Fact sheet: the Report on Carcinogens - 9...( a substance in the Report is not a regu...)

a substance in the Report is not a regulatory action, but listing may prompt regulatory agencies to consider limiting exposures or uses of a substance. In addition, the U.S. Congress, Federal and State Agencies, businesses, unions and the general public all use the Report to ensure that reasonable precautions or regulations are in place.

The following briefly describes the additions and/or changes made to the 9th edition of the Report:

• Saccharin - Saccharin has been removed from the 9th edition. The Calorie Control Council nominated saccharin for delisting, which led to a new review of the carcinogenicity data for saccharin. Saccharin had been listed in the Report as "reasonably anticipated to be a human carcinogen" since 1981. The basis for this listing was sufficient evidence of carcinogenicity in experimental animals. Saccharin was removed from the Report after this extensive review determined that the rodent cancer data are not sufficient to meet the current criteria to list this chemical in the Report as a "reasonably anticipated human carcinogen." This is based on the determination that the observed bladder tumors in rats arose from a mechanism that is not relevant to humans.

  Dr. Kenneth Olden, Director of the National Institute of Environmental Health Sciences and the National Toxicology Program, said, "Two decades ago, when saccharin was shown to produce bladder tumors in rats, it was a prudent, protective step to consider the sweetener to be a likely human carcinogen. However, our understanding of the science has advanced and allows us to make finer distinctions today. Studies now indicate that the rat bladder tumors arise from mechanisms that are not relevant to the human situation. In addition, we have decades more data from observations of humans using saccharin that adds to our confidence. In other words, with better science we can now make a better call."

• Ethyl acrylate - Ethyl acrylate, a substance used in ma
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Contact: Sandra Lange
lange@niehs.nih.gov
919-541-0530
NIH/National Institute of Environmental Health Sciences
14-May-2000


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