Basis of Toxicity Testing

INTRODUCTION
PRELIMINARY CONSIDERATIONS
Introduction
The Agent Being Tested
The Vehicle
Routes of Administration
Species
Pharmacokinetics/Toxicokinetics
Biotransformation
Diet
Endpoints of Toxicity
Animal Numbers
ACUTE TOXICITY STUDIES
Purpose and Objectives
Study Design
Interpretation of Data
Utility of the LD50 Studies
Dermal Toxicity Studies
Ocular Toxicity Studies
Utility of Alternative Studies
Conclusions
SUBCHRONIC AND CHRONIC STUDIES
Introduction
Experimental Design
Evaluation of Results
Carcinogenicity Studies
REPRODUCTIVE TOXICOLOGY
Introduction
Male Reproductive Toxicity
Female Reproductive Toxicity
Preimplantation Studies
Teratogenicity
Embryo Culture
Harmonization
Screening Tests
MUTAGENESIS - CARCINOGENESIS
Introduction
Mutagenesis
Mutagenicity Testing with Prokaryotic Cell Systems
Mutagenicity Testing with Eukaryotic Cell Systems In Vitro
Mutagenicity Testing with Eukaryotic Cells In Vivo
The Impossibility - A Test for All Mutagens!
Carcinogenicity
Testing Strategies for Limited Bioassays
Long-Term Carcinogenicity Studies
RISK ASSESSMENT
Introduction
Hazard Identification
Dose-Response Assessment
Exposure Assessment
Risk Characterization
Carcinogen Classification
INDEX