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Toxicology
Published in Samuel C. Morris, Cancer Risk Assessment, 2020
Toxicology is an experimental science. To understand, interpret, and use the results of toxicological experiments, the risk analyst must have an understanding of what is involved in those experiments that can shape the results. A number of issues affecting experimental design are discussed below. This discussion draws heavily on two authoritative reviews of issues involved in animal carcinogen testing (OSTP, 1984; NTP, 1984). Most carcinogen testing is done with standard designs in a routine manner. Since each chemical’s toxic properties are different, however, each test can involve its individual set of judgments associated with its design, performance, and interpretation. Table 8-3 compares some features of standard designs Although different regulatory agencies set their own design criteria, the leading U.S. organization in animal carcinogen testing is the National Toxicology Program (NTP). The NTP was established in 1978 to bring together the relevant programs, staff, and resources of the National Cancer Institute, National Institute of Environmental Health Sciences, National Center for Toxicological Research, and the National Institute for Occupational Health and Safety. Detailed reports of all NTP carcinogenesis bioassays are publicly available.
Adverse Effects, Adverse Reactions, and Drug Interactions
Published in David J. Owen, The Herbal Internet Companion, 2001
The U.S. National Toxicology Program was established in 1978 by the Secretary of Health and Human Services to coordinate toxicology research and testing activities within the Department of Health and Human Services (DHHS). The NTP represents such agencies as the Food and Drug Administration, the National Institutes of Health, and the Centers for Disease Control and Prevention. NTP is currently conducting studies to identify and characterize possible adverse health effects that may be associated with prolonged use or higher doses of some of the most popular medicinal herbs, including Ginkgo biloba, Echinacea angustifolia, and Panax quinquefolius (American ginseng). The U.S. National Cancer Institute (NCI) has also recommended that the program examine the safety of aloe vera, ginseng, kava, and milk thistle to determine whether these herbs contain carcinogenic compounds.
Critical review of renal tubule karyomegaly in non-clinical safety evaluation studies and its significance for human risk assessment
Published in Critical Reviews in Toxicology, 2018
The terms used in this literature search were as follows: renal/kidney tubule karyomegaly in laboratory animals (including karyomegalic nephritis/nephropathy, nuclear enlargement of kidney/renal tubule cells). The databases searched were as follows: Medline 1946 to August 2017, and Embase 1947 to August 2017, courtesy of the Royal Society of Medicine, London, UK. The databases of PubMed and Google Scholar were also searched using similar terms coupled with individual laboratory animal names. In addition, the Technical Report series on toxicity and carcinogenicity studies in rats and mice, published by the National Toxicology Program (NTP), were personally checked for instances of karyomegaly in the kidney. The NTP has been conducting subchronic and chronic toxicity/carcinogenicity studies on chemicals, agents or mixtures since its inception, first at the National Cancer Institute in Bethesda, MD, in 1978, and then at the National Institutes of Environmental Health Sciences in Research Triangle Park, NC. There have been almost 600 chemicals, agents or mixtures tested by NTP since establishment of the program. The NTP Archives have proven to be a most valuable resource of toxicologic pathology data, especially as, in most cases, subchronic toxicity and two-year carcinogenicity studies were conducted concurrently in both rats (usually F334/N strain) and mice (B6C3F1). Furthermore, the animal studies were carried out in accordance with the standards of Good Laboratory Practice (GLP), and the pathology examination segment in the spirit of GLP.