Toxicology animal studies

Contemporary risk assessment practices for pesticides in foods require far more data than simply the residue levels evaluated in government monitoring programs. Exposure to pesticides is determined by multiplying the residue levels on food by the amount of the food item consumed once determined, exposure is compared with standard toxicological criteria derived from animal toxicology studies to determine the acceptability of the exposure. 

Wickhen Products Inc. FYI-OTS-0684-0286, Suppl Seq H. Di(2-Ethylhexyl) Adipate Animal Toxicology Studies. Report from Kolmar Research Center, May-August 1967. Washington, DC, Office of Toxic Substances, US Environmental Protection Agency, 1984... 

Improve animal toxicology study designs to incorporate use of validated biomarkers to characterize biomarker-response relationships that can be used to interpret human biomonitoring data. 

Toxicologic studies need to be expanded to incorporate collection of biomonitoring data in animals that can be related to humans. Much of the dose-response information used in risk assessments is derived from animal toxicologic studies, and these do not collect information on internal dose. Therefore, dose-response relationships can be expressed only in terms of external dose (such as milligrams per kilogram per day). However, to interpret biomonitoring data, the relationship between internal dose (biomarker concentration) and effect must be understood. 

Systematic presentation of animal toxicology studies and toxico-kinetic studies... 

To assess the relevance of these identified risks for humans. Any cause for concern derived from laboratory investigations, animal toxicology studies, and data in humans, may lead to a need for carcinogenicity studies. 

In addition, for preclinical studies to be useful in assuring the safety of human studies, sponsors should be able to relate the drug product being proposed for use in a clinical study to the drug product used in the animal toxicology studies that support the safety of the proposed human study. 

Toxicology—full data tabulation The sponsor should submit, for each animal toxicology study that is intended to support the safety of the proposed clinical investigation, a full tabulation of data suitable for detailed review. This... 

In the United States, GLP regulations (21 CFR 58) apply to safety or animal toxicology studies performed during research and development. These regulations define GLPs for conducting non-clinical laboratory studies that support or are intended to support applications for research or marketing permits for products... 

Animal toxicological studies have shown no mammalian carcinogenicity or teratogenicity for sorbic acid consumed at up to 10% of the diet. ° ... 

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