Guidelines for carcinogen bioassay in small rodents by James M. Sontag

Cover of: Guidelines for carcinogen bioassay in small rodents | James M. Sontag

Published by National Cancer Institute ; for sale by the Supt. of Docs., U. S. Govt. Print. Off. in Bethesda, Md .

Written in English

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  • Carcinogens,
  • Biological assay

Edition Notes

Book details

StatementJames M. Sontag, Norbert P. Page, Umberto Saffiotti
SeriesNIH publication -- no. 76-801., National Cancer Institute carcinogenesis technical report series -- no. 1.
ContributionsPage, Norbert P., Saffiotti, Umberto, National Cancer Institute (U.S.)
The Physical Object
Pagination65 p. :
Number of Pages65
ID Numbers
Open LibraryOL25916692M

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Get this from a library. Guidelines for carcinogen bioassay in small rodents. [James M Sontag; Umberto Saffiotti; Norbert P Page; Carcinogenesis Program (National Cancer Institute (U.S.)); National Institutes of Health (U.S.)].

Guidelines for carcinogen bioassay in small rodents (OCoLC) Material Type: Government publication: Document Type: Book: All Authors / Contributors: James M Sontag; Umberto Saffiotti; Norbert P Page; Carcinogenesis Program (National Cancer Institute (U.S.)).

bioassay of chemicals for carcinogeni potentiac l in small rodents Th. e initial draf o thitf s documen wa writtestn followin a workshog p at which the Carcinogenesis Bioassa Program'y protocols s were reviewe bdy experts in th varioue s scientific disciplines applicable to.

Guidelines for carcinogen bioassay in small rodents. National Toxicology Program. Note to the Reader: These guidelines were published to establish standard procedures for toxicology testing in rodents.

PMID: Louis TA. Analysis of a random sample of 2-year carcinogen bioassays from the NCI data base. Fundam Appl Toxicol. Feb; 12 (2)– Bickis M, Krewski D.

Statistical issues in the analysis of the long-term carcinogenicity bioassay in small rodents: an empirical evaluation of statistical decision rules.

Fundam Appl by: The power of a negative carcinogen bioassay is limited by the fact that a % yield of tumors at a particular site is the minimum that can be shown to be statistically significant in an assay.

In consequence there is always an area of uncertainty in a Cited by: monitoring carcinogen bioassays, particularl iyn small rodents. Preparation of this document bega an discussio with n grou on monitorinp g guidelines that was conducte adt the National Cancer Institut oen June The NCI publication by Sontag et al.

inentitled Guidelines for Carcinogen Bioassay in Small Rodents, became a standard reference. This publication is known particularly for its definition of an MTD: ''The MTD is defined as the highest dose of the test.

Carcinogenicity Studies with Rodents Return to Redbook table of contents This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic.

Weisburger E.K. () Use of Animal Bioassay Data in Carcinogen Risk Assessment. In: Travis C.C. (eds) Carcinogen Risk Assessment. Contemporary Issues in Risk Analysis (Sponsored by the Society for Risk Analysis), vol : Elizabeth K.

Weisburger. IFSTP guidelines for the design and interpretation of the chronic rodent carcinogenicity bioassay * Author links open overlay panel John M.

Faccini (Chairman) 1 William R. Butler 2 Jean-Charles Friedmann 3 Robert Hess 4 Gerd K. Reznik 5 Nobuyuki Ito 6 Yuzo Hayashi 7 Gary M. Williams 8Cited by: committee. These guidelines were dissemi- nated to PMA members and FDA in and served to establish minimum standards of testing.

Some of the guidelines were revised in The NCI Technical Report #1 of February,entitled “Guidelines for Carcinogen Bioassay in Small Rodents” probably had the. Included are sections on the general principles of carcinogen bioassay, statistical analysis of screening bioassays, quantitative risk assessment, and regulatory considerations.

Some references have been included in more than one section, where appropriate. The practical aspects of conducting an adequate and valid carcinogen bioassay are. Bioassay and ancillary studies successfully identify tumor-causing agents in rodents, provide information on dose-response, and characterize other chemical-related toxicities.

