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Follow-up actions from positive results of in vitro genetic toxicity testing.
| Content Provider | Semantic Scholar |
|---|---|
| Author | Dearfield, Kerry L. Thybaud, Véronique Cimino, Michael C. Custer, Laura Czich, Andreas Harvey, James Stephen Ware Hester, Susan Kim, James H. Kirkland, David E. Levy, Dan D. Lorge, Elisabeth Moore, Martha M. Ouédraogo-Arras, Gladys Schuler, Maik J. Suter, Willi Sweder, Kevin S. Tarlo, Kirk S. Benthem, Jan Van Goethem, Freddy Van Witt, Kristine L. |
| Copyright Year | 2011 |
| Abstract | Appropriate follow-up actions and decisions are needed when evaluating and interpreting clear positive results obtained in the in vitro assays used in the initial genotoxicity screening battery (i.e., the battery of tests generally required by regulatory authorities) to assist in overall risk-based decision making concerning the potential effects of human exposure to the agent under test. Over the past few years, the International Life Sciences Institute (ILSI) Health and Environmental Sciences Institute (HESI) Project Committee on the Relevance and Follow-up of Positive Results in In Vitro Genetic Toxicity (IVGT) Testing developed a decision process flow chart to be applied in case of clear positive results in vitro. It provides for a variety of different possibilities and allows flexibility in choosing follow-up action(s), depending on the results obtained in the initial battery of assays and available information. The intent of the Review Subgroup was not to provide a prescriptive testing strategy, but rather to reinforce the concept of weighing the totality of the evidence. The Review Subgroup of the IVGT committee highlighted the importance of properly analyzing the existing data, and considering potential confounding factors (e.g., possible interactions with the test systems, presence of impurities, irrelevant metabolism), and chemical modes of action when analyzing and interpreting positive results in the in vitro genotoxicity assays and determining appropriate follow-up testing. The Review Subgroup also examined the characteristics, strengths, and limitations of each of the existing in vitro and in vivo genotoxicity assays to determine their usefulness in any follow-up testing. |
| Starting Page | 177 |
| Ending Page | 204 |
| Page Count | 28 |
| File Format | PDF HTM / HTML |
| Alternate Webpage(s) | http://members.ecetoc.org/Documents/Document/20111219171004-Dearfield_2011_Env_Mol_Muta.pdf |
| PubMed reference number | 20963811v1 |
| Alternate Webpage(s) | https://doi.org/10.1002/em.20617 |
| DOI | 10.1002/em.20617 |
| Journal | Environmental and molecular mutagenesis |
| Volume Number | 52 |
| Issue Number | 3 |
| Language | English |
| Access Restriction | Open |
| Subject Keyword | Adverse reaction to drug Biological Science Disciplines Choose (action) Decision Making Environmental Illness Flowcharts (Computer) Follow-Up Report In Vitro [Publication Type] Subgroup A Nepoviruses |
| Content Type | Text |
| Resource Type | Article |
