Chronic toxicity and carcinogenicity to the urinary bladder of sodium saccharin in the in utero-exposed rat

Taylor, Jean M.; Weinberger, Morris A.; Friedman, Leo

doi:10.1016/0041-008x(80)90008-3

Cited by 92 publications

(29 citation statements)

References 14 publications

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“…However, two studies that reported tumourigenic potential generated a lot of media interest and ultimately led to withdrawal of saccharin in Canada and a label warning on all food containing saccharin (Squire, 1985;Taylor et al, 1980). Taylor et al (1980), reported a significant increase in the incidence of neoplasms in F1 generation of male Charles River CD rats that received a 7.5% dietary concentration of saccharin.…”

Section: Long-term Carcinogenicity Studiesmentioning

confidence: 99%

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Toxicity of food colours and additives: A review

Thomas¹,

Adegoke²

2015

Afr. J. Pharm. Pharmacol.

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Majority of consumer goods are required to be presented with good aesthetics in order to improve acceptability in terms of colours and in some instances taste. When related to food, beverages and drug products, additives are usually added to mask un-inviting colours, obscure offensive odours and increase taste. Food additives therefore include colourants, sweeteners, preservatives and anti-caking agents. Admissible daily intake limits are often recommended for these additives. Being food products, the amount consumed over time may be subject to individual preferences and thus negating the desire to regulate and control the amount consumed cumulatively. There have been several concerns about the safety of food additives and several batteries of tests, and reports are available in literature. This review attempted to give an update on reports that have surfaced in literature over recent past on the use and safety of food colours and other additives. Some safety concerns have been related to three determinations; cytotoxicity, genotoxicity and induction or potential of inducing mutagenicity. In order to accomplish these targeted evaluations, several tests have been prescribed by International conference on harmonization (ICH), organization for economic co-operation and development (OECD) and European food safety authority (EFSA). It is observed that no single test can give a full proof of safety of these food colours and additives, hence minimal tests are recommended to be carried out in order to guarantee safety of these products. Survey of literature, revealed that once some approved additives or colours become a subject of safety concerns, comprehensive evaluations are carried out by researchers and these have often led to the de-classification of some hitherto reported agents as being non-genotoxic or non-carcinogenic. The declassifications of some food colors and additives as human carcinogens are regularly done following the comprehensive evaluation of results of mutagenicity and genotoxicity tests in vitro and some in vivo tests in mammalian tissues and whole animals. However, such declassifications are often done with caution and the implication is that regular and more comprehensive tests must be carried out. In addition, the requirements of testing for chronic exposures to this and other agents must be emphasized to prevent occurrence of subtle yet terrible side effects resulting from consuming sub-toxic doses of the additives over time.

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Section: Long-term Carcinogenicity Studiesmentioning

confidence: 99%

“…Taylor et al (1980), reported a significant increase in the incidence of neoplasms in F1 generation of male Charles River CD rats that received a 7.5% dietary concentration of saccharin. A subsequent report by Squire (1985) also found sodium saccharin related increase in the incidence of urinary bladder hyperplasia.…”

Section: Long-term Carcinogenicity Studiesmentioning

confidence: 99%

Toxicity of food colours and additives: A review

Thomas¹,

Adegoke²

2015

Afr. J. Pharm. Pharmacol.

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“…However, there is no compelling evidence that the levels of impurities normally found in commercial saccharin (66) contribute to the observed carcinogenicity of saccharin. The fact that several batches of RemsenFahlberg-produced saccharin were used in the twogeneration WARF (6) and FDA (7,8) studies, while Maumee-produced saccharin was used in the HPB study (4), would support such a conclusion. If an impurity were responsible for the carcinogenic effect of saccharin, it would have to be an extremely potent bladder carcinogen.…”

Section: Discussionmentioning

confidence: 75%

“…An interim report was presented at the annual Society of Toxicology meeting in 1974 (7), but a final report did not appear until 1980 (8).…”

Section: Toxicology Studiesmentioning

confidence: 99%

“…The most recent tempest was precipitated by the findings of a two-generation chronic bioassay which *Toxicology Research Division, Health Protection Branch, Health and Welfare Canada, Ottawa, Canada. has been dubbed the Canadian Saccharin Study (4). This study, which was the third to use the twogeneration bioassay model suggested by the late Dr. Leo Friedman (5), had followed similar saccharin studies conducted at the Wisconsin Alumni Research Foundation (WARF) (6) and at the U.S. Food and Drug Administration (FDA) (7,8). The ensuing controversy gave rise to the publication of at least two books (9,10), numerous articles in the popular literature, a plethora of scientific activity, a large media blitz by several trade associations, as well as the convening of various panels and conferences to evaluate and discuss the human consumption of saccharin in light of these experimental results (11)(12)(13)(14)(15)(16)(17)(18).…”

Section: Introductionmentioning

confidence: 99%

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Two-generation saccharin bioassays.

Arnold¹

1983

Environ Health Perspect

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The controversy regarding the safety of saccharin for human consumption started shortly after its discovery over 100 years ago and has yet to subside appreciably. The consumption of saccharin, particularly in North America, began to escalate when the U.S. Food and Drug Administration set new standards of identity which allowed foods containing artificial sweeteners to be promoted as "nonnutritive" or "noncaloric" sweeteners for use by the general public. In 1969, when cyclamates were banned, at least 10 single-generation feeding studies were undertaken with saccharin to more accurately assess the potential toxicological consequences resulting from the anticipated increase in its consumption. None of these studies resulted in any overt regulatory action. Subsequently, the introduction of the two-generation chronic toxicity/carcinogenicity bioassay added a new tool to the toxicologist's arsenal. Three two-generation studies using saccharin have since been conducted. The results from these studies clearly show that when rats were exposed to diets containing 5 or 7.5% sodium saccharin from the time of conception to death, an increased frequency of urinary bladder cancers was found, predominantly in the males. While some study results suggested that impurities in commercial saccharin or the presence of urinary tract calculi may have been responsible for the observed bladder tumors, it now appears that these possibilities are highly unlikely. The mechanism by which saccharin elicited the bladder tumors using the two-generation experiment has not been ascertained.

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Carbohydrate and Intense Sweeteners

O'Donnell¹

2004

Chemistry and Technology of Soft Drinks and Fruit Juices

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Chronic toxicity and carcinogenicity to the urinary bladder of sodium saccharin in the in utero-exposed rat

Cited by 92 publications

References 14 publications

Toxicity of food colours and additives: A review

Toxicity of food colours and additives: A review

Two-generation saccharin bioassays.

Carbohydrate and Intense Sweeteners

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