Long-term animal bioassays for carcinogenicity are used regularly to determine whether chemical agents are capable of inducing cancer in exposed animals. Two important aspects of current bioassays are that testing covers a substantial portion.

The selection process for chemicals tested in the rodent carcinogenicity bioassay has been biased toward chemicals suspected of potential carcinogenicity. EPA/// March Workshop Report on EPA Guidelines for Carcinogen Risk Assessment Assembled by: Eastern Research Group, Inc.

6 Whittemore Street Arlington, MA EPA Contract for the Risk Assessment Forum Technical Panel on Carcinogen Guidelines U.S.

Environmental Protection Agency Washington, DC uooa 1G7Q. chemical being a carcinogen maybe obtained by comparing its structure and chemical and physi-cal characteristics with those of known carcino-gens and noncarcinogens.

This first stage in an orderly determination of whether or not a chem-ical is a carcinogen requires the gathering of all available information about it. The information. Rather than state that there are no animal models to study the carcinogenicity of arsenic (e.g., Goering et al., ), we believe a bioassay should be accomplished in rodents to resolve the debate whether arsenic is a human carcinogen that might not cause cancer in laboratory animals.

Of course, we now know that a major metabolite of arsenic Cited by: Abstract. Although various approaches to carcinogenesis testing have been proposed [e. g., Weisburger and Williams (1)] involving short-term in vitro tests and limited or short-term in vivo tests using a tumorigenic endpoint, chronic carcinogenesis bioassay in animals is still the method most commonly used to detect the potential carcinogenicity of chemicals to by: 1.

EPA//R/ September Guidelines for Carcinogen Risk Assessment Published on SeptemFederal Register 51() Risk Assessment Forum U.S. Environmental Protection Agency Washington, DC.

Ganglioneuromas in the Adrenal Medulla of F Rats Show all authors. Reznik 1 2. Reznik. Guidelines for Carcinogen Bioassay in Small Rodents, ed. Sontag, Page, Saffiotti, DHEW Publication No. (NIH) McGraw-Hill Book Cited by: The FDA has made scientifically justified changes to "draft" Redbook Chapter IV.C, Combined Chronic Toxicity/Carcinogenicity Studies with Rodents, and developed ChapterChronic.

Start studying Environmental Health. Learn vocabulary, terms, and more with flashcards, games, and other study tools. Search. Browse. rodents are given unrealistically high doses of test chemicals in order to increase probability of cancer mixture of both small solid particles and fine liquid droplets and exposure is linked to low birth.

This Guideline primarily covers assessment and evaluation of carcinogenicity in rodents (paragraph 2). The use of non-rodent species may be considered when available data suggest that they are more relevant for the prediction of health effects in humans.

The choice of species must be Size: KB. Interpretation of Chronic Toxicity and Carcinogenicity Studies in Rodents: Approaches to Dose Selection (Rhomberg et al.

) referred in this guidance document as Issues in Design & Interpretation Report, provides additional practical guidance on factors that influence dose selection in chronic bioassays.

Size: KB. TD 50 is analogous to LD 50, and a low value of TD 50 indicates a potent carcinogen, whereas a high value indicates a weak one. TD 50 is often within the range of doses tested, and does not indicate anything about carcinogenic effects at low doses because bioassays are usually conducted at or near the maximum tolerated dose (MTD).Cited by:   (Section ) When to Conduct an In-depth Analysis (Section ) Tools and Resources Needed to Support an In-depth Analysis(Section ) Evaluating Study(ies) on Which Exceeded Health Guidelines are Based(Section ) Reviewing Other Dose-response Data(Section ) Evaluating Substance-specific Factors that Can Increase or Decrease the.

Advantages of the Rat Medium-term Liver Bioassay. Good correlation with long-term carcinogenicity data. Predictability of carcinogenic dose with clear dose-response relationship. Positive detection of many non-genotoxic hepatocarcinogens. Detection of hepatocarcinogens reported only in mouse.

