Hazard identification testing

IV. Concerns over growing numbers of nonrelevant positive findings in mammalian cell tests in vitro will also be counterbalanced by limiting the levels of cytotoxicity to at most 50% for in vitro chromosome aberration and micronucleus tests. This proposal is supported by an extensive review of results obtained with in vitro hazard identification testing and in vivo risk assessment testing in the pharmacentical industry. 

Hazard identification is defined as tlie process of determining whetlier human exposure to an agent could cause an increase in the incidence of a health condition (cancer, birtli defect, etc.) or whetlier exposure to nonliumans, such as fish, birds, and otlier fonns of wildlife, could cause adverse effects. Hazard identification cliaracterizes tlie liazard in terms of tlie agent and dose of the agent. Since tliere are few hazardous chemicals or hazardous agents for wliich definitive exposure data in humans exists, tlie identification of health hazards is often characterized by the effects of health hazards on laboratory test animals or other test systems. ... 

Gore, E.R., Immune function tests for hazard identification a paradigm shift in drug development, Basic Clin. Pharmacol. Toxicol., 98, 331, 2006. 

In order to understand the use and intent of the various immunotoxicology regulatory guidelines and guidance documents, the difference between two concepts familiar to toxicologists should be emphasized. Hazard, identification refers to a method which is essentially qualitative that is, it is designed to detect the ability of a test article to produce a certain (in the context of toxicology) adverse effect, without reference to exposure issues. Risk assessment, on the other hand, takes into consideration method, dose, and duration of exposure, condition(s) of the exposed population, and concurrent... 

European Centre for Ecotoxicology and Toxicology of Chemicals, Skin Sensitisation Testing for the Purpose of Hazard Identification and Risk Assessment, Mono. No. 29, Brussels, 2000. 

Chemical reactivity risk. See Risk assessment Chemical reactivity tests, 84-90 decision point, 90 deflagration screening tests, 85,87 reaction calorimetry, 88-90 screening data interpretation, 85, 86 small-scale screening tests, 87-88 Chemical structure and bonds, hazards identification, 80, 82 CHETAH program (ASTM), 79,82 Clean Air Act Amendments (CAAA) of 1990, 174... 

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