to 2.5 percent; this level is consistent with the permitted treatment with a maximum of 7.5 percent vinyl acetate. Some evidence indicates that acrolein, the cross-linking agent used in preparing distarchoxy propanols, is mutagenic indicating that residues of acrolein in the modified starches should be reduced to minimum feasible levels. Long-term feeding studies on distarchoxy propanols also are suggested since those conducted have been limited to 1 year duration and no histopathological or other examinations have been reported. However, it is understood that manufacture of these modified starches was discontinued several years ago.
In view of the foregoing the Select Committee concludes that:
While no evidence in the available information on distarchoxy propanol and acetylated distarchoxy propanol demonstrates a hazard to the public should they be used at former levels and in the manner formerly practiced, uncertainties exist requiring that additional studies should be conducted.