Small amount of test chemicals. The more difficult challenge is to devise reliable assays for the prediction and recognition of nongenotoxic rodent carcinogens (4,5).

Apart from the difficulty of deciding the relevance of such rodent carcinogens to humans, there is the possibility that the species, sex, and tissue specificity of such carcinogens will be uniquely associated with chemically induced changes that occur.

In the late s, the largest chronic bioassay ever undertaken (the so-called “megamouse” or ED01 Study) provided compelling experimental evidence of a threshold for chemically-induced bladder cancer in mice; even mouse liver carcinogenesis (which has an unusually high spontaneous rate in laboratory rodents and typically exhibits an.

CHAPTER 9 ANIMAL USE IN TOXICITY STUDIES Animal use in toxicity studies developments has been the Test Guidelines Programme of the Organisation for Economic Cooperation and Development (OECD), which has developed standardised methods of it is assumed that the effects detected in rodents or other.

The ethics of research involving animals. Guidelines for Carcinogen Risk Assessment. Washington, DC: US Environmental Protection Agency, Risk Assessment Forum. [Google Scholar] Guidelines, a process that began in the early s, progressed through several drafts, and was finalized in UK Committee on Carcinogenicity.

Single/short term exposure to by: National Cancer Institute Monograph Viruses of Laboratory Rodents on *FREE* shipping on qualifying cturer: Bethesda, NCI. High dose levels are required in animal carcinogenesis studies because of the low sensitivity of the bioassay. The uncertainty in the extrapolation is especially great for non-genotoxic carcinogens.

This is because non-genotoxic carcinogens are likely to have dose-response curve that are not linear and that include a threshold. Tests for human carcinogens using lifetime rodent bioassays are expensive, time-consuming and give uncertain results.

For most chemicals such tests are not cost-effective. Risk assessment and risk management Oxford Textbook of Public Health Risk assessment and risk management Gilbert S. Omenn and Elaine M. Faustman Introduction Definitions Hazard identification: epidemiology, lifetime rodent bioassay, short-term tests, and structure–activity relationships Epidemiology Lifetime rodent bioassays Short-term tests.

Biological Carcinogens The Role And Resurgence Of Viruses As cancer-info-Producing Agents. To the two great classes of agents that can cause cancer, chemicals and radiant energy, we now add a group of self-reproducing giant molecules called viruses.

GOOD PRACTICE GUIDELINES. The Selection of Non-rodent species for Pharmaceutical Toxicology David Smith, Robert Hubrecht. Series 3/Issue 1 – October Laboratory Animal Science Association, PO BoxTamworth, Staffordshire, B78 3QU. Telephone: Fax: – e-mail: [email protected] Size: 64KB.

Statistical issues in the design, analysis and interpretation of animal carcinogenicity studies are discussed. In the area of experimental design, issues that must be considered include randomization of animals, sample size considerations, dose selection and allocation of animals to experimental groups, and control of potentially confounding factors.

Both the Safe Drinking Water Act (SDWA) Amendments () and the Food Quality Protection Act direct U.S. Environmental Protection Agency (EPA) to conduct studies to identify and characterize health risks for groups that may be at greater risk than the general non-cancer health effects, the FQPA (but not the SDWA) mandates the use of Cited by: @article{osti_, title = {Mode-of-Action Uncertainty for Dual-Mode Carcinogens:Lower Bounds for Naphthalene-Induced Nasal Tumors in Rats Implied byPBPK and 2-Stage Stochastic Cancer Risk Models}, author = {Bogen, K T}, abstractNote = {As reflected in the USEPA Guidelines for Cancer Risk Assessment, some chemical carcinogens may have a site-specific Author: K T Bogen.Introduction.

Before a candidate compound may be administered to humans as part of Phase I (first-in-human) clinical trials, it must undergo rigorous safety and efficacy testing in non-clinical studies.

The International Conference on Harmonisation has laid out the requirements that must be satisfied by the non-clinical programme before a candidate compound may be administered .

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