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U.S. Department of Health and Human Services

Database of Select Committee on GRAS Substances (SCOGS) Reviews

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Report No.:  6
Type of Conclusion:  3
ID Code:  9000-07-1
Year:  1973
CFR Section:  172.620
SCOGS Opinion:  The available information on the oral administration of undegraded carrageenan at levels greatly exceeding the daily human intake, reveals evidence of possible adverse effects on the gastrointestinal epithelium. Extensive recent investigations of carrageenan and the pathogenesis of gastrointestinal changes indicates the susceptibility of the guinea pig to ulcerative colitis when fed relatively high levels of carrageenan in the diet. The work suggests that the occurrance of ulcers in the large bowl of animals is a species-specific phenomenon where feeding of carrageenan can induce ulceration in the caecum and proximal colon of the guinea pig which to date, does nto appear to occur n the rat, mouse, hamster, pig, squirrel monkey, or man. Recent reports on the oral administration of undegraded sodium and calcium carrageenan of known quality to pregnant animals reveals fetotoxic effects, with or without frank teratogenic effects, in some species at levels that do not greatly exceed the average daily human rate of intake. There effects appear to be dose-dependent. While carrageenan exhibites no mutagenic effects as measured by the host-mediated and dominant lethal assay procedures, significant abnormalities appear to be induced in the anaphase figures of human embryoic lung cells in tissue culture at dosages that are slightly above average daily human intake. It is of further concern that parenterally administered carrageenan is reported to inhibit the activity of complement, excert cytotoxic effects on macrophases, suppress delayed hypersensitivity reactions in some tuberculin sensitive animals, activate factors causing procoagulant activity in human blood platelets, increase vascular permeabiltiy, and liberate kinin in vitro, all of which point to the possibility of the generation of toxic effects that could cause adverse responses followint the oral consumption of carrageenan if, during pregnancy or in the presence of infectious challenge or metabolic disorder, appropriate amounts of carrageenan should be absorbed from the gastrointestinal tract. The Select committee has been informed that additional animal feeding and teratologic studis are soon to be initiated on commercial carrageenan and on several of the separated polysaccharide components of carrageenan. The Committee's opinion should be reviewed once the results of these studie become available. The Selct Committee has weighed the foregoing and concludes that: While no evidence in the available information on undegraded carrageenan demonstrates a hazard to the public when it is used at levels that are now current and in the manner now practiced, uncertainties exist requiring that additional studies should be conducted.