Related Experiment Video
Updated: Jun 8, 2026
17:28
Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation
Published on: June 17, 2015
Compilation and use of genetic toxicity historical control data
Makoto Hayashi1, Kerry Dearfield, Peter Kasper
1Biosafety Research Center, Foods, Drugs and Pesticides, Iwata, Japan.
Mutation Research
|October 12, 2010
Summary
Historical control data are crucial for interpreting genotoxicity test results and ensuring laboratory competence. Recommendations for their optimal use were developed at the 2009 International Workshop on Genotoxicity Testing.
Area of Science:
- Toxicology
- Genetics
- Laboratory Science
Background:
- Historical control data are vital for genotoxicity assay interpretation and validation.
- These data are used to assess concurrent control data and laboratory proficiency.
- The 2009 International Workshop on Genotoxicity Testing (IWGT) addressed the use of historical control data.
Purpose of the Study:
- To provide generic recommendations for the optimal use of historical control data in genotoxicity testing.
- To establish consistent guidelines applicable across various genotoxicity assays.
- To enhance the interpretation of genetic toxicity assay results using historical data.
Main Methods:
- Discussion and consensus-building among experts at the 2009 IWGT.
- Focus on negative control data, with consideration for positive control data.
- Development of general advice applicable to all genotoxicity assays.
Main Results:
- The working group provided recommendations for the optimal use of historical control data.
- Emphasis was placed on using historical data for assay interpretation and validation.
- Generic, assay-independent advice was formulated.
Conclusions:
- Historical control data play a significant role in genotoxicity testing beyond assay acceptance criteria.
- Standardized use of historical control data can improve the reliability of genotoxicity assessments.
- The IWGT's recommendations offer a framework for consistent application of historical control data.
Related Concept Videos
01:23Toxicity Testing in Animals
Toxicity tests in animals are grounded on two main assumptions: first, the effects observed in laboratory animals can be extrapolated to humans, especially when adjusted for body surface area; second, high-dose exposure in animals is essential to identify potential human hazards from lower doses. This is based on the quantal dose-response concept, which faces the challenge of extrapolating results from relatively few test animals to much larger human populations. For example, a 0.01% incidence...
01:25Mutagenicity and Carcinogenicity
Mutagenicity and carcinogenicity refer to the ability of drugs to cause genetic defects and induce cancer, respectively. The International Agency for Research on Cancer (IARC) classifies agents into four groups based on their carcinogenic potential. Group 1 agents are known human carcinogens; group 2A agents are probably carcinogenic to humans; group 3 agents lack data to support their role in carcinogenesis; and group 4 includes agents for which data support that they are not likely to be...
01:21Toxicokinetics: Overview
Studies that assess how a drug is absorbed, distributed, metabolized, and excreted (ADME) at toxic doses are termed toxicokinetics. Understanding toxicokinetics helps predict adverse drug reactions (ADRs) and manage toxicity in humans.Toxicokinetics differs from pharmacokinetics mainly in the dose levels studied, with toxicokinetics focusing on higher toxic doses. The kinetics at these levels can be non-linear due to altered physiological processes. Toxicodynamics examines the relationship...
01:25Drug Regulation
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
02:46Genetic Screens
Genetic screens are tools used to identify genes and mutations responsible for phenotypes of interest. Genetic screens help identify individuals or a group of people at risk of developing genetic diseases and help them with early intervention, targeted therapy, and reproductive options.
Forward genetic screens
Forward or “classical” genetic screens involve creating random mutations in an organism’s DNA using radiation, mutagens, or insertion of additional bases, which result in visible changes...
Forward genetic screens
Forward or “classical” genetic screens involve creating random mutations in an organism’s DNA using radiation, mutagens, or insertion of additional bases, which result in visible changes...
01:16In vitro Mutagenesis
To learn more about the function of a gene, researchers can observe what happens when the gene is inactivated or “knocked out,” by creating genetically engineered knockout animals. Knockout mice have been particularly useful as models for human diseases such as cancer, Parkinson’s disease, and diabetes.