The GRAS Substances (SCOGS) Database allows access to opinions and conclusions from 115 SCOGS reports published between 1972-1980 on the safety of over 370 Generally Recognized As Safe (GRAS) food substances. The GRAS ingredient reviews were conducted by the Select Committee in response to a 1969 White House directive by President Richard M. Nixon.
- SCOGS-Report Number: 25*
- Type Of Conclusion: 2
- ID Code: 9004-67-5
- Year: 1973
- 21 CFR Section: 182.1480
Cellulose is a major constituent of many foods of plant origin. As such it is a significant portion of the diet, but is neither degraded nor absorbed. Cellulose derivatives considered in this report are virtually unabsorbed and little or no degradation of absorbed and little or no degradation of absorbable products occurs in the human digestive tract. In man, consumption of large amounts appears to have no effect other than providing dietary bulk, reducing the nutritive value of such foodstuffs and possibly exerting a laxative effect. However, the existence of certain data and the different categorization of cellulose and the several cellulose derivatives on the GRAS list suggest that the Select Committee should render a separate opinion on each substance considered in this report.
B. METHYL CELLULOSE
In humans, virtually 100 percent of orally ingested methyl cellulose can be recovered in the feces withihn four days, indicating that absorption does not occur. However, in pregnant mice, very high doses of methyl cellulose, while not teratogenic, cause a significant increase in maternal mortality and retardation of fetal maturation. Such increased maternal and fetal toxicity does not occur at a dose of methyl cellulose which is 26-fold (or more) greater than that estimated to be the average daily adult dietary intake. It is noteworthy in this regard that similar toxic effects have been observed in identical tests performed by the same investigators on a large number of other polysaccharides fed at very high doses. The relative sensitivity of the several animal species to these effects varies, depending on the particular polysaccharide 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.
In the light of the foregoing, the Select Committee concludes that:
There is no evidence in the available information on methyl cellulose 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.
*Complete reports containing details of the safety studies that formed the basis of the opinions and conclusions and are available from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161 (703) 605-6000.