Select Committee on GRAS Substances (SCOGS) Opinion: Propylene glycol alginate
Propylene glycol alginate
- SCOGS-Report Number: 24*
- Type Of Conclusion: 2
- ID Code: 9005-37-2
- Year: 1973
- 21 CFR Section: There is no CFR citation.
The available information on the alginates reveals no significant adverse toxicological effects from oral administration in non-pregnant animals or humans in daily amounts greatly exceeding those currently consumed in the diet. However, in pregnant mice, very large doses of propylene glycol alginate, while not teratogenic, cause a significant increase in maternal mortality. Such increased maternal toxicity does not occur at a dose of propylene glycol alginate which is 26-fold or more greater than that estimated to be the average daily adult dietary intake. No respect but studies of propylene glycol, made by the same investigators and is without maternal toxicity even at very large doses. This indicates that the adverse effects reported for propylene glycol alginate may be due to the alginate moiety. It is noteworthy that similar toxic effects have been observed in identical tests on a large number of other polysaccarides (gum arabic, sterculia gum, carob bean gum, guar gum, gum ghatti, gum tragacanth, carrageenan, methyl cellulose, and agar-agar) fed at very high levels. The relative sensitivity of the several animal species to these effects, varies depending on the particular polysaccaride tested, but in all cases very large doses are required. Until these effects have been adequately explained, it appears to be inappropriate to conclude that unrestricted use of such substances in food would be without hazard. The Select Committee has weighed all of the foregoing and concludes that: There is no evidence in the available information on ammonium, calcium, potassium, sodium, and propylene glycol alginates that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when they are 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 of these substances would constitute a dietary hazard.