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    A Proposed In-Vivo/In-Vitro Approach to the Toxicological Assessment of Hazardous Waste

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    An in-vivo/in-vitro toxicological screen has been developed to evaluate potentially hazardous waste samples and process stream residuals. The biological methods employed in the screen are designed to be rapid, cost-effective, and capable of screening large numbers of wastes. Emphasis is placed on identifying a wide range of potential toxic responses associated with each waste by employing diverse test methods. The toxic end points identified by the screen include mutagenesis/carcinogenesis, general toxicology, neurotoxicology, reproductive toxicology, teratology, and immunotoxicology.

    The protocol, called the toxicological screen, involves the oral administration of waste material to male rodents for ten consecutive days. At the end of the ten-day period the whole animal, body tissues, and fluids are evaluated for toxicity. The toxicological screen also involves the oral treatment of pregnant rodents to wastes for ten consecutive days to assess transplacental effects and neonatal survival. A major goal of the toxicological screen is to maximize the amount and type of potential health effects information that can be obtained by exposing metabolically competent intact animals to complex waste mixtures.

    The toxicological screen is being validated by using a series of positive (and negative) control compounds of known and defined toxicity. The validation study ensures that the protocol will be capable of detecting biologically active wastes and will allow assessment of the protocol's use as a predictive tool for known chronic effects. An additional goal of the validation study is to identify a subset of the assays from the toxicological screen that most readily detect the toxic potential of the positive control compounds. These selected assays will constitute a prescreen for the entire protocol. The prescreen can then be used as a rapid means of prioritizing waste samples to be evaluated in the full toxicological screen.

    Initial trials of the validation study with four positive control compounds demonstrate the toxicological screen's ability to detect biologically active chemicals and to generate dose-response data.


    hazardous wastes, industrial wastes, environmental pollutants, toxic wastes, toxicity testing, hazardous waste assessment, solid waste, mutagenesis/carcinogenesis, general toxicology, immunotoxicology, neurotoxicology, reproductive toxicology, teratology

    Author Information:

    Lewtas, J
    Chief, Genetic Bioassay Branch, Health Effects Research Laboratory, U.S. Environmental Protection Agency, Research Triangle Park, NC

    Andon, B
    Hazardous Waste Program coordinator, Environmental Health Research and Testing, Research Triangle Park, NC

    Committee/Subcommittee: D34.07

    DOI: 10.1520/STP36374S