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KMID : 1204320090250040269
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Laboratory Animal Research
2009 Volume.25 No. 4 p.269 ~ p.283
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Pathology-based Evaluation of Chemical Toxicity in the National Toxicology Program and Development of Toxicological Testing Methods for Human Risk Assessment - Carcinogenicity Studies of Dioxin and Dioxin-like Chemicals
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Yoon Byung-Il
Han Beom-Seok
Kim Yong-Baek
Kang Boo-Hyon
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Abstract
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Pathological data sets are critical for evaluation of carcinogenicity of chemicals in the preclinical studies using laboratory animals. Proper diagnosis and interpretation of non-neoplastic and neoplastic lesions, no matter what they are spontaneously developed or chemically induced, are prerequisite for determination of chemical carcinogenicity. The pathology-based criteria have been developed to evaluate the carcinogenic activity of chemicals; two positive results (clear evidence and some evidence), one uncertain finding (equivocal evidence), no observable effect (no evidence), and inadequate study. However, there are lots of things that we need to consider before determination of carcinogenic activity of chemicals such as adequacy of the experimental design and conduct, common and uncommon neoplasia, progression from benign to malignant neoplasia as well as from preneoplastic to neoplastic lesions, combining benign and malignant tumor incidence in the same organs, multiplicity in site-specific neoplasia, dose relationship, statistical significance of the observed tumor increase, concurrent control tumor incidences as well as historical control rate for a specific neoplasm, etc. In the present study, we introduce the carcinogenicity studies of dioxin and dioxin-like chemicals which had been performed as National Toxicology Program (NTP) in the USA for years, and discuss the pathology data-based approaching strategy for determination of carcinogenic activity of chemicals.
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KEYWORD
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Carcinogenicity evaluation, dioxin, dioxin-like chemicals, national toxicology program, toxicologic pathology
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