Studies to evaluate artificial sweeteners, especially Remsen--Fahlberg saccharin, and their possible impurities, for potential mutagenicity by the Salmonella/mammalian liver microsome test.
Cyclamate, cyclohexylamine, saccharin, boiled saccharin, 3 organic extracts of this sweetener and 9 possible impurities, including OTS and PTS, were evaluated for potential mutagenic activity by the Salmonella/mammalian liver microsome test on Salmonella typhimurium TA1535, TA100, TA1537 and TA98 (extracts only on TA98) with doses up to at least 2500 micrograms per plate with and without metabolic activation. No mutagenic activity was established either for cyclamate, cyclohexylamine or saccharin, or for some of the possible impurities of saccharin synthesized by the Remsen--Fahlberg or Maumee process. Only 1 organic extract gave inconclusive results in 3 consecutive experiments. No mutagenic activity was noted for saccharin refluxed for 2 h in solution.
D000818:Animals; D001711:Biotransformation; D004305:Dose-Response Relationship, Drug; D008297:Male; D008862:Microsomes, Liver / Q000378:metabolism*; D009152:Mutagenicity Tests; D009153:Mutagens; D009154:Mutation; D051381:Rats; D011919:Rats, Inbred Strains; D012439:Saccharin / Q000494:pharmacology*; D012486:Salmonella typhimurium / Q000187:drug effects; D013329:Structure-Activity Relationship; D013549:Sweetening Agents / Q000494:pharmacology*
D009153:Mutagens; D013549:Sweetening Agents; D012439:Saccharin