Chronic toxicology carcinogenicity

The research program has a tiered approach starting from the acute profile up to the most important studies such as chronic toxicology, carcinogenicity, and reproductive studies. 

Pyridine Chronic Toxicology. AH mutagenicity tests have been negative and (1) is not considered a carcinogen or potential carcinogen. There have been no reports of adverse health effects on long-term exposure to (1) at low concentrations. 

Indicators of toxicity hazards include LD50, LC50, plus a wide range of in vitro and in vivo techniques for assessment of skin and eye indtation, skin sensitization, mutagenicity, acute and chronic dermal and inhalation toxicity, reproductive toxicology, carcinogenicity etc. 

Toxicological Chronic toxicity Carcinogenicity Fertility study (multi-generation) Embryotoxicity (non-rodent) Acute/subacute toxicity in 2nd species Toxicokinetics... 

Toxicological studies—acute, subacute, and chronic toxicity carcinogenicity ... 

Conduct chronic (6-month) rodent toxicology study or combined rat chronic toxicity/carcinogenicity (2-year) study. 

Toxicology (Safety Pharmacology, Genotoxicitv, Subchronic, Chronic, Reproductive. Carcinogenicity) ... 

Toxicology including subchronic and chronic, reproductive carcinogenicity. Pharmacokinetics including toxicokinetics. 

Toxicological information acute effects, LD50 data, chronic effects, carcinogenicity, teratogenicity, mutagenicity. 

Chhabra, R. S., Huff, J. E., Schwetz, B. S., and Selkirk, J. (1990). An overview of prechronic and chronic toxicity/carcinogenicity experimental smdy designs and criteria used by the National Toxicology Program. Environ Health Perspect 86, 313-321. 

The duration for chronic toxicology studies depends on the projected duration of administration to humans (Table 2). The present consensus according to the FDA [5] is that 6-month rodent and 9-month nonrodent studies are sufficient for drug candidates intended for long-term human use, provided the candidate is studied in rats, or other appropriate species, to evaluate the potential for tumor production, i.e., a carcinogenicity study. 

Army. 1983a. Determination of the chronic mammalian toxicological effects of RDX Twenty-four month chronic toxicity/carcinogenicity study of hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX) in the Fischer 344 rat Phase V. Vol. 1. Contract no. DAMD17-C-9161. Frederick, MD U.S. Army Medical Research and Development Command, Fort Detrick. Document no. AD A160774. (authored by Levine BS et al.)... 

Furedi EM et al., Determination of the Chronic Mammalian Toxicological Effects of TNT (Twenty-Four Month Chronic Toxicity/Carcinogenicity Study of Trinitrotoluene (TNT) in the Fischer 344 Rat). Volume 1. Final Report on Phase 3, ITT Research Institute, Chicago, IL, Contract No. DAMD17-79-C-9120, Report No. ADA168637, U.S. Army Medical Research and Development Command, Fort Detrick, Frederick, MD, 1984. 

As of April 1989, the National Toxicology Program (NTP) and the National Cancer Institute (NCI up to 1981), have completed chronic toxicity/carcinogenicity studies on 385 chemicals (2). Of the chemicals studied, 63 were considered pesticides (GeneraT or Unclassified) (Tables I and II). Approximately 41% (26/63) of the pesticides eva-... 

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