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Pharmacol Ther. 1996;71(1-2):225-52.

Saccharin mechanistic data and risk assessment: urine composition, enhanced cell proliferation, and tumor promotion.

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Toxicology and Risk Assessment Program, American Health Foundation, Valhalla, NY 10595-1599, USA.


Sodium saccharin (NaSac) produces bladder tumors consistently in male rats only after lifetime exposure that begins at birth. NaSac is not metabolized and is negative in most genotoxicity tests. NaSac-induced cell damage and proliferation have been proposed as important factors in tumor promotion, and dose-response information demonstrating a threshold for these parameters is available. One theory proposes that high levels of NaSac, combined with protein in a high Na+, high pH environment found only in the male rat, form toxic microscopic crystals; therefore, NaSac-induced tumors may not be relevant to human carcinogenesis.

[Indexed for MEDLINE]

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