Toxicological Research

"Saccharin has been the subject of extensive scientific research. It is one of the most studied ingredients in the food supply. Although the totality of the available research indicates saccharin is safe for human consumption, there has been controversy over its safety. The basis for the controversy rests primarily on findings of bladder tumors in some male rats fed high doses of sodium saccharin.

Considerable saccharin research, however, indicates safety at human levels of consumption. The average user of saccharin ingests less than one ounce of the sweetener each year.

The scientific data supporting saccharin's safety include the following:

  • Extensive research on human populations has established no association between saccharin and cancer. More than 30 human studies have been completed and indicate saccharin's safety at human levels of consumption. In 14, single-generation animal studies involving several species of animals, saccharin was not shown to induce cancer in any organ, even at exceptionally high dose levels.
  • Saccharin is not metabolized (it passes through the body unchanged) and does not react with DNA (nucleic acid present in all living cells), meaning that saccharin lacks two of the major characteristics of a classical carcinogen.
  • Saccharin is approved in more than 100 countries around the world and has been reviewed and determined safe by the Joint Expert Committee on Food Additives (JECFA) of the World Health Organization and the Scientific Committee for Food of the European Union. Based on current research, JECFA recently doubled the ADI (acceptable daily intake) for saccharin. JECFA noted that the animal data which earlier raised questions about saccharin are not considered relevant to humans.” Information from


Long term toxicity study with orthotoluene-sulfonamide and saccharin. Arnold, D. L. et al. (1977) , Toxicol. Appl. Pharmacol., 41, 164, abstract No. 78

Long-term toxicity of orthotoluene- sulfonamide and sodium saccharin in the rat. Arnold, D. L. et al. (1980) , Toxicol. Appl. Pharmacol., 52, 113

Carcinogenicity of saccharin in laboratory animals and humans: letter to Dr. Harry Conacher of Health Canada. Bell W, et al., Int J Occup Environ Health. 2002 Oct-Dec;8(4):387-93.

The male rat carcinogens limonene and sodium saccharin are not mutagenic to male
Big Blue rats
., Turner SD, et al., Mutagenesis. 2001 Jul;16(4):329-32.

Long-term feeding of sodium saccharin to nonhuman primates: implications for
urinary tract cancer
Takayama S, et al., J Natl Cancer Inst. 1998 Jan 7;90(1):19-25.

Saccharin mechanistic data and risk assessment: urine composition, enhanced cell
proliferation, and tumor promotion
Whysner J, et al.,Pharmacol Ther. 1996;71(1-2):225-52. Review.

Cell proliferation in the bladder and implications for cancer risk assessment. Cohen SM, Toxicology. 1995 Sep 1;102(1-2):149-59. Review.

Effect of sodium saccharin on the neonatal rat bladder. Cohen SM, et al.,University of Nebraska Medical Center, Department of Pathology and Microbiology, Omaha, Nebraska, 68198, USA. Scanning Microsc 1995 Mar;9(1):137-47; discussion 148

Human relevance of animal carcinogenicity studies. Cohen SM. Regul Toxicol Pharmacol. 1995 Feb;21(1):75-80; discussion 81-6. Review.

The health risks of saccharin revisited. Ellwein LB and Cohen SM, Crit Rev Toxicol. 1990;20(5):311-26. Review.

Study of sodium saccharin co-carcinogenicity in the rat. West RW, et al.. Food Chem Toxicol. 1994 Mar;32(3):207-13.

Estimates of the risk of bladder tumor promotion by saccharin in rats. Gaylor DW, et al., Regul Toxicol Pharmacol. 1988 Dec;8(4):467-70.

Saccharin: past, present, and future. Cohen SM,J Am Diet Assoc. 1986 Jul;86(7):929-31.

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Page last updated: 2/23/05