Carcinogenicity studies

Abbott Laboratories, which has conducted additional toxicity and carcinogenicity studies with cyclamate, a 10 1 mixture of cyclamate—saccharin, and cyclohexylamine, claimed to be unable to confirm the 1969 findings. Abbott then filed a food additive petition for cyclamate in 1973, which was denied by the FDA in 1980. In 1982, the Calorie Control Council and Abbott Laboratories filed a second food additive petition containing the results of additional safety studies (73). That petition was stiU pending as of 1996. Cyclamate is, however, allowed for use in any or all three categories, ie, food, beverage, and tabletop, in about 50 countries. Sweet n Low, known in the United States as a saccharin-based table-top sweetener, contains exclusively cyclamate in Canada. 

Sodium chlorite is not Hsted by the USEPA or any regulatory authority as a carcinogen. Studies conducted ia mice and rats did not show an increase in tumors in animals exposed to sodium chlorite in thek drinking water. Sodium chlorite has been found to have mutagenic activity in some in vitro test systems such as the Ames Salmonella reverse mutation assay without the presence of metaboHc activators. The significance of these test results in regard to human health is not clear because of the oxidizing effects of the chlorite ion (149). 

S1A Need for Carcinogenicity Studies of Pharmaceuticais S1B Testing for Carcinogenicity of Pharmaceuticals... 

S1 C(R1) Dose Selection for Carcinogenicity Studies of Pharmaceuticals Limit Dose S2A Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals S2B Genotoxicity A Standard Battery for Genotoxicity Testing of Pharmaceuticals Toxicokinetics and Pharmacokinetics... 

GL28 Safety carcinogenicity Studies to evaluate the safety of residues of veterinary drug in human food carcinogenicity testing... 

Ciba-Geigy Ltd (1986) 24 month carcinogenicity study in rats. Final report TK 12700/1. Basel, Ciba-Geigy Ltd, 2 January (GU Project No. 800218). 

Hack R, Ebert E, Leist KH. 1995. Chronic toxicity and carcinogenicity studies with the insecticide endosulfan in rats and mice. Eood Chem Toxicol 33(11) 941-50. 

Hoechst. 1988e. Endosulfan - Substance Technical (Code HOE 002671 01ZD97 0003)/ Carcinogenicity study in mice 24 month feeding study. Hoechst Celanese Corporation, Somerville, New Jersey (author HH Donaubauer). TOXN NO. 83.0113 (Volume 1 of 13). April 6,1988. [unpublished study]... 

NCI. 1968. Evaluation of carcinogenic, teratogenic and mutagenic activities of selected pesticides and industrial chemicals. Volume I Carcinogenic study. Prepared by Bionetics Research Labs, Inc., Bethesda, MD National Cancer Institute. NCI-DCCP-CG-1973-1-1. 

Henschler D, Romer W, Elasser HM, et al. 1980. Carcinogenicity study of trichloroethylene by long-term inhalation in three animal species. Arch Toxicol 43 237-248. 

Henschler D, Elsasser H, Romer W, et al. 1984. Carcinogenicity study of trichloroethylene, with and without epoxide stabilizers, in mice. J Cancer Res Clin Oncol 107 149-156. 

Pott, F., Ziem, U., Reiffer, F.J., Huth, F., Ernst, H. and Mohr, U. (1987). Carcinogenicity studies on fibres, metal compounds and some other dusts in rats. Exp. Pathol. 82, 129-152. 

Polyalphaolefin Hydraulic Fluids. Because no chronic-duration human or animal inhalation, oral, or dermal exposure studies using polyalphaolefin hydraulic fluids were located, chronic-duration inhalation or oral MRLs could not be derived. Systemic toxicity studies in which animals were exposed via inhalation, oral, and dermal routes would be useful in identifying the end points of toxicity for humans living at or near hazardous waste sites and exposed for chronic durations. Further carcinogenicity studies on individual organophosphate ester components of hydraulic fluids maybe useful. 

Results from this preliminary study suggest that a combined approach based on alternative methods could be positively applied to chemical screening in order to reduce the number of animal testing for carcinogenicity studies. 

Bio/dynamics. 1980a. A twenty-four month oral toxicity/carcinogenicity study of acrylonitrile administered to Spartan rats in the drinking water. Biodynamics, Inc., Division of Biology and Safety Evaluation, East Millstone, NJ. Project No. BDN-77-28. 

PAH radical cations are also involved in the metabolic conversion of PAH to PAH diones. Carcinogenicity studies of PAH in rat mammary gland indicate that only PAH with ionization potential low enough for activation by one-electron oxidation induce tumors in this target organ. These results and others indicate that one-electron oxidation of PAH is involved in their tumor initiation process. 

Parent, R.A., H.E. Caravello, and J.E. Long. 1992. Two-year toxicity and carcinogenicity study of acrolein in rats. Jour. Appl. Toxicol. 12 131-139. 

---